FDA Reviews Drospirenone for VTE Risk

May 31, 2011 — The US Food and Drug Administration (FDA) is reviewing the safety of oral contraceptive pills that contain drospirenone to evaluate the risk for venous thromboembolism (VTE) associated with these products, the agency announced today.

Concerns about the safety of drospirenone with respect to VTE risk were raised in 2 recent articles published online April 21 in the BMJ. These studies showed a 2- to 3-fold greater risk for VTEs in women using oral contraceptives containing drospirenone compared with those using contraceptives containing levonorgestrel. Earlier studies had shown mixed results.

"FDA is currently reviewing the two most recent studies and will be looking at all currently available information to assess whether there is a greater risk of VTE in women using oral contraceptives containing drospirenone," the FDA said in a news release. "Data from an additional, large, FDA-funded study on hormonal contraceptives is also being finalized and reviewed," they note.

The FDA-funded ongoing study involves more than 800,000 women and will further assess thrombotic and thromboembolic risks, such as VTE, associated with various contraceptives. Results from the study are expected later this summer.

According to the FDA, the European Medicines Agency (EMA) announced on May 27 that "it is updating the product information on oral contraceptives containing drospirenone and ethinyl estradiol regarding the risk of venous thromboembolism after review of all available data, including the same newly published data FDA is reviewing."

The FDA recommends that healthcare professionals continue to follow the recommendations on drug labels when prescribing oral contraceptive products that contain drospirenone. In addition, clinicians should discuss the known benefits and potential risks of drospirenone-containing products with patients and educate them about the signs and symptoms of VTE, a term that incorporates both deep vein thrombosis and pulmonary embolism.

Patients who smoke or are older than age 35 years should not take combination oral contraceptives because of increased risk for cardiovascular events, including VTE.

Drospirenone is a progestin found in combination with ethinyl estradiol in products with the following brand names: Beyaz, Drospirenone and ethinyl estradiol, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

Adverse events related to drospirenone-containing products should be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-332-1088, by fax at 1-800-332-1078, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20857.

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