FDA warns of elevated blood clot risk in Yaz birth control pills

Two new studies showing an increased risk in venous thromboembolism (VTE), or blood clots in the lungs, in women who use Yaz birth control pills and oral contraceptives with similar hormone formulations, has resulted in a special drug safety notification from the Food and Drug Administration (FDA). Yaz, made by Bayer, contains the progestin drospirenone. The same hormone is used in Bayer’s Yasmin, Beyaz and Safyral, as well as generics such as Ocella, Gianvi, Loryna, Syeda, and Zarah.

The studies referenced by the FDA looked at VTE rates in women using birth control pills containing drospirenone compared with women taking pills containing levonorgestrel. Data showed that the risk for venous thromboembolism, or pulmonary embolism, is as much as two to three times greater with drospirenone-containing pills than with levonorgestrel-containing pills.

Bayer launched its blockbuster birth control pill Yaz with a huge marketing campaign that claimed it could conquer symptoms of premenstrual syndrome and clear up acne. The FDA fined Bayer for overstating the benefits of the drug and downplaying the risks, including the risk for blood clots.

Women began asking their doctors for Yaz by name, making it the most prescribed birth control pill in the country. The success of Yaz was only slightly hampered by a series of ads Bayer was forced by the FDA to run that clearly stated the risks associated with the pill. It wasn’t until reports of deaths and serious injuries in women who used Yaz that the public began to take notice.

Bayer has defended its oral contraceptives, arguing they are no more dangerous than other birth control pills. The new studies suggest otherwise. Bayer now faces thousands of lawsuits from women and their families who say they were not adequately warned of the risks associated with the pills, including blood clots (including VTE), heart attacks, strokes and sudden death.

The FDA recommends women who have questions about their oral contraception contact their doctors. If they experience any of the following symptoms of VTE to seek medical help immediately – persistent leg pain, severe chest pain, sudden shortness of breath.

Women who smoke and are older than 35 years of age should not take combination birth control pills because they increase the risk of serious cardiovascular events, including blood clots.

Source: FDA