GOV.UK
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Daclizumab (Zinbryta▼): suspension and recall for safety reasons; review patients as soon as possible and start alternative therapy
The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, in patients with multiple sclerosis.
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Esmya (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users
Temporary safety measures are in place while an EU review investigates the link between cases of serious liver injury, including 4 cases requiring liver transplantation, and Esmya for uterine fibroids.
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Head lice eradication products: risk of serious burns if treated hair is exposed to open flames or other sources of ignition, eg, cigarettes
Pharmacists should tell people about the risk of fire when they discuss head lice eradication options.
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Confidential prescribing and patient safety reports on key indicators now available free for GPs
Confidential reports designed to help you improve the quality of your prescribing and patient safety are now available for practices that contribute to the MHRA’s Clinical Practice Research Datalink.
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Letters sent to healthcare professionals in February 2018
Letters were sent about ellaOne, ERWINASE, Eperzan▼, Ocaliva▼, Velcade, Esmya, and Bleo-Kyowa.
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Medical Device Alerts issued in February 2018
Alerts were recently issued about RUSCH rectal/pharyngeal temperature sensors and Aquilon nebulisers.
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Misoprostol vaginal delivery system (Mysodelle): reports of excessive uterine contractions (tachysystole) unresponsive to tocolytic treatment
Monitor patients closely and remove the vaginal delivery system immediately in cases of excessive or prolonged uterine contractions, at the onset of labour, or if there is clinical concern for mother or baby.
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Mycophenolate mofetil, mycophenolic acid: updated contraception advice for male patients
Mycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic.
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Gadolinium-containing contrast agents: Omniscan and iv Magnevist no longer authorised, MultiHance and Primovist for use only in liver imaging
Omniscan and intravenous Magnevist are now no longer authorised for use and a product recall of any existing unexpired stock is underway.
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Letters sent to healthcare professionals in January 2018
Letters were sent about Buccolam (midazolam), misoprostol vaginal delivery system (Mysodelle), noradrenaline, Relenza (zanamivir), mycophenolate mofetil/mycophenolic acid, Flolan, and Fludara.
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Medical Device Alerts issued in January 2018
Alerts were recently issued by MHRA about all Philips HeartStart MRx monitors/defibrillators and Boston Scientific pacemakers and CRT-P.
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Daclizumab (Zinbryta▼) and risk of severe liver injury: new restrictions to use and strengthened liver monitoring
The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are contraindicated or unsuitable.
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Recombinant human erythropoietins: very rare risk of severe cutaneous adverse reactions (SCARs)
Recombinant human erythropoietin (r-HuEPO) treatment has been associated with very rare cases of life-threatening severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
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Drug-name confusion: reminder to be vigilant for potential errors
Take particular care when prescribing or dispensing medicines that could be confused with others (ie, they sound-alike or look-alike).
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Co-dydramol: prescribe and dispense by strength to minimise risk of medication error
Previously co-dydramol (dihydrocodeine/paracetamol) was available only in the ratio 1:50 (co-dydramol 10/500 mg).
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Herbal medicines: report suspected adverse reactions to the Yellow Card Scheme
If an adverse reaction is suspected, ask patients whether they are taking any herbal medicines and discuss with them the importance of reporting this via the Yellow Card Scheme.
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Letters sent to healthcare professionals in December 2017
Letters were sent about cladribine (Litak and Leustat), radium-223-dichloride (Xofigo▼), and ERWINASE.
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Medical Device Alerts issued in December 2017
Alerts were recently issued about BD Alaris/Asena syringe pumps and Maxter Catheters nasogastric (NG) feeding tubes.
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Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents
A review has found that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-containing contrast agents (GdCAs).
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Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected
Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.
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Radium-223 dichloride (Xofigo▼): do not use in combination with abiraterone and prednisone/prednisolone, following clinical trial signal of increased risk of death and fractures
A European review has begun into the safety of radium-223 dichloride following an observed increase in the incidence of deaths and fractures in patients with chemotherapy-naive metastatic castration-resistant prostate cancer receiving radium-223 dichloride in combination with abiraterone acetate (Zytiga) and prednisone/prednisolone as part of a clinical trial.
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Eluxadoline (Truberzi▼): risk of pancreatitis; do not use in patients who have undergone cholecystectomy or in those with biliary disorders
Cases of pancreatitis, with or without sphincter of Oddi spasm, have been reported in patients taking eluxadoline.
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Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias.
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Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
Monitor patients closely for skin cancers.
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Letters sent to healthcare professionals in November 2017
Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
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Medical Device Alert issued in November 2017
An alert was recently issued about Oxoid ceftazidime antimicrobial susceptibility test discs.
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Gentamicin: potential for histamine-related adverse drug reactions with some batches
Some batches of gentamicin sulphate active pharmaceutical ingredient (API) used to manufacture gentamicin may contain higher than expected levels of histamine, which is a residual from the manufacturing process.
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Quinine: reminder of dose-dependent QT-prolonging effects; updated medicine interactions
Quinine has dose-dependent QT-interval-prolonging effects and should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.
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Oral tacrolimus products: reminder to prescribe and dispense by brand name only
Inadvertent switching between tacrolimus products has been associated with reports of toxicity and graft rejection.
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Support our second social media campaign for suspected adverse drug reactions
We are running a second social media campaign to promote the reporting of suspected adverse drug reactions (ADRs) to the Yellow Card Scheme in support of the ADR awareness week taking place 20-24 November 2017.
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Antiepileptic drugs: updated advice on switching between different manufacturers’ products
In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.
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Updates to Public Health England’s Green Book chapter on live attenuated vaccines
Further to our previous advice in 2016, Public Health England have updated their guidance about live vaccination of infants born to a mother who received immunosuppressive biological therapy during pregnancy.
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Letters sent to healthcare professionals in October 2017
A letter was sent about injectable methylprednisolone products containing lactose (Solu-Medrone 40 mg); do not use in patients allergic to cow’s milk proteins.
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Medical Device Alert issued in October 2017
An alert was issued about Alere HIV Combo professional HIV tests.
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Methylprednisolone injectable medicine containing lactose (Solu-Medrone 40 mg): do not use in patients with cows’ milk allergy
Solu-Medrone 40 mg may contain trace amounts of milk proteins.
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Gabapentin (Neurontin): risk of severe respiratory depression
Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines.
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Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido
Cases of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido, have been reported rarely in patients taking oral isotretinoin for severe acne.
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Clozapine: reminder of potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus
If constipation occurs during treatment with clozapine (Clozaril, Denzapine, Zaponex), it is vital that it is recognised and actively treated.
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Letters sent to healthcare professionals in September 2017
Letters were sent in September about Dacogen (decitabine), Eperzan▼(albiglutide), ERWINASE, ReoPro (abciximab), and recombinant human erythropoietins.
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Medical Device Alerts issued in September 2017
Alerts were recently issued about Accu-Chek insulin pumps, Astral lung ventilators, and IntelliVue patient monitors used with 12-lead ECG.
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Miconazole (Daktarin): over-the-counter oral gel contraindicated in patients taking warfarin
Patients taking warfarin should not use over-the-counter miconazole oral gel (Daktarin).
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Loperamide (Imodium): reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse
There have been reports of cardiac events including QT prolongation, torsades de pointes, and cardiac arrest in patients who have taken high or very high doses of loperamide as a drug of abuse or for self-treatment of opioid withdrawal.
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Letters sent to healthcare professionals in August 2017
Letters were sent about INOmax (nitric oxide) cylinders and triptorelin (Decapeptyl).
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Medical Device Alerts issued in August 2017
Alerts were issued about NovoPen Echo and NovoPen 5 insulin pens and BioMérieux antimicrobial susceptibility tests.
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Ibrutinib (Imbruvica▼): reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections
Temporarily discontinue ibrutinib in patients who develop symptoms suggestive of ventricular arrhythmia and assess benefit-risk before restarting therapy.
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Corticosteroids: rare risk of central serous chorioretinopathy with local as well as systemic administration
Central serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of corticosteroids.
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Adrenaline auto-injectors: updated advice after European review
It is recommended that 2 adrenaline auto-injectors are prescribed, which patients should carry at all times.
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Letters sent to healthcare professionals in July 2017
Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
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Medical Device Alerts issued in July 2017
An alert was recently issued about Prismaflex haemofiltration machines.
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Daclizumab (Zinbryta▼) and risk of severe liver injury: initiation in multiple sclerosis now restricted, promptly review patients already on treatment
While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment.
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