FDA will review risk of oral contraceptives containing drospirenone

June 9, 2011

FDA has announced that it will review the safety of oral contraceptives (OCs) containing the progestin drospirenone after 2 recent studies in the British Medical Journal (2011;340:d2139 and 2011;340:d2151) suggested that they might cause more blood clots than birth control pills containing levonorgestrel.

FDA has announced that it will review the safety of oral contraceptives (OCs) containing the progestin drospirenone after 2 recent studies in the British Medical Journal (2011;340:d2139 and 2011;340:d2151) suggested that they might cause more blood clots than birth control pills containing levonorgestrel.

The studies reported a 2- to 3-fold higher risk of venous thromboembolic events (including deep vein thrombosis and pulmonary embolism) among women using OCs with drospirenone compared with levonorgestrel. Previous studies of blood clots associated with drospirenone produced conflicting findings. FDA has commissioned an 800,000-person study to examine the risks of drospirenone OCs and expects to have results later this year.

Drospirenone is found in OCs marketed under the brand names Beyaz, Safyral, Yaz (generics Gianvi and Loryna), and Yasmin (generics Ocella, Syeda, and Zarah). In addition to contraception, the pills are used to treat moderate acne and premenstrual dysphoric disorder, and to increase folate levels in women using oral contraceptives for birth control.