MHRA Drug Safety Update
July 2019
Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease
Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate.
https://www.gov.uk/drug-safety-update/febuxostat-adenuric-increased-risk-of-cardiovascular-death-and-all-cause-mortality-in-clinical-trial-in-patients-with-a-history-of-major-cardiovascular-disease
Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
https://www.gov.uk/drug-safety-update/tocilizumab-roactemra-rare-risk-of-serious-liver-injury-including-cases-requiring-transplantation
Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food
MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients taking 15 mg or 20 mg rivaroxaban on an empty stomach; remind patients to take 15 mg or 20 mg rivaroxaban tablets with food.
https://www.gov.uk/drug-safety-update/rivaroxaban-xarelto-reminder-that-15-mg-and-20-mg-tablets-should-be-taken-with-food
Letters and drug alerts sent to healthcare professionals in June 2019
Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regulated medicines supply chain during distribution. Other alerts were issued about paracetamol tablets, docetaxel injection, Baxter potassium-chloride-containing intravenous infusions, and Emerade adrenaline auto-injectors.
https://www.gov.uk/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-june-2019
Medical Device Alerts issued in June 2019
An alert was issued about Dialog+ haemodialysis machines.
https://www.gov.uk/drug-safety-update/medical-device-alerts-issued-in-june-2019
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