Risk of Venous Thromboembolism Not Higher With Drospirenone-Containing OCPs Compared to Other OCPs

The risk of venous thromboembolism (VTE) is low in women taking drospirenone-containing oral contraceptives (OCPs), according to Kanade Shinkai, MD, PhD, Associate Professor of Clinical Dermatology, University of California, San Francisco, at the 73rd Annual Meeting of the American Academy of Dermatology (AAD).

Drospirenone-containing OCPs, among other OCPs, have been used in women with acne as a form of therapy or as an adjunct to topical therapy. In April 2012, the US Food and Drug Administration concluded that drospirenone-containing OCPs may be associated with a higher risk for blood clots than other OCPs, leading to patient concerns and media attention about the risk of VTE.

The results of the International Active Surveillance Study of Women Taking Oral Contraceptives, published in Contraception in April 2014, indicated that the 24-day regimen of drospirenone-containing combined OCPs was associated with similar risks of VTE compared to 21-day regimens of drospirenone-containing combined OCPs, OCPs without drospirenone, and levonorgestrel-containing OCPs.

The study enrolled 85,109 women in 2285 study centers in the United States and 6 European countries. Participants were followed for 2 to 6 years. There were 3 main cohorts: new users of an extended 24-day regimen of drospirenone and ethinyl estradiol (DRSP24d), 21-day regimens of drospirenone-containing OCPs (DRSP21d), and nondrospirenone (OCPs without drospirenone). Venous thromboembolism was the main clinical outcome evaluated. DRSP24d, DRSP21d, nondrospirenone, and levonorgestrel-containing OCPs showed similar incidence rates of VTE. The VTE incidence rates were:

• DRSP24d: 7.2 VTE/10,000 woman-years

• DRSP21d: 9.4 VTE/10,000 woman-years

• Nondrospirenone: 9.6 VTE/10,000 woman-years

• Levonorgestrel-containing OCPs: 9.8 VTE/10,000 woman-years

“This study shows that there is not a higher risk [of VTE] in any 1 OCP,” reported Dr. Shinkai. “The risk is highest in those with known risk factors for hypercoagulability or family history.”

Patients taking drospirenone-containing OCPs for acne should be educated on the signs and symptoms of VTE. Patients also should be screened for a history or family history of stroke, VTE, or myocardial infarction.