FDA Warns About Risks with Birth Control Pills Containing Drospirenone
The FDA has not reached a definitive conclusion nor recalled contraception containing the hormone drospirenone. But on September 26, 2011, it told consumers and physicians that it is officially reviewing its safety.
The FDA has not reached a definitive conclusion nor recalled contraception containing the hormone drospirenone. But on September 26, 2011, it told consumers and physicians that it is officially reviewing its safety.
Two 2011 studies that found a two to three times greater risk of venous thromboembolism events for women who use birth control pills that contain drospirenone than for those using pills that contain the hormone levonorgestrel.
(Parkin L, Sharples K, Hernandez RK, Jick SS. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ 2011; 340:d2139; and Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 2011; 340:d2151.)
Drospirenone-containing products include:
Ocella
Safyral
Syeda
Yasmin
Zarah
Beyaz
Gianvi
Loryna
Yaz
Drospirenone and ethinyl estradiol
The agency has scheduled an advisory committee meeting Dec. 8, 2011, to discuss the risks and benefits of birth control pills that contain drospirenone. Meanwhile, physicians are advised to let their patients know about possible risks and to report any adverse events.
Are you continuing to prescribe these drugs? Do you offer any special advice or warnings to patients?
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