FDA Investigating Blood Clot Risk from Yaz Birth Control

Federal investigators have launched a safety review of Yaz, Yasmin, Beyaz and similar birth control pills, after several recent studies have suggested that the drugs carry a greatly increased risk of blood clots. 

On May 31, the FDA announced it was initiating a safety review that includes all oral contraceptives containing the new “fourth” generation progestin drospirenone; including Yaz, Yasmin, Beyaz, Safyral and generic equivalents.

The review was sparked by the findings of at least two studies that found that drospirenone-based birth control carried two to three times the risk of blood clots than some other pills.

The announcement also came just days after the European Medicines Agency officially determined that the side effects of Yaz, Yasmin and similar pills were associated with a higher risk of venous thromboembolism (VTE) [PDF] when compared to older levonorgestrel-containing pills and recommended that the labels be updated. Both the FDA and its European counterparts note that the overall risk of a blood clot is still small.

The studies that sparked the FDA review were published in the British Medical Journal, and determined that women taking Yaz and Yasmin were twice as likely to have a blood clot than women taking levonorgestrel-based pills. The FDA notes that some prior studies found no evidence of an increased blood clot risk.

The FDA announced that the goal of the Yaz and Yasmin safety review is to fully assess the risks and benefits of drospirenone-based drugs and that it will release new safety information to the public as it becomes available.

Drospirenone is a newer type of progestin that is usually 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.

Some experts say that drospirenone disrupts the body’s normal mechanism of regulating a balance between salt and water. This results in elevated potassium levels, known as hyperkalemia, which can cause potentially life-threatening heart problems and other health issues.

In addition to Yaz, Yasmin and Beyaz, drospirenone is also used in the brand name birth control pill Safyral, as well as generic Yasmin equivalents sold as Ocella, Syeda and Zarah, and generic Yaz equivalents sold as Gianvi and Loryna.

Bayer currently faces about 7,000 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, gallbladder disease and other serious injuries after using Yaz, Yasmin, Beyaz or other drospirenone birth control pills.