BETHESDA, MD 10 April 2012—Women who use oral contraceptives that contain the synthetic progestin drospirenone have a higher risk for blood clots than women whose contraceptive uses a different progestin, FDA announced today in a Drug Safety Communication.
FDA first announced its investigation of the association between drospirenone and the risk for blood clots last year.
The agency stated that the labeling for four contraceptive products—Beyaz, Safyral, Yasmin, and Yaz—will be revised to report that up to a three-fold increase in the risk of blood clots was reported in some epidemiologic studies in women who used a drospirenone-containing product instead of contraceptives with other progestins. Other studies did not find this increased risk among drospirenone users.
FDA also noted that it is unclear whether the blood clots reported among women taking a drospirenone-containing contraceptive were related to the product's use or had another cause.
But overall, the blood clot risk observed among women who used oral contraceptives was lower than the risk women face during pregnancy and in the postpartum period, according to FDA.
FDA has now completed its review of the issue.
According to the agency, 11 oral contraceptive products on the U.S. market contain drospirenone, and all are formulated in combination with ethinyl estradiol. Two of the products also contain levomefolate calcium.
Bayer HealthCare Pharmaceuticals today announced labeling changes for the company's drospirenone-containing combination oral contraceptive products.
According to Bayer, the revised labeling states that women are at greatest risk of a blood clot when they first start using an combination oral contraceptive product or when they restart the contraceptive regimen after a four-week or longer break.
FDA urged women to speak to a health care provider about their blood clot risk when choosing a contraceptive method.
Before prescribing a drospirenone-containing contraceptive, health care providers should consider the patient's risk for the development of blood clots, FDA stated.