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.

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.

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.

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).

Medical Device Alerts issued in June 2019

An alert was issued about Dialog+ haemodialysis machines.

Posted on the UK MHRA website on 17 July 2019