The U.S. Food and Drug Administration (FDA) recently released a safety alert for women taking birth control pills with drospirenone. The reason: a possible risk of increased blood clots.
Most birth control pills contain two types of hormones, estrogen and progestin. The FDA described drospirenone as a type of female sex hormone called a progestin.
WebMD reported that the agency’s decision to investigate these birth control pills was based on two newly published studies. Those studies suggested an increased risk for blood clots may exist in women taking pills containing drospirenone, a synthetic version of the hormone progestin, as compared to women taking birth control pills that contain levonorgestrel, another version of progestin.
All hormonal oral contraception has a small risk of blood clots. But Time Magazine reported that the two studies, published in April, 2011 in the British Medical Journal, found women aged 15-44 taking drospirenone-containing birth control pills were two to three times more likely to develop blood clots that develop in the deep veins of the legs, than women using older pills containing the progestin levonorgestrel.
The Wall Street Journal reported that blood clots form inside a vein and are known as deep vein thrombosis, or DVT. The clots usually form in the lower leg or thigh, but can break loose and travel to other areas of the body such as the lungs, where they are called a pulmonary embolism, or PE.
The FDA released a list of drospirenone-containing products. These include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral.
Even though these two studies reported a higher risk of blood clots, other studies have not. Now the FDA is charged with evaluating the results from the conflicting results. Furthermore, the agency plans to review all available information on drospirenone-containing birth control pills. This will allow it to fully assess the risks and benefits associated with drospirenone.
The Wall Street Journal also reported that an FDA-commissioned study exploring the association of blood clots with hormonal contraception is in the process of being finalized and reviewed. The study involves more than 800,000 U.S. women and results are expected later this summer.
The official FDA recommendation is do not stop taking birth control even if it contains drospirenone without first consulting your doctor. Women who develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath should immediately contact a health care provider.
The FDA will continue to share all new safety information as it becomes available.
Sources:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm
http://women.webmd.com/news/20110602/fda-investigates-newer-birth-control-pills
http://online.wsj.com/article/SB10001424052702303657404576357683175203832.html?mod=googlenews_wsj
http://healthland.time.com/2011/06/02/a-common-hormone-in-birth-control-may-have-heightened-blood-clot-risk/
http://drugs-today.info/2011/06/do-birth-control-pills-containing-drospirenone-raise-blood-clot-risk-fda-orders-safety-review/
http://www.southbendtribune.com/features/momsmichiana/la-heb-birth-control-clot-20110601,0,2915597.story
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001189/
Reviewed June 7, 2011
Edited by Alison Stanton