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Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury
The indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Although the temporary sus…
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Pregabalin (Lyrica): reports of severe respiratory depression
Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …
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Alkindi (hydrocortisone granules): risk of acute adrenal insufficiency in children when switching from hydrocortisone tablet formulations to granules
When children receiving replacement therapy for adrenal insufficiency are being switched from hydrocortisone tablets to Alkindi granules, parents or carers should be informed of the need to be extra vigilant for symptoms of …
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Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancy
Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.
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COVID-19 vaccines and medicines: updates for February 2021
A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 16 February 2021.
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Letters and drug alerts sent to healthcare professionals in January 2021
A summary of letters and drug alerts recently sent to healthcare professionals.
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Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review
A review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs by the Commission on Human Medicines has confirmed that lamotrigine (Lamictal) and levetiracetam (K…
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COVID-19 vaccines (Pfizer/BioNTech and COVID-19 Vaccine AstraZeneca): current advice
Recent advice from the MHRA on the COVID-19 vaccines authorised for use in the UK, including advice for people with allergies and for women during pregnancy and breastfeeding.
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Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia
The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy (PML) in patients with mild …
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Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis
Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster …
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SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
SSRIs and SNRIs are known to increase bleeding risks due to their effect on platelet function. Data from observational studies suggest that the use of SSRI/SNRI antidepressants during the month before delivery may resul…
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Aminoglycosides (gentamicin, amikacin, tobramycin, and neomycin): increased risk of deafness in patients with mitochondrial mutations
Evidence suggests an increased risk of aminoglycoside-associated ototoxicity in patients with mitochondrial mutations, including cases in which the patient’s aminoglycoside serum levels were within the recommended range. The…
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Letters and drug alerts sent to healthcare professionals in December 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk
Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk for heart valve regurgitation (incompetence).
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Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban
Erythromycin has been associated with events secondary to QT interval prolongation such as cardiac arrest and ventricular fibrillation. Erythromycin should not be given to patients with a history of QT interval prolongation…
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Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis
Updates have been made to the magnitude of the known risk of infantile hypertrophic pyloric stenosis following exposure to erythromycin in infancy as a result of new epidemiological data. The risk is particularly increased i…
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Letters and drug alerts sent to healthcare professionals in November 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy
Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment…
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Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing
Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome. Measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), a…
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Ferric carboxymaltose (Ferinject▼): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures
Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Re-evaluate ferric carboxymaltos…
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Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs
Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect.
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Isotretinoin (Roaccutane▼): contribute to expert review
A review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group due to concerns about the possible associat…
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Letters and drug alerts sent to healthcare professionals in October 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity
Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. All patients should be tested for DPD deficiency be…
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Flucytosine (Ancotil): new contraindication in patients with DPD deficiency
Flucytosine is a prodrug of 5-fluorouracil used to treat systemic yeast and fungal infections and can cause life-threatening and severe toxicity in patients with complete and partial dihydropyrimidine dehydrogenase (DPD) def…
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Niraparib (Zejula▼): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment
Increase the frequency of blood pressure monitoring to at least weekly for the first 2 months, and then monitor monthly for the first year and periodically thereafter during treatment, following recent reports of onset of se…
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Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): updated advice on increased risk of neural tube defects
Updated safety recommendations have been issued as part of the European review evaluating cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir. Evidence collec…
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Warfarin and other anticoagulants: monitoring of patients during the COVID-19 pandemic
Guidance has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic.
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Every report counts: report suspected adverse drug reactions and take part in #MedSafetyWeek (2–8 November 2020)
Remain vigilant for suspected adverse drug reactions and report them to the Yellow Card scheme. Show your support during #MedSafetyWeek on 2–8 November 2020 by sharing material on social media and discussing with colleagues …
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Letters and drug alerts sent to healthcare professionals in September 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Opioids: risk of dependence and addiction
New recommendations following a review of the risks of dependence and addiction associated with prolonged use of opioid medicines (opioids) for non-cancer pain. Before prescribing opioids, discuss with the patient the risks …
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Transdermal fentanyl patches for non-cancer pain: do not use in opioid-naive patients
Following a review of the risks associated with use of opioid medicines for non-cancer pain, the Commission on Human Medicines (CHM) has recommended that fentanyl transdermal patches are contraindicated in opioid-naive patie…
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Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing
In autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). New …
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Insulins (all types): risk of cutaneous amyloidosis at injection site
Cutaneous amyloidosis at the injection site has been reported in patients using insulin and this may affect glycaemic control. Remind patients to rotate injection sites within the same body region.
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Letters and drug alerts sent to healthcare professionals in August 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Clozapine and other antipsychotics: monitoring blood concentrations for toxicity
Monitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. Blood level monitoring of other antipsychotics for toxicity may also be helpful in certa…
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Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment
Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist re…
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Baricitinib (Olumiant▼): increased risk of diverticulitis, particularly in patients with risk factors
Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.
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Isotretinoin (Roaccutane▼): reminder of important risks and precautions
We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretino…
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Emollients and risk of severe and fatal burns: new resources available
We inform healthcare professionals of the recent campaign to promote awareness of the risk and new resources available to support safe use following previous advice to health and care professionals.
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Letters and drug alerts sent to healthcare professionals in July 2020
A summary of letters and drug alerts recently sent to healthcare professionals, including recommendations to reduce handling errors with leuprorelin-containing depot medicines.
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Medical Device Alerts issued in July 2020
A summary of Medical Device Alerts recently issued by the MHRA.
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Stimulant laxatives (bisacodyl, senna and sennosides, sodium picosulfate) available over-the-counter: new measures to support safe use
We have introduced pack size restrictions, revised recommended ages for use, and new safety warnings for over-the-counter stimulant laxatives (orally and rectally administered) following a national safety review. Advise pati…
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Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors. In patients who receive a systemic VEGF pa…
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Liposomal and lipid-complex formulations: name change to reduce medication errors
Make a clear distinction between liposomal, pegylated-liposomal, lipid-complex and conventional formulations when prescribing, dispensing, administering, and communicating about these medicines. Medicines with these formulat…
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Letters and drug alerts sent to healthcare professionals in June 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Medical Device Alerts issued in June 2020
A summary of Medical Device Alerts recently issued by the MHRA.
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Cyproterone acetate: new advice to minimise risk of meningioma
Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. Use of cyproterone is contraindicated in patients with previous or current meningioma (for all indications) and should only be considered…
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Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are a…
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Letters and drug alerts sent to healthcare professionals in May 2020
A summary of letters and drug alerts recently sent to healthcare professionals.