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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices
Reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term …
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Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)
Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic.
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Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
Guidance has been published about thalidomide, lenalidomide, and pomalidomide and the use of remote consultations and home pregnancy testing for patients taking them during COVID-19.
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Letters and drug alerts sent to healthcare professionals in April 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Coronavirus (COVID-19): latest guidance for medicines safety
Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme.
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Letters and drug alerts sent to healthcare professionals in March 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Esmya (ulipristal acetate): suspension of the licence due to risk of serious liver injury
Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment.
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Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
Caution should be used in patients with known risk factors for venous thromboembolism in addition to the underlying disease.
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Baricitinib (Olumiant▼): risk of venous thromboembolism
Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur.
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SGLT2 inhibitors: monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness
SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine.
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Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression
Benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time.
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Letters and drug alerts sent to healthcare professionals in February 2020
Letters were sent on Typhim Vi vaccines, Mepact (mifamurtide), and Xeljanz (tofacitinib) and an alert issued to recall Emerade 150 microgram adrenaline pens.
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Medical Device Alerts issued in February 2020
Alerts were issued about CME T34 and T34L (T60) ambulatory syringe pumps, Cardinal Health tympanic thermometers, t:slim X2 insulin pump, and Mavidon skin preparation electrode gels.
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Ingenol mebutate gel (Picato▼): suspension of the licence due to risk of skin malignancy
Stop prescribing Picato and consider other treatment options for actinic keratosis as appropriate.
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Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions
A review of the benefits and risks of alemtuzumab (including fatal reactions) in the treatment of multiple sclerosis has now concluded and recommended a revised indication, additional contraindications, and strengthened moni…
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Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials
In January 2020, healthcare professionals received updated educational materials to support the valproate pregnancy prevention programme.
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Nexplanon (etonogestrel) contraceptive implants: new insertion site to reduce rare risk of neurovascular injury and implant migration
Amended advice on the insertion site for Nexplanon contraceptive implants following concerns regarding reports of neurovascular injury and implants migrating to the vasculature (including the pulmonary artery).