Yaz Product To Control Birth May Not Be Safe

On Thursday, a watchdog organization urged the FDA to have a new vote about the risk of blood clots caused by birth control pills after agency advisers learned that the agency has ties to pill manufacturers. In December, the FDA asked experts to talk about the safety of birth control pills that contain the ingredient drospirenone. The Bayer birth control pills Yasmin and Yaz contain the potentially harmful compound. The panel made the decision that the benefits of pregnancy prevention outweighed any risks of the development of blood clots. According to public and court documents, three of the 26 FDA advisers had financial or research ties to the Bayer Company.

A fourth adviser was connected to the producer of generic copies of Yaz, Barr Lab, which is now a part of the Teva Pharmaceuticals Company. All four advisers’ votes reflected their beliefs that the birth control pill’s benefits outweighed any possible risks, which according to the Project on Government Oversight means that the pills could possibly stay on the market. The FDA does not have any obligation to follow recommendations made by its advisers but it often does which leads to questions about who is providing the advice.

The Executive Director of POGO, Danielle Brian said that American consumers should be able to trust the FDA and have faith that the advisory boards make decisions based on scientific facts rather than industry influence. The group delivered a letter to the Commissioner of the FDA, Margaret Hamburg this week. The letter asked Hamburg to throw out the old vote and assemble a new advisory committee to review the pills’ safety.

One FDA study estimated that ten out of ever ten thousand women who took birth control pills that included drospirenone would develop a blood clot per year in comparison to the six in ten thousand women that take older contraceptive brands. A blood vessel clot can be fatal if it reaches the heart, lungs or brain.

Some consumer organizations have urged the FDA to remove the pills in question from the market, since women have so many other control birth products available to them. David Kessler, the former head of the FDA has said that Bayer did not reveal blood clot reports from the agency and failed to warn patients about possible safety problems. During the December meeting, FDA advisers said that the scientific proof was inconclusive regarding the higher rate of blood clot incidence, but they did recommend that a better safety label be placed on the pills. A safety label that included all possible side effects would be a step in the right direction although removal of the product would be even better.