Yasmin, Yaz Blood Clot Concerns To Be Reviewed by FDA Panel

A federally-funded study suggests that side effects of Yaz and Yasmin may carry a 150% increased risk of blood clots over other forms of birth control, and federal regulators have called for a panel of experts to review the safety of the popular birth control pills.

The FDA announced on Monday that it will hold a joint meeting of its Reproductive Health Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee on December 8, 2011, to discuss the risks and benefits of Yaz, Yasmin and other oral birth control pills using the progestin drospirenone.

The meeting was called after the FDA’s own Yaz safety review failed to reach a conclusion, but found enough evidence of health risks to be concerned. That review is ongoing.

FDA reviewers examined two studies from this year that looked at the side effects of drospirenone-based birth control, and the regulatory agency is also looking at the preliminary results from a study the FDA itself funded. That study suggests that the risk of blood clots with Yaz and Yasmin may be increased 1.5 times over other pills. The FDA has analyzed six studies in all, which the agency said often give conflicting information.

The advisory committees will meet and look at the evidence and then make recommendations to the FDA about any regulatory steps that may be necessary to protect the consumers from the potential risk of blood clots. While the recommendations are not binding, the FDA often bases its decisions off its advisory committees’ advice.

Drospirenone is a newer type of progestin that is used in combination oral contraceptives that also include estrogen. It was originally introduced by Berlex Laboratories in Yasmin. Once Berlex was acquired by Bayer Healthcare an updated version of Yasmin was introduced called Yaz. More recently, Bayer introduced a third version, marketed as Beyaz, which includes a folate supplement. Generic versions of Yaz and Yasmin are also now available from other manufacturers.

Bayer currently faces thousands of Yaz lawsuits, Yasmin lawsuits and Beyaz lawsuits, which allege that the drug maker has failed to adequately warn about the increased risk of health problems associated with the birth control pills.

The complaints have been filed on behalf of women who have suffered heart attacks, strokes, pulmonary embolism, deep vein thrombosis and other serious blood clot-related injuries, which they allege may have been prevented if more adequate information about the Yasmin and Yaz blood clot risk had been provided.