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German court lifts OC prescription ban.


 A German court recently ruled in favor of a contraceptive manufacturer by lifting the ban against prescribing oral contraceptives (OCs) containing gestodene or desogestrel (so-called "third generation OCs") to first-time users under age 30. This ban had been imposed by the health regulatory agency, the defendants in the lawsuit. This ban was issued in response to a controversy initiated in 1995 when the British Committee on the Safety of Medicines cited an increased risk of venous thromboembolism with use of these OCs. In the US, no OCs are available containing gestodene, and only two formulations contain desogestrel. While the US Food and Drug Administration stated that the increased risk was not sufficient to warrant switching patients from third-generation OCs, many clinicians refrained from prescribing the drugs, especially to first-time users. Some US clinicians see the German Court's ruling as vindication for their continued support for the product and report fewer side effects and better lipid-neutral profiles in users of these OCs. A proportion of women will develop deep vein thrombosis upon initiation of OC use, and these women stop using OCs. The newer formulations may appear riskier because they attract more new users, but a recent reexamination of the data from one of the original studies that led to the ban indicates that second- and third-generation OCs are associated with an identical risk of venous thromboembolism.
