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maandag 24 juli 2017

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


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.


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.


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.


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).


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.


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.