Washington, DCAlmost exactly two years ago, an advisory panel for the US Food and Drug Administration (FDA) voted to keep Beyaz birth control and other, similar birth control on the market with stronger warnings. The advisory panel met because of concerns about Beyaz side effects - side effects that were linked to birth control that contained drospirenone. Despite concerns about health risks to young women, the side effects of Beyaz were reportedly not serious enough to remove the birth control from the market.
Prior to the advisory committee meeting, the FDA issued a report titled, “Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints.” The report examined the risk of cardiovascular problems - such as venous thromboembolism, myocardial infarction and ischemic stroke - in newer hormonal birth controls.
The study found that drosperinone was linked to an increased risk of venous thromboembolism compared with other combined hormonal contraceptive pills. But it noted that not every study has found such a link. Although the use of combined hormonal contraceptives is linked to an increased risk of venous thromboembolism, not every study has found that newer combined hormonal contraceptives - those that contain drospirenone - have a higher risk than older contraceptives.
Of the six studies cited in the report, four suggested an increased risk of venous thromboembolism associated with the use of birth control that contained drospirenone. Because of the uncertainty and contradictions in study findings, the FDA’s study set out to examine whether there was a link between the use of drospirenone and the risk of venous thromboembolism.
“The main findings of this study are that all use of the DRSP pill and each of the continuous exposure preparations, the NGMN [noreltgestromin/ethinyl estradiol transdermal] patch and the ETON [etonogestrel/estradiol] vaginal ring, are associated with an increased risk of VTE relative to the standard low-dose OCPs,” the report’s authors noted. Furthermore, drospirenone was associated with an increased risk of arterial thrombotic events - including acute myocardial infarction and ischemic stroke - in new users between the ages of 35 and 55 years.
Despite the seriousness of the adverse reactions, and despite there being alternatives to drospirenone-containing birth control available, the FDA advisory panel voted in 2011 to keep the newer birth control on the market, but with a more serious warning.
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