Posted On: October 31, 2011 by Carey, Danis & Lowe, L.L.C.

FDA Finally Reviewing Yaz Safety Issues

It has been a little longer than two years since the British Medical Journal started publishing its first articles containing warnings to patients about taking certain birth control pills containing drosperinone (Yaz and Yasmin). Finally, the FDA has decided to jump on the bandwagon and properly review the safety concerns.

On December 8 of this year, the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee will be getting together for a joint meeting where committee members will watch presentations given by the pharmaceutical industry, advocates for patient safety, researchers and even patients. Each of the presentations will be showing whether oral contraceptives containing drosperinone like Yaz and Yasmin are safe and effective. They will also be trying to figure out if the warnings given to healthcare professionals and on the labels are good enough.

The FDA's hearing date was called together because of the recent, various studies which continue to show that oral contraceptives like Yaz and Yasmin increase the risk of blood clots that can lead to other conditions, including heart attacks, strokes, pulmonary emboli (PE), deep vein thrombosis (DVT) and death. The studies also show that these drugs are more dangerous than other oral contraceptives that don’t contain drosperinone.

Even the FDA’s own research shows that patients taking Yaz and Yasmin were twice as likely to develop blood clots as the women who took birth control pills that contained levonorgestrel. While it is wonderful that the FDA is finally making deeper inquiries into Yaz and Yasmin safety concerns, it has many people wondering why it took the regulators so long to do it. Right now consumers and patient safety advocates alike are hoping that the FDA will issue a recall of Yaz and Yasmin, but it is unlikely that it will happen.