MHRA – Drug Safety Update
Denosumab (Prolia, Xgeva▼): reports of osteonecrosis of the external auditory canal
Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
Brimonidine gel (Mirvaso): risk of systemic cardiovascular effects; not to be applied to damaged skin
Systemic cardiovascular effects including bradycardia, hypotension, and dizziness have been reported after application.
Pseudoephedrine and ephedrine: regular review of minimising risk of misuse in the UK
Sales restrictions introduced in 2008 continue to be successful in managing the risk of misuse of pseudoephedrine and ephedrine.
e-cigarettes and refill containers (e-liquids): report suspected side effects and safety concerns
Use the Yellow Card Reporting Scheme to support the safety of e-cigarettes and refill containers (e-liquids).
Letters sent to healthcare professionals in May 2017
Letters were sent about Pharmalgen (Bee Venom and Wasp Venom) Initial kits, bendamustine (Levact), and ERWINASE.
Medical Device Alerts issued in May 2017
Alerts were issued about LIFEPAK 1000 automatic external defibrillators, Mitroflow LX (sizes 19mm and 21mm) biological replacement pericardial aortic heart valves, and Accu-Chek Insight insulin pumps.