European Medicines Agency to review third- and fourth-generation combined oral contraceptives

Source: European Medicines Agency Area: News The European Medicines Agency (EMA) has been asked by France to review third- and fourth-generation combined oral contraceptives to determine whether there is a need to restrict the use of these medicines to women who cannot take other combined oral contraceptives. This request has been made as part of recent initiatives in France to reduce the use of these medicines in favour of using second-generation oral contraceptives.   It is well established that the risk of venous thromboembolism associated with use of the third- and fourth-generation contraceptives is higher than that for the first- and second-generation contraceptives, although the absolute risk is very small. Information about these risks is included in the relevant product information and has been continuously updated.   The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will be review the available data on this issue and will give an opinion as to whether the currently available product ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news