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donderdag 22 juni 2017

DrugSafetyUpdate: denosumab, brimonidine gel, pseudoephedrine and ephedrine, e-cigarettes…

GOV.UK

MHRA – Drug Safety Update

June 2017

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.

https://www.gov.uk/drug-safety-update/denosumab-prolia-xgeva-reports-of-osteonecrosis-of-the-external-auditory-canal

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.

https://www.gov.uk/drug-safety-update/brimonidine-gel-mirvaso-risk-of-systemic-cardiovascular-effects-not-to-be-applied-to-damaged-skin

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.

https://www.gov.uk/drug-safety-update/pseudoephedrine-and-ephedrine-regular-review-of-minimising-risk-of-misuse-in-the-uk

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).

https://www.gov.uk/drug-safety-update/e-cigarettes-and-refill-containers-e-liquids-report-suspected-side-effects-and-safety-concerns

Letters sent to healthcare professionals in May 2017

Letters were sent about Pharmalgen (Bee Venom and Wasp Venom) Initial kits, bendamustine (Levact), and ERWINASE.

https://www.gov.uk/drug-safety-update/letters-sent-to-healthcare-professionals-in-may-2017

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.

https://www.gov.uk/drug-safety-update/medical-device-alerts-issued-in-may-2017

Drug Safety Update is a monthly newsletter from the Medicines and Healthcare products Regulatory Agency (MHRA) and its independent advisor the Commission on Human Medicines.

Enquiries about this email should be sent to: email.support@mhra.gsi.gov.uk.

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