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.
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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.