European Medicines Agency starts safety review of third and fourth generation combined contraceptives

Source: European Medicines Agency (EMA) Area: News The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has formally started a review of all combined hormonal contraceptives authorised in the EU that contain third or fourth generation progestogens, including chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin and norgestimate.   As reported previously on NeLM, this review has been initiated at the request of the French medicines regulatory agency (ANSM) due to concerns about the risk of venous thromboembolism (VTE). Previous EMA reviews of combined oral contraceptives concluded that that their absolute risk of VTE is low and extensive information on the risk and its management is included in their product information.   The PRAC will review all available data on the risk of VTE with these contraceptives and issue an opinion on whether any changes are needed to their prescribing advice across the EU. The review will also ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news