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The European Medicine Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded three reviews into drug safety at its February meeting.
The PRAC completed reviews into: Tysabri (natalizumab), a multiple sclerosis medicine; fusafungine nose and mouth sprays, which are used to treat upper airway infections; and SGLT2 inhibitors, a class of type 2 diabetes medicines.
The Committee provided updated recommendations regarding the risk of the rare brain infection progressive multifocal leukoencephalopathy (PML) with natalizumab. PML is a rare and very serious brain infection caused by John Cunningham virus. The Committee’s new advice aims to help early detection of PML and improve patients’ outcomes, and minimise the risk of the brain infection.
PRAC also recommended revoking the authorisation of fusafungine nose and mouth sprays, meaning they can no longer be marketed in the UK. The PRAC concluded that the benefits of fusafungine did not outweigh its risks, particularly the risk of serious allergic reactions. Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).
Finally, the PRAC finalised a review of SGLT2 inhibitors and has made recommendations to minimise the risk of diabetic ketoacidosis. Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors for type 2 diabetes. There are currently three SGLT2 inhibitors authorised in the EU – canagliflozin, dapagliflozin and empagliflozin.
For more information visit http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/02/news_detail_002468.jsp&mid=WC0b01ac058004d5c1