FDA updates drospirenone-containing birth control pill labels to emphasize possible increased risk of blood clots in women

Drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills, according to recent FDA observational (epidemiologic) studies.

Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. Based on its review, FDA is adding information about the risk of blood clots to the labels of drospirenone-containing birth control pills, including drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets (Beyaz, Bayer), drospirenone/ethinyl estradiol/levomefolate calcium tablets (Safyral, Bayer), levomefolate calcium tablets and drospirenone/ethinyl estradiol (Yasmin, Bayer), and drospirenone/ethinyl estradiol (Yaz, Bayer).

CONTROVERSY ALREADY EXISTED

"While it is well-justified for FDA to now issue product labeling changes based upon review of this more recent epidemiologic data, it should also be noted that general risk of clotting still remains relatively low with all oral contraceptives, and epidemiologic evidence can be muddled by a wide array of confounding factors," Calabrese continued. "Nonetheless, providers should take heed in closely monitoring and evaluating these data and labeling changes for themselves and openly discussing the risks and benefits of various oral contraceptive options with their patients."

According to a Bayer press release, the updated United States labels state that combined oral contraceptives containing drospirenone may be associated with a higher risk of venous thromboembolism (VTE) than combined oral contraceptives containing levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a 3-fold increase. The labels state that before initiating use of drospirenone-containing combined oral contraceptives in a new combined oral contraceptive user or a woman who is switching from a contraceptive that does not contain drospirenone, consider the risks and benefits of a drospirenone-containing combined oral contraceptive in light of her risk of a VTE.

TALK ABOUT RISKS

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of combined oral contraceptives. The risk of VTE is highest during the first year of combined oral contraceptive use. The greatest risk of VTE is present after initially starting a combined oral contraceptive or restarting (following a 4-week or greater pill-free interval) the same or a different combined oral contraceptive.

The revised labels update information that there is a risk of VTE among all combined oral contraceptives, but that the risk of VTE associated with pregnancy is even greater than the risk associated with any combined oral contraceptive use, including drospirenone-containing combined oral contraceptives.

In 2011, Bayer HealthCare Pharmaceuticals updated labels for drospirenone-containing products in various countries, (eg, Europe, Canada, and Australia).