Stronger Yaz, Yasmin Blood Clot Warnings May be Warranted, FDA Says

Yaz, Yasmin and similar birth control pills could soon bear stronger warnings regarding their association with a higher risk of blood clots. According to a report from Reuters, U.S. Food & Drug Administration (FDA) reviewers said in a report released yesterday that the evidence linking oral contraceptives containing the synthetic progestin, drospirenone, to blood clots was conflicting, but could not be ruled out. As such, a stronger warning label for Yaz, Yasmin and other drospirenone pills may be warranted.

The FDA is currently reviewing the safety of drospirenone-containing birth control pills, and tomorrow, the agency’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will hold a joint meeting to vote on whether or not the drugs need stricter warning labels. In the meantime, agency reviewers have been pouring over studies that compare drospirenone contraceptives with pills that contain an older type of progestin.

Last month, the FDA reported that its own study found that women who use drospirenone pills were 75 percent more likely to experience clots compared to those taking other oral contraceptives. According to Reuters, the risk was especially high in women younger than 35, who were taking Yasmin. The FDA-funded study involved the medical histories of more than 800,000 American women, all of whom were on some type of birth control between 2001 and 2008.

“Because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility,” the FDA reviewers said in their report, according to Reuters.

As we reported yesterday, in court documents unsealed on Monday, former FDA commissioner David Kessler accused Bayer AG, the maker of Yaz and Yasmin, of hiding evidence pointing to a higher rate of blood clots among users of Yasmin from the agency.

“Bayer violated its duties under FDA regulations and state law by selectively presenting data as to [blood clotting] events,” Kessler said in the documents, citing studies that Bayer itself conducted.

Kessler is expected to testify as an expert witness on behalf of plaintiffs who have thousands of lawsuits pending against Bayer in a consolidated litigation underway in Illinois federal court. The lawsuits allege that Bayer neglected to appropriately warn patients and doctors about increased health risks associated with the drugs.

According to a report from the Associated Press, Yasmin, approved in 2001 was the first birth control pill to use drospirenone. Yaz, a reformulated version of the drug, was launched by Bayer in 2006, and was also approved to treat mild to moderate acne and premenstrual dysphoric disorder (PMDD). Backed by an aggressive marketing campaign, Yaz soon became the best-selling birth control pill in the U.S.

But in October 2008, the FDA issued a warning letter to Bayer over two Yaz commercials that the agency said overstated the drug’s efficacy, minimized its serious risks, and promoted it for conditions for which the drug is not approved. Bayer stopped running the commercials, and agreed to launch a corrective advertising campaign. In the wake of that campaign, sales of Yaz plummeted 50 percent, according to the Associated Press. Yaz now ranks fourth among contraceptive pills sold in the U.S., the Associated Press said.

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