Former FDA Commissioner Says Bayer Yasmin Hid Blood Clot Risks

Bayer AG, the maker of the Yaz and Yasmin birth control pills, hid evidence pointing to a higher rate of blood clots among users of Yasmin, according to a former head of the U.S. Food & Drug Administration (FDA). In court documents submitted in Yaz and Yasmin lawsuits, David Kessler also said Bayer promoted Yasmin for unapproved uses, particularly for treatment of premenstrual syndrome.

According to an article published by Law360.com, Kessler charged in a 121-page expert report that Bayer had documented that Yasmin was 10 times more likely to cause serious side effects, including deep vein thrombosis (DVT), a dangerous type of blood clot, in an early draft of an August 2004 white paper. But when the paper was submitted to the FDA, the statement mentioning the increased DVT risk was omitted.

According to a Bloomberg News report, Kessler’s statement was one of five expert opinions released yesterday by lawyers representing former users of Bayer’s Yasmin family of contraceptives in thousands of personal injury lawsuits. The lawsuits are part of a consolidated litigation, the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100), currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois. The lawsuits allege that Bayer neglected to appropriately warn patients and doctors about increased health risks associated with the drugs.

According to Bloomberg, the 2004 white paper was produced by Bayer after the FDA had written the company in June 2003 expressing concern about the number of adverse events, including deaths, reported in Yasmin users. Of six deaths in the U.S., five had been reported to the agency after April 2, 2003. In its letter, the FDA stated that in light of the reports, “a change in Yasmin labeling and possibly additional actions are now warranted.”

Bayer’s white paper was intended to compare Yasmin to other oral contraceptives, covering multiple adverse events including venous thromboembolism (VTE) and pulmonary embolism (PT), Bloomberg said. While earlier drafts of the white paper noted higher risks for blood clots and other side effects among users of Yasmin, the final draft didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate.” Also omitted was an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said.

“Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA could be made,” Kessler said. “NDA” refers to the company’s new drug application, according to Bloomberg.

“These facts would impact the agency’s risk-benefit equation about the drug and whether it could be approved,” Kessler continued.

The FDA is currently reviewing the safety of Yaz and Yasmin, and has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for this Thursday to discuss those and similar birth control pills. However, according to Law360.com, the FDA has refused to accept Kessler’s report for the hearing, because it was submitted after the November 23 deadline for all written submissions.

“I think the American public would want to know why the FDA has refused to consider important safety information that Bayer did not consent to be released to the public or the FDA until after the submission deadline,” the attorney wrote to the FDA in his response, according to Law360.com.

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