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Former FDA Head Says Bayer Hid Yasmin Blood Clot Risk

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The former head of the U.S. Food & Drug Administration (FDA) says Bayer hid controversial birth control, Yasmin’s, blood clot risks.

A growing body of research has revealed that an increased risk of dangerous blood clots—venous thromboembolisms (VTEs)—have been linked to use of Yaz, Yasmin, and other drospirenone-containing contraceptives. Last month, the FDA issued a warning concerning drospiernone-containing oral contraceptives and stated that these drugs increase blood clot risks by 74% when compared to older birth control pills.

Health issues linked to Yasmin and Yaz include stroke, deep vein thrombosis, pulmonary embolism, heart attack, and gall bladder disease.

Now, according to Bloomberg News, former FDA commissioner, David Kessler, has said that a Bayer AG unit hid information from U.S. regulators about its company’s research findings that discussed increased blood clots in people taking Yasmin. In a just-unsealed document—opened in federal court in Illinois—Kessler said that Bayer did not include a 2004 analysis of a Yasmin safety review provided to the FDA “that demonstrated an increase in the U.S. reporting rate” for VTEs or clots, Bloomberg News explained.

Also, the report was submitted with the exclusion of a prior draft opinion authored by company researchers that stated that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” versus other oral contraceptives, said Kessler, quoting the draft, wrote Bloomberg News. Kessler continued, saying, “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.” Kessler also touted Yasmin for unapproved uses, particularly for treatment of premenstrual syndrome, Kessler added, wrote Bloomberg News.

The information comes in advance of the FDA’s public hearings on Yasmin, which are scheduled for December 8 in Maryland. The hearing will consider the drug’s safety and the controversial progestin, drospirenone and is being headed jointly by the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

In the U.S., over 10,400 individual lawsuits have been filed over Yasmin and Yaz. The lawsuits allege that Bayer did not appropriately warn patients and doctors about increased health risks associated with the drugs, versus safer oral contraceptives.

The majority of those lawsuits have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently waiting to be heard before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.

Bloomberg News pointed out that court papers indicate that women suing Bayer over its Yasmin birth control line allege that Bayer and its units went to extraordinary lengths to advertise the drugs for unapproved, off-label uses. In 2008, the FDA cited Bayer for Yaz TV ads that minimized the drug’s serious risks, mandating it spend millions on a corrective advertising campaign.

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