Drospirenone-Containing Birth Control Pills
April 12, 2012
After completing a review of recent observational studies, FDA concluded that oral contraceptives containing drospirenone (a synthetic version of progesterone) may be associated with increased risk of blood clots compared to products containing other progestins. The studies showed varying degrees of increased risk of blood clots ranging from no increased risk to a 3-fold higher risk. The actual risk of developing blood clots with drospirenone is not known.
FDA is updating the product labels of birth control pills containing drospirenone (ie., Yaz, Gianvi, Loryna, Yasmin, Ocella, Syeda, Zarah, Beyaz, Safyral). The new labeling will include information on the results of the observational studies and the results of a previously released FDA funded study regarding increased risk of blood clots.
Evaluate women for risk factors for developing blood clots when choosing an oral contraceptive based on patient risk factors. Assess whether the possible increased risk of blood clots associated with drospirenone outweighs the benefits.
Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
Additional information is available at the following links:
- FDA MedWatch
- Drug Safety Communication
- Updated Questions and Answers Surrounding Drospirenone:
- Drospirenone-Containing Birth Control Pills - Ongoing Safety Review for Increased Risk of Venous Thromboembolic Events
April 12, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.