January 29, 2013 | By Márcio Barra
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will review third and fourth generation combined oral contraceptives, under recent initiatives in France against these drugs. This comes as a request from France, and is noteworthy as it is the first time, since the implementation of the new Pharmacovigilance Regulation adopted back in 2010, that a Member State has requested the European Agency to provide a recommendation or re-evaluation of a drug.
The PRAC will review the available data on the contraceptives and evaluate if the current information on them is of quality and accurate. Information on this review will be published following the next week meeting of the Committee, on 4 to 7 February 2013.
This review follows growing media reports about venous thromboembolism (VTE or blood clots) due to use of these contraceptives. A notorious case even went to court, after a woman, Marion…
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DRUG REGULATORY AFFAIRS INTERNATIONAL 