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maandag 24 juli 2017

DrugSafetyUpdate: Daclizumab and risk of liver injury; bendamustine; nivolumab; pembrolizumab…

GOV.UK

MHRA – Drug Safety Update

June 2017

Daclizumab (Zinbryta▼) and risk of severe liver injury: initiation in multiple sclerosis now restricted, promptly review patients already on treatment

While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment.

https://www.gov.uk/drug-safety-update/daclizumab-zinbryta-and-risk-of-severe-liver-injury-initiation-in-multiple-sclerosis-now-restricted-promptly-review-patients-already-on-treatment

Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation

Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications.

https://www.gov.uk/drug-safety-update/bendamustine-levact-increased-mortality-observed-in-recent-clinical-studies-in-off-label-use-monitor-for-opportunistic-infections-hepatitis-b-reactivation

Nivolumab (Opdivo▼), pembrolizumab (Keytruda▼): reports of organ transplant rejection

There have been reports of rejection of solid organ transplants in patients treated with nivolumab or pembrolizumab.

https://www.gov.uk/drug-safety-update/nivolumab-opdivo-pembrolizumab-keytruda-reports-of-organ-transplant-rejection

Letters sent to healthcare professionals in June 2017

Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).

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

Medical Device Alerts issued in June 2017

Alerts were recently issued about high concentration oxygen masks, metal-on-metal (MoM) hip replacements, and BVM (Bag-Valve-Mask) manual resuscitation systems.

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