FDA reviews safety of drospirenone for increased DVT, PE risk

June 17, 2011

FDA is assessing new information indicating an association between birth control pills containing the progestin hormone drospirenone and an increased risk of deep vein thrombosis and pulmonary embolus.

FDA is assessing new information indicating an association between birth control pills containing the progestin hormone drospirenone and an increased risk of deep vein thrombosis (DVT) and pulmonary embolus (PE).

The ongoing safety review follows 2 studies published recently in the BMJ reporting a risk of venous thromboembolic events (VTE) up to 2 to 3 times greater for women using oral contraceptives containing drospirenone than the risk associated with using pills containing levonorgestrel.

Though 4 previously published studies have addressed the risk of blood clots in women using birth control pills containing drospirenone, the findings have been conflicting, according to an FDA drug safety communication, and these studies are already described in the current labels for all drospirenone-containing birth control pills. Two postmarketing studies, conducted at the request of FDA or the European regulatory agencies, did not report any difference in risk of VTEs between oral contraceptives containing drospirenone and those containing levonorgestrel or other progestins. However, 2 studies in 2009 did report a higher risk of VTEs in women using drospirenone-containing pills than those using pills containing levonorgestrel, the communication stated.

The agency is reviewing all currently available information, including the 2 most recent studies as well as data from a large FDA-funded study designed to look at thrombotic and thromboembolic risks including VTE in a number of hormonal contraceptive products that included more than 800,000 US women and is currently being finalized. New safety information will be communicated as it becomes available, the announcement noted.

Meanwhile, FDA advised healthcare professionals to continue to follow the recommendations in the drug labels when prescribing oral contraceptive products that contain drospirenone; discuss the known benefits and potential risks of drospirenone-containing products with patients; and educate patients about the signs and symptoms of DVT and PE, and instruct them to contact their healthcare professional immediately if they develop any symptoms.

Adverse events, side effects, or quality problems can be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program online [www.fda.gov/MedWatch/report.htm]; by mailing in the postage-paid, pre-addressed Form FDA 3500 [www.fda.gov/MedWatch/getforms.htm]; by faxing 800-FDA-0178; or by phoning 800-332-1088.