EMA to review third- and fourth-generation combined OCs; France investigates Diane-35
The European Medicines Agency 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.
France has made this request amid recent initiatives to reduce the use of third- and fourth-generation combined oral contraceptives by French women in favor of using second-generation oral contraceptives.
It is well established that combined contraceptives carry a very rare risk of venous thromboembolism (VTE or blood clots). However, the absolute risk is very small (between 20 and 40 cases per 100,000 women in one year of use), and the risk differs between different generations of combined contraceptives, the EMA stated.
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