New Warning for Beyaz Birth Control Pills

Washington, DCBeyaz birth control pills and other medications that contain the hormone drospirenone must now carry a warning that they may increase the risk of potentially fatal blood clots, according to the Food and Drug Administration (FDA).

WebMD Health News reported that drospirenone is a synthetic version of the female sex hormone progesterone. Birth control pills that contain the hormone include Bayer Healthcare Pharmaceutical's Beyaz, Safyral, Yasmin and Yaz brands, as well as a series of other, less known versions of the medication.

According to the news outlet, the new action is the result of an extensive review of literature regarding the drugs and the potential side effects that have been reported by women across the US. The FDA noted that manufacturers must add information to the product labels of the various medications about studies that note the connection between the pills and an increased risk of blood clots.

"The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills," the FDA added.

Each of the nine pills that were in question will now carry a new warning label that highlights the increased risk, despite the findings that not all of the medications may be primarily responsible for the danger.

MedPage Today reported that Beyaz and Safyral also contain 0.451mg of levomefolate calcium, along with 3mg of drospirenone and either 0.02 or 0.03mg of ethinyl estradiol. This combination has been seen to increase the risk, but the FDA did not say that it definitely led to a rise in the danger due to the lack of entirely conclusive data.

According to the news outlet, the FDA noted, the risk of clotting while using these products still appears to be lower than thrombosis risk during pregnancy and in the immediate postpartum period. The data was available last year, but the agency had to wait until an advisory committee did an extensive study of the findings.