Bayer HealthCare, a subgroup of Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK), said the company and U.S. Food and Drug Administration, or FDA, have agreed to update the labels for its drospirenone-containing combined oral contraceptives, or COCs, in United States.
The updated labels in the U.S. include additional information from recently published studies evaluating the risk of venous thromboembolism (blood clots) in women taking drospirenone-containing COCs. Mainly, the new U.S. labels state that COCs containing drospirenone may be associated with a higher risk of venous thromboembolism, or VTE, than COCs containing levonorgestrel or some other progestins, Bayer HealthCare noted.
Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. The U.S. labels state that before initiating use of drospirenone-containing COCs in a new COC user or a woman who is switching from a contraceptive that does not contain drospirenone, consider the risks and benefits of a drospirenone containing COC in light of her risk of a VTE.
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