FDA mandates additional warning labels for synthetic hormone used in birth control

In the past, hormonal birth control—the pill, for example—contained natural hormones, most commonly estrogen and progestin. Hormonal contraception prevents pregnancy by using these hormones, in essence, to trick the body into behaving as though it is already pregnant; as a result, ovulation does not occur.

Anyone who has taken birth control pills, or used any of the various other methods of hormone delivery, should know that side effects include an elevated risk of blood clots. Blood clots are a potentially lethal mass of coagulated blood that can choke off blood vessels and deprive tissue of oxygen. Consequences can include heart attack and stroke—tissue death in the heart and brain, respectively.

More recently, popular birth control medications, such as Yaz and Yasmin, contain the synthetic hormone drospirenone. Now, the Food and Drug Administration has acknowledged multiple studies demonstrating that drospirenone increases the chance of blood clot formation. And the FDA’s own research shows that, on average, 10 in 10,000 women taking medication containing drospirenone will develop blood clots each year; the number falls to six women in 10,000 in the case of medications that do not contain the synthetic hormone.

According to the Reuters article, the FDA voted in favor of revising medications’ labeling in order to clarify the risks. However, despite pressure from watchdog organizations and women’s advocacy groups to pull medications like Yaz and Yasmin off the shelves, the FDA refused to take any further steps to protect consumers.

The FDA cited additional research that downplayed the higher risk of blood clots in defending its decision not to pursue the issue beyond the labeling changes. However, doubt has been cast on the integrity of that research by the Project on Government Oversight, a watchdog group that found prior ties between four FDA advisers and companies that manufacture products containing drospirenone. The FDA countered by stating that the law does not preclude those with previous links to industry from working for the FDA.

Complicating matters further is the discovery, made by women’s advocacy groups investigating the situation, that the studies cited by the FDA as proof of drospirenone’s safety were in fact funded by the pharmaceutical industry.

The full report can be found here.