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  • Title: Venous thromboembolism and desogestrel- or gestodene-containing combination oral contraceptives: what are the facts?
    Journal: Contracept Rep; 1996 Apr; 7(1):3-6. PubMed ID: 12320047.
    Abstract:
    The UK's prescription drug regulatory agency warned the public and health care providers about the possible increased risk of venous thromboembolism (VTE) among users of the combined oral contraceptives (OCs) containing desogestrel or gestodene. Data from three large not-yet-published studies served as the basis for the warning. The studies found about a 2-fold increased risk of VTE for these OC users when compared to users of OCs with other progestins. Yet the observational studies are subject to inherent biases (e.g., hospitalized cases and selection bias), which may explain the increased risk. Assuming the increased risk to be true, the risk of VTE is still lower than that linked to pregnancy (30 vs. 60 VTE cases per 100,000). The risk of VTE for users of OCs containing older progestins is about 15 VTE cases and that among healthy, nonpregnant, nonusers is about 4 VTE cases. The mortality risk associated with VTE among users of OCs containing desogestrel or gestodene is 1-1.5 deaths/1 million woman-years. The US Food and Drug Administration has examined the data and has concluded that the risk is not high enough to justify switching to other OCs or stopping use of OCs containing desogestrel or gestodene. It recommends that users of the OCs in question discuss the OCs with their providers and make an informed choice based on the benefits and risks and individual preferences. It might consider changes in labeling, but not pulling the OCs off the market. In Germany, women aged less than 30 were temporarily advised not to begin use of desogestrel- or gestodene-containing OCs. Women using them were advised to continue their use, however. The European Union announced that bias or chance could account for the findings and thus did not recommend changes in prescribing desogestrel- or gestodene-containing OCs.
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