FDA Charges Bayer with Withholding Data on Yasmin Blood Clot Risk
Bloomberg reports that in a document unsealed yesterday in federal court, David Kessler, commissioner of the Food and Drug Administration (FDA) under President Bush, states that Bayer withheld data showing that Yasmin increases the risk of blood clots in a 2004 safety report to the FDA.
Bayer was aware of “an increase in the U.S. reporting rate” for blood clots, and it was also aware of of “spontaneous reporting data” that signaled “a difference in the VTE [venous thromboembolism, blood clots occurring in veins which can travel to the heart or lungs] rates for Yasmin” and other birth control pills. However, Kessler says, “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”
Bayer currently faces over 10,000 Yaz and Yazmin lawsuits for injuries caused by their birth control pills. From 2004 to 2008, there are at least 50 reported deaths. Plaintiffs charge Bayer with negligence in warning patients of health risks, and with marketing Yaz and Yasmin for unapproved uses such as treating PMS and acne. One instance of Bayer’s aggressive off-label marketing campaign is their $450,000 contract with a well known women’s health blogger, Judith Reichman, who mentioned off-label benefits of Yaz in her book.
In light of the growing evidence that Yaz and other birth control drugs containing the synthetic hormone drospirenone may increase the risk of blood clots, the FDA may require new warning labels for these higher risk pills. On December 8, the FDA will hold a hearing on Yaz and Yasmin birth control to determine their safety and effectiveness.