Yasmin and other drospirenone-containing oral contraceptives "may be associated" with an increased risk of blood clots, compared with oral contraceptives that contain other progestins, the Food and Drug Administration has concluded.
In a statement issued on April 10, the agency announced that the conclusion is based on its review of epidemiologic studies of the risk of venous thromboembolic events (VTEs) associated with combined oral contraceptives (COCs) that contain drospirenone, a synthetic form of progesterone, and that this information is being added to the labels of these products. The COCs that contain drospirenone as the progestin component are Yasmin (0.03 mg of ethinyl estradiol with 3 mg of drospirenone), approved in 2001, the first COC that contained drospirenone; Yaz (0.02 mg of ethinyl estradiol with 3 mg of drospirenone), approved in 2006; and Safyral and Beyaz, folate-containing versions of Yasmin and Yaz, respectively, which were approved in 2010. Some generic formulations also are available.
The conflicting results of numerous epidemiologic studies evaluating the VTE risk associated with these COCs were reviewed at a meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in December 2011. The panels voted 15-11 that the benefits of these products for preventing pregnancy outweighed their risks, and voted 21-5 that the labels for these products did not adequately reflect available information about their risk-benefit profile.
The labels will state that some of the studies found a threefold increased risk in VTEs associated with drospirenone-containing OCs, compared with those containing levonorgestrel or another progestin, while others found no increased risk, according to the FDA statement.
For example, the Yasmin label now includes the statement that based on the currently available information, "DRSP [drospirenone]-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a threefold increase. Before initiating use of Yasmin in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE."
The new information appears in the warnings and precautions section of the labels, not in the boxed warning.
The FDA statement adds that the risk of blood clots "is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period."
Serious adverse events associated with drospirenone-containing COCs should be reported online to the FDA’s MedWatch program or by phone at 800-332-1088.