GOV.UK
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Levonorgestrel-containing emergency hormonal contraception: advice on interactions with hepatic enzyme inducers and contraceptive efficacy
Medicines or herbal remedies that induce CYP3A4 enzymes reduce blood levels of levonorgestrel, which may reduce emergency contraceptive efficacy.
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Posaconazole (Noxafil): tablets and oral suspension are not directly interchangeable
Switching from posaconazole oral solution to tablets has resulted in cases of dose-related toxicity, whereas switching from tablets to oral solution has resulted in underdosing and lack of efficacy.
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Idelalisib (Zydelig▼): updated indications and advice on minimising the risk of infection
Updated advice for healthcare professionals is available, after conclusion of a review of the safety of idelalisib, including the risk of infection.
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Letters sent to healthcare professionals in August 2016
A summary of safety letters sent to healthcare professionals in August 2016
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Riociguat (Adempas): not for use in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias
Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias should not be treated with riociguat in light of interim results from a recently terminated study.
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Letters sent to healthcare professionals in July 2016
A summary of letters sent to healthcare professionals in July 2016 to inform of safety information for riociguat and for posaconazole.
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Warfarin: reports of calciphylaxis
Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
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Citalopram: suspected drug interaction with cocaine; prescribers should consider enquiring about illicit drug use
Possible illicit drug use should be considered when prescribing medicines that have the potential to interact adversely.
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N-acetylcysteine: risk of false-low biochemistry test results due to interference with Siemens assays
N-acetylcysteine may interfere with assays from Siemens ADVIA Chemistry and Dimension/Dimension Vista instruments, leading to false-low biochemistry test results.
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Letters sent to healthcare professionals in June 2016
In June 2016, a letter was sent to healthcare professionals about Thalidomide Celgene.
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Canagliflozin (Invokana▼, Vokanamet▼): signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients
A signal of increased lower limb amputation (primarily of the toe) in people taking canagliflozin compared with placebo in a clinical trial in high cardiovascular risk patients is currently under investigation.
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Nexplanon (etonogestrel) contraceptive implants: reports of device in vasculature and lung
There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery.
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Topical miconazole, including oral gel: reminder of potential for serious interactions with warfarin
In view of reports of serious bleeding events in patients taking miconazole and warfarin, we are considering further measures to minimise the risk of potentially serious interactions between miconazole and warfarin.
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Letters sent to healthcare professionals in May 2016
In May 2016, letters were sent regarding Nexplanon (etonogestrel implant) and ERWINASE.
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BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
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Pomalidomide (Imnovid▼): risk of hepatitis B reactivation
Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.
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Idelalisib (Zydelig▼): interim measures following signal of serious infection and deaths related to infection found in clinical trials
There are new interim treatment recommendations for idelalisib for chronic lymphocytic leukaemia and follicular lymphoma in light of new findings from clinical trials outside its currently authorised drug combinations or indicated populations.
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Letters sent to healthcare professionals in April 2016
In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
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SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis
Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.
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Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy—updated advice to support early detection
Perform a quantitative serum anti-JCV antibody test—including index value—to support risk stratification for progressive multifocal leukoencephalopathy.
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Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy
Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.
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Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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Apomorphine with domperidone: minimising risk of cardiac side effects
Patients receiving apomorphine and domperidone require an assessment of cardiac risk factors and ECG monitoring to reduce the risk of serious arrhythmia related to QT-prolongation.
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Aflibercept (Zaltrap▼): minimising the risk of osteonecrosis of the jaw
Dental examination and appropriate preventive dentistry should be considered before treatment, especially for patients also treated with an intravenous bisphosphonate.
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Live attenuated vaccines: avoid use in those who are clinically immunosuppressed
Healthcare professionals working in primary and secondary care should ensure that clinically significant immunosuppression in a patient is identified before administration of a live attenuated vaccine.
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Meprobamate: licence to be cancelled
Following an EU wide review of meprobamate, the remaining licence holder in the UK has ceased manufacturing and the licence will be cancelled by the end of 2016.
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Paraffin-based skin emollients on dressings or clothing: fire risk
Smoking or a naked flame could cause patients’ dressings or clothing to catch fire when being treated with paraffin-based emollient that is in contact with the dressing or clothing.
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Letters sent to healthcare professionals in March 2016
In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.
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Trametinib (Mekinist▼): risk of gastrointestinal perforation and colitis
Use trametinib, authorised either as monotherapy or combined with dabrafenib, with caution in patients with risk factors for gastrointestinal perforation.
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Letters sent to healthcare professionals in February 2016
In February 2016, a letter was sent to healthcare professionals regarding medicines containing valproate.
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Valproate and of risk of abnormal pregnancy outcomes: new communication materials
Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations.
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Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia
Monitoring of blood electrolytes is essential in patients coprescribed a potassium-sparing diuretic and an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for heart failure.
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Letters sent to healthcare professionals in January 2016
In January 2016, letters were sent to healthcare professionals regarding fingolimod (Gilenya▼) and erlotinib (Tarceva)
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Nicorandil (Ikorel): now second-line treatment for angina - risk of ulcer complications
Updated advice on use of nicorandil as second-line treatment for stable angina - some ulcers may progress to complications unless treatment is stopped.
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Levonorgestrel-releasing intrauterine systems: prescribe by brand name
Levonorgestrel-releasing intrauterine systems should always be prescribed by brand name because products have different indications, durations of use, and introducers.
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Letters sent to healthcare professionals in December 2015
In December 2015, a letter was sent to healthcare professionals regarding Reminyl (galantamine hydrobromide).
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Thalidomide: reduced starting dose in patients older than age 75 years
Use a lower starting dose of thalidomide in patients with untreated multiple myeloma who are older than age 75 years.
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Mycophenolate mofetil, mycophenolic acid: new pregnancy-prevention advice for women and men
Mycophenolate mofetil and its active metabolite mycophenolic acid are associated with a high rate of serious birth defects and increased risk of spontaneous abortion.
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Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
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Antiretroviral medicines: updated advice on body-fat changes and lactic acidosis
With the exception of medicines containing zidovudine, stavudine, or didanosine, product information will no longer include warnings on fat redistribution or lactic acidosis.
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Letters sent to healthcare professionals in November 2015
In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate
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Crizotinib (Xalkori▼): risk of cardiac failure
There have been reports of severe, sometimes fatal, cases of cardiac failure in patients treated with crizotinib.
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Vemurafenib (Zelboraf▼): risk of potentiation of radiation toxicity
Prescribers should be aware of the risk of potentiation of radiation toxicity with vemurafenib when given before, during, or after radiotherapy
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Letters sent to healthcare professionals in October 2015
In October 2015, letters were sent to healthcare professionals to provide safety information for the anticancer medicines crizotinib and vemurafenib
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Mirabegron (Betmiga▼): risk of severe hypertension and associated cerebrovascular and cardiac events
Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
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Letters sent to healthcare professionals in September 2015
A letter was sent to healthcare professionals about mirabegron for symptomatic treatment of urgency, increased micturition frequency, or urgency incontinence.
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Proton pump inhibitors: very low risk of subacute cutaneous lupus erythematosus
Proton pump inhibitors (PPIs) are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas.
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Download the Yellow Card mobile app to report suspected adverse drug reactions
On 14 July 2015, the Yellow Card mobile app was launched - use it to report suspected reactions and receive up to date information on your medicines of interest.
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Pseudoephedrine and ephedrine: update on managing risk of misuse in the UK
Implementation of measures to regulate sales, together with the additional voluntary actions overseen by the pharmacy profession, has made an important contribution to managing the risk of misuse of pseudoephedrine and ephedrine in the UK.
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Letters sent to healthcare professionals in August 2015
A letter was sent regarding InductOs (solvent and matrix for implantation) to inform of a potential shortage.
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Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone
Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi▼) combination therapy, unless other antiarrhythmics cannot be given.
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Letters sent to healthcare professionals in July 2015
Last month, letters were sent regarding SGLT2 inhibitors and Xgeva▼ (denosumab).
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Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk
Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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Latanoprost (Xalatan): increased reporting of eye irritation since reformulation
Advise patients to tell their health professional if they experience severe eye irritation.
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New Yellow Card app for reporting suspected side effects
A new smartphone app for reporting side effects to the Yellow Card Scheme has now launched.
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Letters sent to healthcare professionals in June 2015
Last month, letters sent included one for the oral anticoagulant edoxaban.
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SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis
Test for raised ketones in patients with acidosis symptoms, even if plasma glucose levels are near-normal.
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High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk
EU review confirms that the cardiovascular risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac.
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Intrauterine contraception: uterine perforation—updated information on risk factors
The most important risk factors for uterine perforation are insertion during lactation and insertion in the 36 weeks after giving birth.
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Survey of medicines safety communications
Please complete our survey on how we communicate medicines safety issues.
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Hormonal pregnancy tests and birth defects: call for evidence
A group of independent experts will review all evidence provided; we will publish a report of the group’s findings.
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Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone
Avoid concomitant use of amiodarone with ledipasvir-sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given.
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Pomalidomide (Imnovid▼): risks of cardiac failure, interstitial lung disease and hepatotoxicity
New monitoring instructions to detect these side effects as soon as possible.
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Epoetin beta (NeoRecormon): increased risk of retinopathy in preterm infants cannot be excluded
Possible increased risk of retinopathy with epoetin beta in premature infants calls for careful consideration of options for preventing anaemia of prematurity.
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Letters sent to healthcare professionals in April 2015
Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya▼) and efavirenz (Sustiva).
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Hydroxyzine (Atarax, Ucerax): risk of QT interval prolongation and Torsade de Pointes
The maximum adult daily dose of hydroxyzine is now 100 mg.
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Codeine for cough and cold: restricted use in children
Do not use codeine in children under 12 as it is associated with a risk of respiratory side effects.
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High strength, fixed combination and biosimilar insulin products: minimising the risk of medication error
Several new high strength insulin products are now on the market.
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Letters sent to healthcare professionals in March 2015
Last month, letters were sent regarding ketoconazole HRA and radium-223 dichloride (Xofigo).
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Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia
Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months.
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Ferumoxytol (Rienso) intravenous iron no longer available for use
The licence-holder of ferumoxytol has voluntarily withdrawn it from the UK market for commercial reasons.
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Corticosteroids e-learning module launched
The new module helps clinicians understand how to identify, manage and avoid side effects when using corticosteroids.
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Report misleading medicines advertisements
If you are concerned about advertising you see for a medicine, please report it to MHRA or the industry self-regulatory body.
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Tiotropium delivered via Respimat compared with Handihaler: no significant difference in mortality in TIOSPIR trial
Take the risk of cardiovascular side effects into account when prescribing tiotropium delivered via Respimat or Handihaler to patients with certain cardiac conditions, who were excluded from clinical trials of tiotropium (including TIOSPIR).
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INOmax (nitric oxide) cylinders: valve defect might stop gas delivery early in some cylinders
While this defect is still being investigated, we remind you to always have a full spare cylinder loaded on the delivery device so the cylinders can be switched without delay.
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Drugs and driving: blood concentration limits set for certain drugs
We remind you that a new offence will be enforced from 2 March 2015 in England and Wales.
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Letters sent to healthcare professionals since November 2014
Since November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Triomel), and telavancin (Vibativ▼).
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Nitrofurantoin now contraindicated in most patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min/1.73m2
A short course (3 to 7 days) may be used with caution in certain patients with an eGFR of 30 to 44 ml/min/1.73m2
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Medicines related to valproate: risk of abnormal pregnancy outcomes
Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).
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Ustekinumab (Stelara): risk of exfoliative dermatitis
If you suspect exfoliative dermatitis caused by an adverse drug reaction to ustekinumab, stop treatment.
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Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasis
Measure serum immunoglobulin levels if recurrent infections develop.
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Oral diclofenac no longer available without prescription
Oral diclofenac is associated with a small increased risk of cardiovascular side effects and is therefore no longer available over the counter.
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Aceclofenac (Preservex): updated cardiovascular advice in line with diclofenac and COX-2 inhibitors
Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.
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Yellow Card extended to include devices, counterfeits and defective medicines
We have simplified our medicine and device incident report systems by bringing them all under the Yellow Card Scheme.
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Ivabradine (Procoralan) in the symptomatic treatment of angina: risk of cardiac side effects
New advice to minimise risk
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Isotretinoin (Roaccutane): reminder of possible risk of psychiatric disorders
Warn patients and family, monitor patients for signs of depression
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Hydroxyethyl starch intravenous infusions
To be used only in patients with acute blood loss and when crystalloids alone are not sufficient.
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Hydrogen peroxide: reminder of risk of gas embolism when used in surgery
Do not use in closed body cavities or on deep or large wounds.
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Veletri (epoprostenol) powder for solution for infusion: incompatibilities with some models of administration devices
Reports of reconstituted solution leaking from some models of extension sets and pumps.
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Boceprevir (Victrelis) and telaprevir (Incivo): predictive factors for sepsis, worsening liver function, and mortality
A European review identified baseline markers as predictive factors for morbidity requiring hospitalisation and mortality in cirrhotic patients.
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Agomelatine (Valdoxan): risk of liver toxicity
Reminder to test liver function before and during treatment.
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Ponatinib (Iclusig▼): risk of vascular occlusive events
Available evidence shows that the risk of blood vessel blockage with ponatinib is likely to be dose-dependent, however the data are insufficient to recommend reducing the ponatinib dose.
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Don't miss the latest drug safety advice!
We are changing our arrangements for sending out email alerts about Drug Safety Update.
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Chlorhexidine solutions: reminder of the risk of chemical burns in premature infants
A European review has considered MHRA evidence together with additional information from spontaneous reporting and published literature.
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Colobreathe (colistimethate sodium dry powder for inhalation): risk of capsule breakage - new instructions for use
We have received reports of Colobreathe (colistimethate sodium) capsules shattering when pierced by their inhaler device.
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Desiccants in blister packs: reminder of risk of ingestion
Take care to tell people receiving blister packs containing a desiccant that the desiccant should not be swallowed.
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Drugs and driving: clarification for Wales, Scotland, and Northern Ireland
The new offence introduced in July does not apply in Northern Ireland nor replace any existing offences of driving.
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Dexamethasone 4 mg/ml injection (Organon Laboratories Limited): reformulation with changes in name, concentration, storage conditions, and presentation
From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
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Basiliximab: indicated for renal transplantation only; efficacy and safety not shown in heart transplantation
Basiliximab (Simulect) is indicated for preventing acute organ rejection only for allogeneic renal transplantation in patients receiving organ transplantation for the first time.
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Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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Denosumab: updated recommendations
Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
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Ferumoxytol: risk of serious hypersensitivity reactions—contraindicated if any drug allergy; administer via infusion
New recommendations are being introduced to minimise the risk of serious hypersensitivity reactions with ferumoxytol.
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Domperidone: no longer available without prescription
People now need to have a medical assessment before taking domperidone to determine if it is suitable for them due to the risk of cardiac side effects.
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New guidance on reporting suspected adverse drug reactions in children
We are no longer requesting all suspected adverse drug reactions (ADRs) to be reported for children.
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Ofatumumab▼: reminder of risk of serious and fatal infusion reactions
Serious and fatal infusion reactions have occurred with ofatumumab and other anti-CD20 monoclonal antibodies.
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Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women
Emergency contraceptives remain suitable for all women regardless of the woman’s weight or body mass index (BMI).
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Drugs and driving: blood concentration limits to be set for certain controlled drugs in a new legal offence
The Department for Transport has introduced a new offence of driving with certain controlled drugs above specified limits in the blood; this is likely to come into force on 2 March 2015.
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Transdermal fentanyl “patches”: reminder of potential for life-threatening harm from accidental exposure, particularly in children
We remind you to provide clear information to patients and caregivers regarding risk of accidental patch transfer and ingestion of patches, and need for appropriate disposal of patches.
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Intravenous dantrolene: risk of undissolved crystals
Use a filter needle when drawing up reconstituted dantrolene solution.
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Ivabradine: carefully monitor for bradycardia
Emerging clinical trial evidence of increased cardiovascular risk.
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Combination use of medicines from different classes of renin-angiotensin system blocking agents: risk of hyperkalaemia, hypotension, and impaired renal function—new warnings
New warnings due to risk of hyperkalaemia, hypotension, and impaired renal function have been agreed following an EU-wide review.
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Voriconazole: reminder of risk of liver toxicity, phototoxicity, and squamous cell carcinoma
Test liver function before and during treatment and tell patients to avoid sunlight exposure.
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Zolpidem: risk of drowsiness and reduced driving ability
Taking zolpidem is associated with a risk of impaired driving ability the next day.
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Statins: benefits and risks
Statins (HMG-CoA reductase inhibitors) are widely used medicines for patients with lipid disorders and in the primary and secondary prevention of heart attack and stroke.
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Adrenaline auto-injector advice for patients
After every use, an ambulance should be called even if symptoms are improving, the individual should lie down with legs raised and, if at all possible, should not be left alone.
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Domperidone: risks of cardiac side effects
Indication restricted to nausea and vomiting, new contraindications, and reduced dose and duration of use.
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Yellow Card: update to form
Reporting suspected adverse reactions experienced by the woman or child associated with medicines taken during pregnancy.
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Tumour necrosis factor alpha inhibitors
Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
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Combined hormonal contraceptives: risk of venous thromboembolism
Non-hormonal or progestogen-only contraception should be considered in some situations.
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Methysergide: serious fibrotic reactions
Restricted use and new monitoring requirements.
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St John’s wort: interaction with hormonal contraceptives, including implants
St John’s wort interacts with hormonal contraceptives reducing the effectiveness and increasing the risk of unplanned pregnancy.
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Strontium ranelate: cardiovascular risk
Restricted indication and new monitoring requirements.
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Orlistat: theoretical interaction with antiretroviral HIV medicines
Initiate orlistat treatment only after careful consideration of the possible impact on efficacy of antiretroviral HIV medicines.
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Dorzolamide hydrochloride/timolol maleate (Cosopt) preservative-free eye drops: new pipette design
Old pipette design withdrawn after reported eye injuries.
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Cetuximab: new safety information available
importance of establishing wild type RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer
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Abraxane (paclitaxel, formulated as albumin-bound nanoparticles): potential presence of strands in intravenous infusion bag
If thin, translucent or white-to-yellow proteinaceous strands (1–2 mm in length) are visible, filtration is advised.
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Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small
A review of the latest evidence on the risk of thromboembolism advises to consider risk factors and remain vigilant for signs and symptoms. - the risk of blood clots with all low-dose CHCs is small - there is good evidence that the risk of venous thromboembolism (VTE) may vary between products, depending on the progestogen - CHCs that contain levonorgestrel, norethisterone, or norgestimate have the lowest risk of VTE - the benefits of any CHC far outweigh the risk of serious side effects - prescribers and women should be aware of the major risk factors for thromboembolism, and of the key signs and symptoms
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Temozolomide: risk of hepatic injury, including fatal hepatic failure—updated warnings and monitoring guidance
Liver function should be tested before and during treatment with temozolomide.
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Ofatumumab: screen for hepatitis B virus before treatment
Patients with active infection with this virus should not be treated with ofatumumab.
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Capecitabine: risk of severe skin reactions - discontinue treatment
Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with capecitabine.
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Prasugrel (Efient): increased risk of bleeding
New clinical trial information is available on the timing of the loading dose of prasugrel when used in patients with unstable angina or non-ST segment elevation myocardial infarction.
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Rituximab: screen for hepatitis B virus before treatment
Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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Clopidogrel: risk of acquired haemophilia
Reports of acquired haemophilia have been received in association with clopidogrel.
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Risperidone and paliperidone: risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery
Cases of intraoperative floppy iris syndrome (IFIS) during cataract surgery have been reported in patients taking the atypical antipsychotics risperidone or paliperidone.
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Cabazitaxel (Jevtana▼): risk of medication error resulting in overdose
It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel. It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel Pharmacies should review worksheets used in the preparation of cabazitaxel to ensure that they inform pharmacy staff to add the entire contents of the solvent vial to the concentrate vial
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Sodium valproate: Risk of neurodevelopmental delay in children following maternal use
Not for use in pregnancy unless there is no effective alternative.
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Short-acting β2 agonists: restricted use for tocolysis in premature labour
Use has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review.
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Mefloquine: strengthened warnings on neuropsychiatric side effects
A recent review of the prescribing information has led to strengthened warnings and new measures to help minimise risks. To minimise the risk of these adverse reactions, mefloquine must not be used for chemoprophylaxis in patients with active or a history of psychiatric disturbances such as depression, anxiety disorders, schizophrenia, or other psychiatric disorders.
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Antiepileptic drugs: new advice on switching between different manufacturers’ products for a particular drug
Different antiepileptic drugs (AEDs) vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’ products of a particular drug may cause adverse effects or loss of seizure control.
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New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼)
Risk of serious haemorrhage—clarified contraindications apply to all 3 medicines.
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Intravenous iron and serious hypersensitivity reactions
Clarification of advice on new recommendations regarding initial test dose.
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Filgrastim and pegfilgrastim: risk of capillary leak syndrome
Capillary leak syndrome (CLS) has been reported in recipients of filgrastim, including patients undergoing chemotherapy and a healthy donor undergoing peripheral blood progenitor-cell mobilisation; it has also been reported in recipients of pegfilgrastim undergoing chemotherapy. Prescribers should monitor patients and healthy donors for signs and symptoms of capillary leak syndrome (CLS), and should give standard symptomatic treatment immediately if symptoms occur.
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Panitumumab: treatment of metastatic colorectal cancer
Importance of establishing wildtype RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer.
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Diclofenac: public consultation on availability as a pharmacy medicine
Public consultation launched on the continued availability of oral diclofenac as a pharmacy (P) medicine and on risk-minimisation measures advised by the Commission on Human Medicines.
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Metoclopramide: risk of neurological adverse effects
Restricted dose and duration of use.
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Oral ketoconazole: do not prescribe or use for fungal infections—risk of liver injury outweighs benefits
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Caffeine for apnoea of prematurity
All products to be named and prescribed as caffeine citrate.
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Intravenous iron and serious hypersensitivity reactions: strengthened recommendations
New strengthened recommendations to manage and minimise risk.
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Ondansetron for intravenous use: posology in patients age 65 years or older
New advice on dilution and administration in patients age 65 years or older refers only to the indication for prevention of chemotherapy-induced nausea and vomiting.
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Retigabine (Trobalt▼): indication restricted to last-line use and new monitoring requirements
Reports of pigment changes in ocular tissue, skin, lips or nails.
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Codeine for analgesia: restricted use in children because of reports of morphine toxicity
Codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone.
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Ondansetron for intravenous use: dose-dependent QT interval prolongation
New specific guidance on dose-dependent prolongation of QTc with ondansetron.
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The Pharmacovigilance Risk Assessment Committee
Strengthening surveillance of medicines throughout the EU
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Oral retinoids: pregnancy prevention—reminder of measures to minimise teratogenic risk
The risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy.
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Cyproterone acetate with ethinylestradiol (co-cyprindiol): balance of benefits and risks remains positive
Updated prescribing advice provided.
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Codeine: restricted use as analgesic in children and adolescents after European safety review
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Hydroxyethyl starch intravenous infusion: suspension of licences
Clinical trials have reported an increased risk of renal dysfunction and mortality in critically ill or septic patients who received hydroxyethyl starch (HES) compared with crystalloids.
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Diclofenac: new contraindications and warnings
New recommenedations after a Europe-wide review of cardiovascular safety.
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Black Triangle (▼) medicines part of an EU-wide scheme
Remember to report any suspected adverse reactions
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Liothyronine 20 microgram tablets: continuity of supply and potential need for patient monitoring
Recent interruption to the supply of liothyronine 20 microgram tablets from Amdipharm Mercury.
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Tolvaptan (Samsca▼): risk of liver injury
liver-function testing recommended in patients with symptoms that may indicate liver injury.
-
Thalidomide: risk of second primary malignancies
Healthcare professionals should consider this risk when deciding whether to treat patients with thalidomide monitor for the occurrence of these conditions.
-
Insulin degludec (Tresiba▼): available in additional higher strength
Care needed to minimise risk of error, including training for patients.
-
Cilostazol (Pletal): risks of cardiovascular and bleeding events
Indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines Furthermore, cilostazol is now contraindicated in patients with any of the following: Unstable angina, recent myocardial infarction or coronary intervention (within 6 months) a history of severe tachyarrhythmia those receiving two or more other antiplatelet or anticoagulant treatments For patients starting cilostazol, prescribers should assess benefit after 3 months of treatment, and should stop treatment if patients have not made clinically relevant improvements in walking distance.
-
Recent drug-name confusion
Please be vigilant as life-threatening errors may occur
-
Botulinum toxin type B (Neurobloc): serious known risks
Risks such as toxin spread reported mostly with off-label use.
-
Aqueous cream: may cause skin irritation
May cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content.
-
Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment
Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s) requiring anti-coagulant treatment.
-
Sprayable fibrin sealants (Evicel, Tisseel and Artiss): updated guidance
Updated guidance on minimising risk of life-threatening and fatal air embolism.
-
Denosumab 60 mg (Prolia▼)
Rare cases of atypical femoral fracture with long-term use.
-
Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions
Routine monitoring of liver function now recommended.
-
Roflumilast (Daxas▼): risk of suicidal behaviour
Avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur.
-
Fingolimod (Gilenya▼): bradycardia and heart block
Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
-
Tredaptive (combined niacin-laropiprant): no longer for prescribing
Preliminary HPS2-THRIVE trial failed to show benefit outweighs risks
-
Codeine-containing pain relief in children
Safety review initiated following post-surgical fatalities in ultra-rapid metabolisers
-
Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions
Risk of serious skin-related adverse drug reactions, including Stevens-Johnson syndrome, occurring with carbamazepine may be increased in the presence of the HLA-A*3101 allele in patients of European descent or Japanese origin.
-
Reporting suspected adverse drug reactions to vaccines and biological medicines
The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.
-
Human papillomavirus vaccine Cervarix: balance of risks and benefits remains clearly positive
A safety review conducted at the end of its routine use during the ongoing human papillomavirus immunisation programme has found that no new risks have been identified for Cervarix, and that the balance of its risks and benefits remains clearly positive.
-
Pseudoephedrine and ephedrine: update on managing risk of misuse
The Commission on Human Medicines recommend that existing levels of monitoring, education, and awareness measures by pharmacists should be maintained.
-
Non-steroidal anti-inflammatory drugs (NSAIDs): cardiovascular risks
Further evidence that the cardiovascular risk with diclofenac is higher than other non-selective NSAIDs and similar to the selective COX-2 inhibitors.
-
Simvastatin: dose limitations with concomitant amlodipine or diltiazem
The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.
-
Denosumab: monitoring recommended
Fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment.
-
Agomelatine (Valdoxan/ Thymanax): risk of dose-related hepatotoxicity and liver failure
Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased.
-
Intravenous 0.18% saline/4% glucose solution (‘hypotonic saline’) in children: reports of fatal hyponatraemia
Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.
-
Treating paracetamol overdose with intravenous acetylcysteine: new guidance
New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine including an updated treatment nomogram.
-
Dipeptidylpeptidase-4 inhibitors: risk of acute pancreatitis
There have been reports of acute pancreatitis associated with drugs in the dipeptidylpeptidase-4 (DPP-4) inhibitor class of antidiabetic agents (‘gliptins’).
-
Oseltamivir (Tamiflu): changed concentration and dosing dispenser of oral suspension
Healthcare professionals should advise patients and/or carers of the changes in the dose, packaging, dose dispenser and leaflet.
-
Panitumumab (Vectibix): risk of necrotising fasciitis
Five cases of necrotising fasciitis have been reported in patients treated with panitumumab in combination with chemotherapy.
-
Levofloxacin: some indications restricted
Levofloxacin (a fluoroquinolone antibiotic) is unfavourable as first-line treatment for several indications.
-
Calcitonin (Miacalcic): increased risk of cancer with long-term use
Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.
-
Ondansetron (Zofran): important new intravenous dose restriction
New maximum single intravenous dose of ondansetron for the management of chemotherapy-induced nausea and vomiting (CINV) restricted due to risk of QTc prolongation.
-
Doripenem (Doribax▼): updated dosing recommendations
Previous dosing regimens for doripenem in such patients found to be insufficient.
-
Simvastatin: updated advice on drug interactions
Updated contraindications and maximum dose recommendations when taken with a number of other medicines.
-
Dabigatran (Pradaxa▼): risk of serious haemorrhage
Contraindications clarified and reminder to monitor renal function.
-
Glucose solutions: false blood glucose readings when used to flush arterial lines
False blood glucose readings when used to flush arterial lines leading to incorrect insulin administration and potentially fatal hypoglycaemia.
-
Oral tacrolimus products: prescribe and dispense by brand name only, to minimise the risk of inadvertent switching between products, which has been associated with reports of toxicity and graft rejection
The growing number of oral tacrolimus products available on the market increases the potential for inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. If a prescriber considers that switching a patient to a different brand of oral tacrolimus would be of benefit, the change requires careful supervision and therapeutic monitoring by an appropriate specialist
-
Tacrolimus ointment (Protopic): possible risk of malignancies including lymphomas and skin cancers
Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.
-
Febuxostat (Adenuric▼): stop treatment if signs or symptoms of serious hypersensitivity
Febuxostat must be stopped immediately if hypersensitivity occurs and must not be re-started in patients who have ever developed a hypersensitivity reaction to febuxostat.
-
Caffeine citrate: 2 products of different strengths now available
Care must be taken with dosing as the 2 products are not equivalent.
-
Fingolimod (Gilenya▼): not recommended for patients at known risk of cardiovascular adverse events
New advice for extended early monitoring for those with significant bradycardia or heart block after first dose.
-
Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
Patients who present with acute or worsening signs and symptoms of keratitis should be referred promptly to an ophthalmology specialist.
-
Antipsychotics: initiative to reduce prescribing to older people with dementia
Concerns over recent years about the use of antipsychotics to treat the behavioural and psychological symptoms of dementia (BPSD).
-
Tolvaptan (Samsca▼): over-rapid increase in serum sodium risking serious neurological events
Careful monitoring of serum sodium important, co-administration of other drugs that may increase serum sodium not recommended.
-
Proton pump inhibitors in long-term use: increased risk of fracture
Recent epidemiological evidence of an increased risk of fracture with long-term use of proton pump inhibitors (PPIs).
-
Proton pump inhibitors in long-term use: reports of hypomagnesaemia
Healthcare professionals should consider measuring magnesium levels before starting PPI treatment and repeat measurements periodically during prolonged treatment.
-
Aliskiren (Rasilez▼): risk of cardiovascular and renal adverse reactions
New contraindications and warnings for combination of aliskiren (Rasilez) with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
-
Teva levothyroxine 100 microgram tablets: suspension of marketing authorisation
Following a review by the Commission on Human Medicines (CHM), the marketing authorisation (licence) for levothyroxine 100 microgram tablets manufactured by Teva has been suspended.
-
Unlicensed imported vitamin D (colecalciferol) capsules: potential peanut oil and soya oil allergens
Healthcare professionals should be aware that these capsules contain potential allergens.
-
Blue dyes: risk of serious allergic reactions
Surgeons reminded to have competent personnel and emergency facilities available for at least 1 hour after administration of the blue dye.
-
Chlorhexidine: reminder of potential for hypersensitivity
Healthcare professionals are reminded that chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock.
-
Public consultation on new pharmacovigilance legislation
How to comment on new pharmacovigilance legislation.
-
Statins: risk of hyperglycaemia and diabetes
Statin use may be associated with a level of hyperglycaemia in some patients where formal diabetes care is appropriate.
-
Atomoxetine (Strattera▼): increases in blood pressure and heart rate
New contraindications, warnings, and advice for monitoring.
-
Angiotensin II receptor antagonists: evidence does not suggest any link with cancer
Evidence does not support any increased risk of cancer in patients who use these medicines.
-
Citalopram and escitalopram: QT interval prolongation
New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
-
Lenalidomide (Revlimid▼): update on risk of second primary malignancy
Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
-
Paracetamol: reminder of updated dosing recommendations for children
Reminder that paediatric paracetamol liquids had been developed to ensure children receive optimum dosing for their age.
-
Dronedarone (Multaq▼): cardiovascular, hepatic and pulmonary adverse events – new restrictions and monitoring requirements
Following new evidence of cardiovascular, hepatic and pulmonary risk, a review of dronedarone has concluded that the benefits of treatment continue to outweigh the risks for the maintenance of sinus rhythm after successful cardioversion in a limited population of patients with paroxysmal or persistent atrial fibrillation; however, in light of safety concerns dronedarone should only be prescribed after other treatment options have been considered. To support safer use, patients should have their treatment reviewed at the next routine appointment to ensure that they remain eligible for dronedarone treatment according to the revised prescribing information, including new restrictions on use.
-
Aqueous calamine cream: do not use before X-ray examination
Don't apply aqueous calamine cream onto the skin before an X-ray examination because it may affect the outcome of the radiograph.
-
Enzira/CSL Biotherapies and Viroflu/Inflexal V influenza vaccines and risk of febrile reactions in children under 5 years
Use alternative vaccines in under 5s and report suspected adverse reactions
-
Calcium and vitamin D: no prescribing changes
Studies of cardiovascular risk don’t support prescribing changes.
-
Buccal midazolam (Buccolam▼): new authorised medicine for paediatric use
Care needed when transferring from unlicensed formulations.
-
Reboxetine: benefit-risk balance reviewed
A UK and Europe-wide review of available efficacy and safety data confirmed that reboxetine has benefit over placebo in its authorised indication.
-
Antipsychotics: risk of extrapyramidal effects or withdrawal symptoms in newborns
Risk of extrapyramidal effects or withdrawal symptoms (or both) in newborns after maternal use of antipsychotics during the third trimester of pregnancy.
-
Systemic fusidic acid and interaction with statins
There is a risk of rhabdomyolysis if Systemic fusidic acid (Fucidin) is given with statins.
-
Onsenal▼ (Celecoxib) withdrawn from EU market
Onsenal▼ (celecoxib) is no longer approved in Europe for the reduction of intestinal polyps in familial adenomatous polyposis (FAP).
-
Traditional Chinese medicines containing lei gong teng (tripterygium wilfordii)
Risk of serious side effects on fertility, the liver, kidneys, immune system, blood, and heart.
-
Pioglitazone: risk of bladder cancer
Use of pioglitazone is associated with a small increased risk of bladder cancer.
-
Vimpat▼ (lacosamide) 15 mg/mL syrup: recall due to quality defect
Recall will begin in September 2011 to allow sufficient time for patients to be switched to suitable alternatives.
-
Addiction to benzodiazepines and codeine
Supporting safer use
-
Octagam intravenous immunoglobulin 5% and 10%: licence suspensions lifted
Suspension of the licences (marketing authorisations) for Octagam (intravenous human normal immunoglobulin 5% and 10%) lifted.
-
Dexrazoxane (Cardioxane): restriction of use
Use restricted to adults with advanced or metastatic breast cancer only.
-
Thalidomide: risk of arterial and venous thromboembolism
Increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events for patients treated with thalidomide.
-
Paracetamol: updated dosing for children to be introduced
Updated dosing for paediatric paracetamol liquids has been developed to ensure children receive the optimum dose for their age.
-
Time to report
A reminder to healthcare professionals to fill out Yellow Card reports.
-
Yasmin: risk of venous thromboembolism higher than levonorgestrel-containing pills
Risk of venous thromboembolism (VTE) for drospirenone-containing combined oral contraceptives (COCs), including Yasmin, is higher than for levonorgestrel-containing COCs.
-
Bisphosphonates: atypical femoral fractures
Atypical femoral fractures reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis.
-
Nicobrevin anti-smoking preparation withdrawn from the market
Risks of Nicobrevin outweigh any benefits.
-
Prasugrel (Efient▼): rare but serious hypersensitivity reactions
Healthcare professionals should be aware of this risk when prescribing prasugrel.
-
Atypical (second-generation) antipsychotics
Reminder to monitor and manage weight, glucose, and lipid levels.
-
Tigecycline (Tygacil▼): increased mortality in clinical trials
Use only when other antibiotics are unsuitable
-
Vivaglobin solution for subcutaneous injection: rare risk of thromboembolic events
Where possible, use an appropriate alternative therapy for patients at increased risk of thrombosis.
-
Stavudine (Zerit): increased risk of potentially severe adverse effects
Stavudine should only be used when there are no appropriate alternatives, and for the shortest possible time.
-
Modafinil (Provigil): now restricted to narcolepsy
Further information is available to support safer use
-
Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy is increased in patients who have had previous immunosuppressant treatment
Risk of developing progressive multifocal leukoencephalopathy (PML) associated with natalizumab is increased in patients who have had previous immunosuppressant therapy.
-
Omalizumab: potential risk of arterial thrombotic events
Prescribers should be vigilant for possible thrombotic adverse reactions.
-
Lenalidomide: risk of thrombosis and thromboembolism
Patients receiving lenalidomide for management of multiple myeloma should be closely monitored for evidence of arterial and venous thromboembolic events.
-
Dianeal, Extraneal, and Nutrineal peritoneal dialysis solutions
Risk of aseptic peritonitis with Dianeal, Extraneal, and Nutrineal peritoneal dialysis solutions due to possible presence of endotoxin.
-
Daptomycin: risk of eosinophilic pneumonia
If eosinophilic pneumonia is suspected, daptomycin should be discontinued immediately and if appropriate the patient treated with corticosteroids.
-
Insulin combined with pioglitazone: risk of cardiac failure
If pioglitazone is used in combination with insulin patients should be observed for signs and symptoms of heart failure, weight gain, and oedema.
-
(Dextro)propoxyphene: new studies confirm cardiac risks
(Dextro)propoxyphene can have serious effects on the electrical activity of the heart (resulting in prolongation of the P-R and Q-T intervals, and widened QRS complexes), even at normal therapeutic doses.
-
Bevacizumab and sunitinib: risk of osteonecrosis of the jaw
Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib.
-
Implanon contraceptive implant: information for women and healthcare professionals
-
Moxifloxacin: increased risk of life-threatening liver reactions and other serious risks
Use in pelvic inflammatory disease only when other antibacterials are inappropriate or ineffective.
-
Sitaxentan (Thelin▼): worldwide withdrawal from the market
Sitaxentan (Thelin▼) withdrawn due to hepatotoxicity.
-
Seasonal flu vaccines
No evidence of increased risk of febrile convulsions in children.
-
Saquinavir: update on potential risk of arrhythmia
Saquinavir at a reduced dose for the first week of treatment
-
Fibrates: first-line treatment not recommended
Healthcare professionals should not prescribe them to newly diagnosed patients as first-line treatment, except for those with severe hypertriglyceridaemia or those who cannot take statins.
-
Memantine pump device (Ebixa): risk of medication errors
Differences in dose delivery between the pump device and dropper device for memantine.
-
Tiotropium
Safety studies of Spiriva Respimat▼
-
Tamoxifen for breast cancer
Drug interactions involving CYP2D6, genetic variants, and variability in clinical response
-
Oral bisphosphonates: oesophageal cancer risk—insufficient evidence of a link
Insufficient evidence to confirm a link between oral bisphosphonate use and an increased risk of oesophageal cancer.
-
Yellow Card Scheme update: seasonal flu vaccines in children
Report of febrile promptly.
-
Implanon contraceptive implant: changing to Nexplanon
All healthcare professionals trained in inserting Implanon must make sure they are trained in using Nexplanon before the changeover.
-
Human papillomavirus immunisation programme
Second year safety review
-
Rosiglitazone: recommended withdrawal from clinical use
Suspension of the marketing authorisations of rosiglitazone (Avandia, Avandamet) recommended across the European Union.
-
Codeine-containing liquid over-the-counter medicines.
Should not be used for cough under 18 years
-
Pandemic vaccines and antivirals: safety review
Outline of the safety experience of these medicines in the UK from our proactive safety monitoring strategy.
-
Mercaptamine and mercaptopurine: confusion between drug names
Prescribers should remain vigilant with regards to the similarity of these 2 drug names.
-
Long-acting β2-agonists: reminder for use in children and adults
Benefits of these medicines used in conjunction with inhaled corticosteroids (ICS) in the control of asthma symptoms in children outweigh any apparent risks.
-
Medstream Implantable Drug Pumps
Check pumps after MRI.
-
Inhaled and intranasal corticosteroids
Risk of psychological and behavioural side effects.
-
Pseudoephedrine and ephedrine: managing risk of misuse
Update on managing risk of misuse.
-
Isotretinoin: risk of serious skin reactions
Erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis reported in association with isotretinoin - may result in hospitalisation, disability, life-threatening events, or death.
-
Calcium gluconate injection in small-volume glass containers: new contraindications due to aluminium exposure risk
Aluminium can be leached from glass after contact with calcium gluconate solution, leading to a risk of exposure to aluminium.
-
Modafinil: restricted use recommended
European Medicines Agency has recommends the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy - should no longer be used for obstructive sleep apnoea or chronic shift work sleep disorder.
-
Topical ketoprofen: reminder on risk of photosensitivity reactions
European Medicines Agency says further measures should be put in place to minimise the risk of adverse skin reactions.
-
Orciprenaline sulphate (Alupent): reminder of withdrawal from the market
Patients should be transferred to alternative bronchodilator therapy.
-
Intravenous paracetamol (Perfalgan ▼): risk of accidental overdose
Risk of accidental overdose, particularly in infants and neonates.
-
Bevacizumab (Avastin): hypersensitivity and infusion reactions
Infusion reactions and hypersensitivity reactions have been reported commonly during treatment with Avastin.
-
Rivastigmine (Exelon) transdermal patch: risk of medication errors
Medication errors and inappropriate use of the rivastigmine transdermal patch have been reported, some of which resulted in overdose.
-
Quinine: not to be used routinely for nocturnal leg cramps
Quinine should only be considered when cramps cause regular disruption of sleep.
-
PIL of the month: Durogesic D Trans Transdermal Patch
Best practice example of a patient information leaflet.
-
Panitumumab (Vectibix): serious hypersensitivity reactions
New reports of serious hypersensitivity reactions (including anaphylaxis) in patients receiving panitumumab, some of which were fatal.
-
Antidepressants: risk of fractures
Healthcare professionals should be aware of epidemiological data showing a small increased risk of fractures associated with the use of TCAs and SSRIs, and should take this risk into account in their discussions with patients and in prescribing decisions
-
Carbapenems: concomitant use with valproic acid not recommended
A clinically significant interaction between carbapenems and valproic acid results in reduced valproate plasma concentrations with potential for inadequate seizure control.
-
SSRIs and SNRIs: risk of persistent pulmonary hypertension in the newborn
Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in the later stages, may increase the risk of persistent pulmonary hypertension in the newborn.
-
Simvastatin: increased risk of myopathy at high dose (80 mg)
There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin.
-
Intravenous zoledronic acid: adverse effects on renal function
Zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors.
-
Parenteral amphotericin B: fatal overdose risk due to confusion between lipid-based and non-lipid-based formulations
There is a potential risk of fatal overdose due to confusion between lipid-based and non-lipid-based formulations of parenteral amphotericin B.
-
Clopidogrel and proton pump inhibitors: interaction—updated advice
In light of the most recent evidence, the previous advice on the concomitant use of clopidogrel with proton pump inhibitors has now been modified.
-
Rifadin infusion (rifampicin): new solvent formulation and changes to compatible diluents
The solvent used in the preparation of Rifadin infusion has been reformulated.
-
Becaplermin (Regranex) for diabetic ulcers
Contraindicated in patients with any known current cancer
-
Drug Safety Update gains NHS Evidence accreditation
NHS Evidence Accreditation Scheme recognises organisations that demonstrate high standards in producing health or social care guidance.
-
Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy increases after 2 years of therapy
The risk of developing progressive multifocal leukoencephalopathy (PML) with natalizumab increases after 2 years of therapy.
-
Sirolimus: different immunoassays for therapeutic drug monitoring—risk of incorrect dose adjustment
Needs a summary
-
Fluoxetine: possible small risk of congenital cardiac defects
Recent epidemiological evidence suggests a possible small increased risk of congenital cardiac defects in association with fluoxetine in early pregnancy, similar to that seen with paroxetine.
-
Report adverse reactions associated with intra-articular use of local anaesthetics
The Food and Drug Administration (FDA) has received 35 reports of chondrolysis involving patients given continuous intra-articular infusions of local anaesthetics.
-
Off-label intraocular use of recombinant tissue plasminogen activator
Risk of intraocular lens opacification.
-
Orlistat safety update
A recent Europe-wide review of the safety information for alli has led to a number of updates, which bring the product information in line with that for Xenical.
-
Nicotine replacement therapy and harm reduction
Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
-
Sibutramine: suspension of EU licences recommended
Evidence indicates risks outweigh benefits.
-
Recognised safety profile of flu antivirals and vaccines confirmed
No unexpected new safety issues have been identified from Yellow Card reports.
-
Gadolinium-containing contrast agents: new advice to minimise the risk of nephrogenic systemic fibrosis
Gadolinium-containing contrast agents are associated with a varying degree of risk of nephrogenic systemic fibrosis.
-
Methylphenidate: new patient information
The design and content of the Patient Information Leaflets for methylphenidate products are being updated with the latest guidance on safe and effective use for patients and carers
-
Phenytoin: risk of Stevens-Johnson syndrome associated with HLA-B*1502 allele in patients of Thai or Han Chinese ethnic origin
If patients are known to be HLA-B*1502-positive, phenytoinshould be avoided when alternative therapy can be given.
-
Finasteride: potential risk of male breast cancer
Patients should be advised to promptly report to their doctor any changes in their breast tissue such as lumps, pain, or nipple discharge.
-
Rituximab: progressive multifocal leukoencephalopathy in a patient
A case of progressive multifocal leukoencephalopathy (PML) with a fatal outcome was reported in a patient with rheumatoid arthritis who had not previously received treatment with methotrexate or a TNF antagonist.
-
Warfarin: product information to be amended to give clearer, up-to-date advice
We continue to receive a substantial number of serious and fatal adverse event reports for warfarin through our Yellow Card Scheme.
-
Drug alert: recall of Gaviscon Advance Peppermint Flavour, Boots Heartburn Relief Peppermint Flavour, Peptac Peppermint Liquid, and Peptac Liquid Aniseed Flavour
Batches of this medicine are being recalled from the market because of low levels of microbial contamination.
-
Etravirine: reports of severe hypersensitivity reactions
Cases of severe hypersensitivity syndromes, sometimes fatal, have been reported with etravirine.
-
Colchicine: extremely toxic in overdose
Reminder on risk of serious and fatal toxicity in overdose.
-
Introduction of the Traditional Herbal Registration Certification Mark
A certification mark has been designed and launched as an additional visible symbol.
-
Bisphosphonates: osteonecrosis of the jaw
All patients with cancer should have a dental check-up before bisphosphonate treatment.
-
Medical and non-medical prescribing: mixing medicines in clinical practice
Mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine.
-
Orciprenaline sulphate (Alupent): withdrawal due to unfavourable benefit-risk profile
Patients who require a liquid oral formulation of a β-agonist should be switched to a more-selective short-acting β2-agonist such as salbutamol or terbutaline.
-
Oseltamivir (Tamiflu): update to Patient Information Leaflet
There is no known interaction between oseltamivir and aspirin but aspirin must not be given to anyone younger than 16 year.
-
Vigabatrin for infantile spasms: risk of movement disorders and MRI abnormalities
If new movement disorders occur during treatment consider dose reduction or a gradual discontinuation of treatment in consultation with specialist advice.
-
Statins: updated adverse reaction information in patient leaflets
Healthcare professionals should be aware of the updated information so they can discuss it with new and existing patients.
-
Ceftriaxone (rocephin): incompatible with solutions containing calcium
Updated advice for healthcare professionals not to mix or infuse ceftriaxone with solutions containing calcium.
-
Smoking and smoking cessation: clinically significant interactions with commonly used medicines
Doses of theophylline, fluvoxamine, caffeine, coumarins including warfarin and the antipsychotics clozapine and olanzapine may have to be altered.
-
Human papillomavirus (HPV) immunisation programme - first-year safety review
The human papillomavirus (HPV) immunisation programme is now entering its second year and this article summarises the safety experience to date.
-
Varenicline and suicidal behaviour: cohort study provides some reassurance
The study found no clear evidence that varenicline was associated with an increased risk of fatal or non-fatal self-harm.
-
High-dose cyproterone acetate: potential risk of (multiple) meningiomas
Patients with existing meningioma or a history of meningioma must not be prescribed high-dose (≥25 mg per day) cyproterone acetate.
-
Over-the-counter painkillers containing codeine or dihydrocodeine
The tighter controls being introduced to minimise risk of overuse and or addiction of painkillers containing codeine or dihydrocodeine.
-
Insulin glargine: studies of possible cancer link
The European Medicines Agency has advised that no change in recommendations for use is required at present.
-
Pseudoephedrine and ephedrine: nasal decongestants
How to reduce risk of illicit use.
-
Impact of regulatory action taken by MHRA
How MHRA monitors the impact of regulatory action taken.
-
Herbal products: safety update
Important to inquire if patients are taking herbal medicines.
-
Rotigotine patches: lifting of prescribing restrictions
Cold-chain storage and distribution system now been fully implemented by manufacturer.
-
‘First Steps’ infant medicine feeder: recall due to overdose risk
Use of has led to serious paracetamol overdose in a 6-month-old infant.
-
Long-acting β-agonists: use in chronic obstructive pulmonary disease
Overall benefits of long-acting β-agonists (LABAs) in the treatment of chronic obstructive pulmonary disease (COPD) continue to outweigh any risks.
-
Clarification: ACE inhibitors and angiotensin II receptor antagonists
Use during breastfeeding
-
Mycophenolate mofetil: pure red cell aplasia
Healthcare professionals should consider a dose reduction or discontinuation of mycophenolate mofetil if patients develop pure red cell aplasia.
-
Abacavir: risk of myocardial infarction—update from epidemiological studies
Abacavir should be used in line with current treatment guidelines and with caution in patients with high cardiovascular risk factors.
-
Lancing devices for monitoring blood-glucose
How to ensure you use lancing devices correctly to prevent cross-infection such as hepatitis B.
-
Topical ketoprofen: reminder on risk of photo-sensitivity reactions
A reminder for those who use topical ketoprofen to avoid direct sunlight, ultraviolet rays, sunbeds or sunlamps.
-
Erlotinib: new safety information
New safety information for intensive monitoring of Erlotinib.
-
Oral salicylate gels: not for use in those younger than age 16 years
Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers.
-
Counterfeit medicines: what pharmacists should know
How pharmacists can prevent counterfeits reaching patients.
-
The Black Triangle Scheme (▼ or ▼*)
Continued monitoring of medicines with a black triangle status.
-
Antipsychotics: risk of venous thromboembolic events
Use of Antipsychotic may be associated with an increased risk of venous thromboembolic events.
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Chloral hydrate (Welldorm) and Triclofos
These medicines are not first-line options for insomnia.
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Non-steroidal anti-inflammatory drugs (NSAIDs): reminder on renal failure and impairment
You should take caution when you use NSAIDs in patients with renal impairment or are at risk.
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Aliskiren (Rasilez▼): risk of angioedema and renal dysfunction
Use of aliskiren can cause angioedema, a rare and serious side effect, and or acute renal failure.
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ACE inhibitors and angiotensin II receptor antagonists: recommendations on how to use for breastfeeding
Mothers who are breastfeeding should not take ACE inhibitors or angiotensin II receptor antagonists in the first few weeks after delivery.
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Antiepileptics: adverse effects on bone
Data suggests that long-term use of carbamazepine, phenytoin, primidone, and sodium valproate is associated with decreased bone mineral density that may lead to osteopenia, osteoporosis, and increased fractures.
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Methylthioninium chloride (methylene blue): update on central nervous system (CNS) toxicity
High intravenous doses of methylthioninium chloride (methylene blue) should be avoided for patients being treated with serotonergic antidepressants (eg, SSRIs, clomipramine, and venlafaxine).
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Off-label or unlicensed use of medicines: prescribers’ responsibilities
Healthcare professionals may have more responsibility to accurately prescribe an unlicensed medicine or an off-label medicine than when they prescribe a medicine within the terms of its licence.
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Over-the-counter cough and cold medicines for children
Advice on how to use cough and cold medicines safely for children under 12 years.
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Methylphenidate: safe and effective use to treat ADHD
Updated guidance to use methylphenidateto safely and effectively for attention deficit hyperactivity disorder (ADHD) in children of 6 years or older and adolescents.
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Info on progressive multifocal leukoencephalopathy (PML) from Yellow Card reports
Spontaneous reporting on the Yellow Card portal has provided important information in the identification of PML associated with some drugs.
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Exenatide (Byetta ▼): risk of severe pancreatitis and renal failure
There have been reports of necrotising and haemorrhagic pancreatitis in people taking exenatide some of which were fatal - stop exenatide treatment if pancreatitis is diagnosed.
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Atomoxetine: risk of psychotic or manic symptoms in children and adolescents
Atomoxetine is associated with treatment-emergent psychotic or manic symptoms in children and adolescents - consider stopping this if symptoms occur.
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Public perception of herbal medicines
In 2008 MHRA commissioned Ipsos MORI to research the public’s perception of herbal medicines, the findings may help doctors and pharmacists when considering how to advise patients.
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Toremifene (Fareston): risk of QT prolongation
Toremifene (fareston) is associated with a dose-dependent risk of QT prolongation.
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Piperacillin/tazobactam: compatibility of generics is different from brand leader (tazocin)
Generic piperacillin/tazobactam products have different compatibilities with other medicines compared with tazocin, raising a risk of serious medication errors.
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Temsirolimus: severe hypersensitivity reactions during infusion
Severe infusion-related hypersensitivity reactions have occurred in patients receiving temsirolimus.
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Norfloxacin: restricted use in urinary infections
The European Medicines Agency (EMA) has concluded that oral fluoroquinolone norfloxacin (Utinor) shouldn't be used to treat acute or chronic, complicated pyelonephritis.
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Nitrous oxide: neurological and haematological toxic effects
Toxic effects can occur with nitrous oxide especially with prolonged use.
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Ergot-derived dopamine agonists: risk of fibrotic reactions
New warnings and contraindications for ergot-derived dopamine agonists due to risk of fibrosis associated with chronic use.
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Central alerting system (CAS): access to urgent safety guidance
Use the central alerting system to view and search new alerts, as well as past alerts that were issued through the public health link and safety alert broadcast system.
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Serious and fatal overdose of fentanyl patches
MHRA has received reports of unintentional overdose of fentanyl due to dosing errors, accidental exposure, and exposure of the patch to a heat source.
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Recombinant human erythropoietins: treating anaemia in cancer
Patients with cancer who received recombinant human erythropoietins in clinical trials had an increased risk of tumour progression and reduced overall survival compared with study controls.
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Antiepileptics: risk of suicidal thoughts and behaviour
Antiepileptic treatment is associated with a small risk of suicidal thoughts and behaviour.
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Etoricoxib: prescribing to patients with high blood pressure
Do not prescribe etoricoxib to patients whose blood pressure is persistently above 140/90 mmHg and inadequately controlled.
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Bisphosphonates: atrial fibrillation
Clinical trial results suggest an increased risk of atrial fibrillation for zoledronic acid (Aclasta▼), pamidronic acid, and possibly for alendronic acid, although the balance-risk remains favourable for bisphosphonates.
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Inhaled medicines containing corticosteroid
Licensed doses and differences in potency between different inhaled corticosteroids; advice for use with spacer device.
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Ergot-derived dopamine agonists: risk of fibrosis
Do not prescribe ergots to patients who have had fibrosis in the heart, lungs, or abdomen.
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Enoxaparin (Clexane) contamination: latest information
Updated information on supply and clinical advice on enoxaparin (Clexane) pre-filled syringes, contaminated with over-sulphated-chondroitin sulphate (OSCS).
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Nicorandil: risk of gastrointestinal ulceration
Nicorandil is associated with a risk of gastrointestinal ulceration including perianal ulceration.
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Monitoring the safety of antiretroviral drugs
Healthcare professionals should monitor the use and safety of antiretroviral drugs for the treatment of HIV as they are advanced.
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Herbal medicines: new help available when advising patients about safe use
Most herbal medicines on the UK market are currently unlicensed products and it is difficult for consumers or healthcare professionals to identify which products are manufactured to acceptable standards with reliable product information.
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Hormonal contraceptives: cervical cancer
Latest evidence suggests long-term use of combined oral contraceptives or progestogen-only injectable contraceptives is associated with a small increased risk of cervical cancer.
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Combined oral contraceptives show they can prevent ovarian cancer
New study shows use of oral contraceptives reduces risk of ovarian cancer.
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Antidepressants: suicidal thoughts and behaviour
Summary report on the risk of suicidal thoughts and behaviour related to antidepressants.
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Injectable medicines for cosmetic procedures: supply and administration
Updated guidance on the supply and administration of Botox, Vistabel, Dysport, and other injectable medicines used in cosmetic procedures.
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Telbivudine and pegylated interferon: risk of peripheral neuropathy
Patients who take telbivudine and pegylated interferon are at increased risk of peripheral neuropathy and should stop taking both medicines if symptoms occur.
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Tazocin (piperacillin/tazobactam): new formulation
Tazocin (piperacillin/tazobactam) has been reformulated to meet European Pharmacopoeia requirements on particle size.
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Biosimilar products
A similar biological medicinal product (biosimilar) is a new biological product that has been developed to be similar to an existing biological product (“reference” product).
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Carisoprodol and meprobamate: risks outweigh benefits
Marketing authorisations for carisoprodol are to be suspended after a European review concluded that the risks of treatment outweigh the benefits.
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Herbal product: intensive body lotion with aloe vera contains steroids
MHRA has found samples of intensive body lotion with aloe vera (OSAS) to contain corticosteroid betamethasone.
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Review on long-acting β2 agonists for asthma
Long-acting β2 agonists (LABA) should only be prescribed in conjunction with inhaled corticosteroids for the treatment of moderate to severe asthma.
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Bivalirudin: risks associated with incorrect dose
Incorrect dosage of bivalirudin in percutaneous coronary intervention can lead to major adverse cardiac events.
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Paraffin-based treatments: risk of fire hazard
Paraffin based products such as white soft paraffin can set on fire easily.
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Statins: interactions, and updated advice for atorvastatin
Detailed recommendations for dose restrictions when used with some other drugs as interactions may increase the risk of adverse effects, or reduce the effectiveness of statin treatment.
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Oral anticancer medicines: risk of incorrect dosing
Advice for healthcare professionals on potentially fatal outcomes of oral anticancer medicines if they are not prescribed, dispensed or administered properly.
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Desmomelt (desmopressin): report incidents on yellow card portal
Healthcare professionals are encouraged to report all suspected adverse reactions (ADRs) on the yellow card porftal to melt formulations of desmopressin.
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ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy
Use in women who are planning pregnancy should be avoided unless absolutely necessary, in which case the potential risks and benefits should be discussed
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NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
Patients should use the lowest effective dose, and the shortest duration of treatment necessary to control symptoms.
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Recombinant human erythropoietins: new advice for prescribing
Over-correction of haemoglobin concentration may increase the risk of death and serious cardiovascular events in patients with chronic kidney disease; it may increase the risk of thrombosis and related complications in patients with cancer.
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Talc for pleurodesis: adverse effects
We have recently advised that talc preparations for pleurodesis are to be considered as medicinal products.
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Codeine: very rare risk of side-effects in breastfed babies
Breastfed babies might very rarely develop side-effects due to the presence of morphine in breast milk.
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Co-proxamol withdrawal: reminder to prescribers
Co-proxamol's phased withdrawal period lasts until the end of 2007 to enable patients to move to suitable alternatives.
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Herbal ingredient St John’s wort may interact with antiepileptics
Patients with epilepsy should not take products that contain St John’s wort as any antiepileptic medicine may interact with St John’s wort.
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Illegal herbal remedies containing Aristolochia: vigilance needed
MHRA continues to identify cases of herbal medicines, particularly traditional Chinese medicines, which contain illegal and toxic Aristolochia or aristolochic acids.
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Ecoflac infusion solutions: risk of air embolism
To avoid the risk of air embolism, these products should not be infused under pressure.
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Inhaled corticosteroids: pneumonia
Physicians should remain vigilant for pneumonia and other infections of the lower respiratory tract (ie, bronchitis) in patients with chronic obstructive pulmonary disease who are treated with inhaled products that contain steroids
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Botulinum toxin products: rare but serious risks
Products that contain botulinum toxin are associated with the risk of serious adverse reactions due to distant spread of toxin.
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Piroxicam: new restrictions, including specialist initiation
Systemic piroxicam should be initiated only by specialists as a second-line treatment for arthritis, with patients who currently take piroxicam reassessed at a routine appointment.
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Pneumovax II: tolerability of re-vaccination
Healthcare professionals should advise patients who need re-vaccination with Pneumovax II to expect a more intense reaction than after their first vaccination.
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Ketoprofen and ketorolac: gastrointestinal risk
Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.
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Lorazepam: reduction of recommended maximum daily dose
Maximum dose of lorazepam for short term, symptomatic treatment is 4 mg per day for severe, disabling anxiety, and 2 mg per day for severe, disabling insomnia
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Pabrinex: allergic reactions
Rare occurrence of serious allergic reactions should not preclude use of parenteral thiamine in patients who need treatment by this route of administration.
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Tibolone: benefit-risk balance
Increased risk of stroke in older women should be taken into account in prescribing decisions.
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Duloxetine: marketed as Cymbalta▼ and Yentreve▼ for different disorders
Patients should be assessed regularly due to reported cases of suicidal ideation and suicidal behaviour during treatment with duloxetine or shortly after stopping treatment.
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Corticosteroids: early psychiatric side-effects
Risk of early psychiatric side-effects is one of several important safety issues for healthcare professionals to discuss with patients and carers, who should seek urgent medical advice in the event of any worrying symptoms.
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Desmopressin nasal spray: removal of nocturnal enuresis indication
Nasal formulations of desmopressin are no longer indicated for primary nocturnal enuresis.
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Hormone-replacement therapy: updated advice
Before prescribing hormone-replacement therapy, healthcare professionals should consider carefully the potential benefits and risks for every woman
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α-1 adrenoreceptor antagonists: intraoperative floppy iris syndrome (IFIS)
Cataract surgeons should check past or current use of α-1 adrenoreceptor antagonists for prostatic hypertrophy before surgery.
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Linezolid: restricted indication
Linezolid is not active against infections caused by Gram-negative pathogens, and treatment should be started only after specialist microbiological advice.
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Dopamine agonists: pathological gambling, increased libido, and hypersexuality
Healthcare professionals should warn patients that compulsive behaviour with dopamine agonists may be dose-related.
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Isotretinoin for severe acne: who should prescribe it
Isotretinoin should only be prescribed by consultant dermatologist-led teams and dispensed only by a hospital pharmacy.
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Extraneal and products that contain (or are metabolised to) maltose, xylose, or galactose: false blood glucose readings
Patients who use products that contain maltose, xylose, or galactose should use glucose-specific monitors.
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Aspirin: not licensed for primary prevention of thrombotic vascular disease
In the UK, low-dose aspirin is licensed for prevention of thrombotic cerebrovascular or cardiovascular disease only in those who already have vascular disease—ie, secondary prevention.
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