Desogestrel thromboembolism risk will be subject of FDA label review when U.K. studies are published.
Executive Summary
DESOGESTREL LABELING UPDATE TO ADDRESS BLOOD CLOT RISK is likely, FDA indicates in a Nov. 14 "Talk Paper" responding to three unpublished studies purported to show an increased risk of non-fatal venous thromboembolism with oral contraceptives containing desogestrel or gestodene. FDA intends to evaluate data on risk of arterial disease which may counterbalance the information on venous clots when labeling is reviewed. The blood clot information may contribute to a review of all OC labeling and relative risks between different generation products.