In a victory for consumers, Yaz, Yasmin, BeYaz, Ocella and other drospirenone-containing birth control pills will finally have to announce their increased risk of blood clots.
The FDA is requiring makers of the new-generation of birth control pills to add warning labels to the prescription medications, since the risk is greater than among older pills that contain only estrogen or progesterone.
An independent study conducted by the FDA found that while even though all birth controls increase a woman’s chances of developing a blood clot, the risk is much higher from pills containing drospirenone, or DRSP. As many as 10 in 10,000 women taking pills with DRSP would get a blood clot per year, according to the FDA.
This announcement is welcomed by many, especially by the thousands of U.S. women who have suffered blood clots as a direct result of taking Yaz, Yasmin and Ocella. Many of these otherwise healthy young women have filed suit against Bayer AG, the maker of Yaz, and the lawsuits have been consolidated into Multi-District Litigation under the Honorable David J. Herndon in the United States District Court, Southern District of Illinois.
"The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products ... whereas other epidemiological studies found no additional risk," the FDA said in a statement.