Drospirene is a synthetic version of the female hormone, progesterone, or progestin.
The FDA reviewed recent studies and concluded that these types of birth controls may be linked to a higher risk of blood clots compared to other progestin-containing pills. The agency will add this information to the birth control labels.
The labels will warn that some epidemiologic studies reported as high as a three-fold increased risk of blood clots for products containing drospirene when compared to products containing levonorgesterel or other products, according to an FDA press release. The labels will also include a summary of previously released results of an FDA-funded study of the blood clot risks.