Theodoros & Rooth, P.C.

Stacking the FDA Deck in Birth Control Query

The phrase FDA-approved carries a great deal of weight based on the assumption that all decisions by the U.S. Food and Drug Administration (FDA) rely on rigorous clinical trials and convincing safety and efficacy evidence.

However, a report by the Washington Monthly about a December, 2011, FDA inquiry into the dangerous side effects associated with the popular birth control pills Yaz and Yasmin raises troubling questions. The advisory committee looked at reported injuries, including heart attacks, strokes, pulmonary embolism and deep vein thrombosis, and clinical trial results to evaluate whether the risk of blood clots outweighed the benefits of these contraceptive products.

The final vote 15 to 11 vote came down in favor of benefits, even though there is convincing evidence that drospirenone, the synthetic hormone used in these products, increases the chances of a blood clot. In fact, an internal document from Bayer acknowledged in 2004 that Yasmin posed a “several-fold” greater risk for blood clots compared with other oral contraceptives and had a 10 times greater incidence of serious side effects.

Unfortunately, this evidence was released after the submission deadline had expired, so the FDA advisory committee never saw it. Even more disturbing, six of the panelists, including the chairperson, had paid positions at Bayer as researchers, consultants and speakers. The FDA failed to issue waivers disclosing this conflict of interest.

It is impossible to know how an unbiased panel would have voted regarding the benefits and dangers of Yaz and Yasmin. Women who have been seriously injured and the families of the women who have died as a result of blood clots can file lawsuits against the Bayer, charging them with neglecting to issue adequate warnings about the health risks of these products. Contact a personal injury attorney for more information.