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www.fdanews.com/articles/91103-acvtivist-group-asks-fda-to-ban-newer-oral-contraceptives

ACVTIVIST GROUP ASKS FDA TO BAN NEWER ORAL CONTRACEPTIVES

February 14, 2007

Public Citizen has filed a petition asking the FDA to ban third-generation oral contraceptives containing desogestrel, saying the pills double the risk of blood clots compared with pills without the ingredient while not having any clinical benefit over older medications.

Birth control pills containing desogestrel were designed to reduce unwanted side effects such as acne and hair growth, which were associated with earlier birth control pills. The group cited several studies showing desogestrel increased the risk of blood clots, which can cause fatal pulmonary embolisms.

Third-generation pills have 30 cases of blood clots for every 100,000 users per year, while second-generation pills have only 15 cases for every 100,000 users per year, Public Citizen said.

Public Citizen accused the agency of knowing about the risk from desogestrel since 1995 and not acting on it sooner. The group cited a November 1995 statement in which the FDA said new studies indicated "about a two-fold increase" in the risk of blood clots associated with using products containing desogestrel.