Yasmin under investigation by FDA
FDA investigates birth control drugs that were heavily promoted as having fewer side effects and the ability to clear up acne and other hormonal bothers. Research suggesting that newer birth control formulations are more likely to cause blood clots than older drugs has prompted the Food and Drug Administration to consider new safety measures in meetings later this week. The increased risk is slight but significant because blood clots can cause heart attacks, strokes and blockages in lungs or blood vessels, which can be fatal.
Regulators could order new warning labels on several contraceptives that gained popularity in the last decade, including Bayer’s pill Yaz, which was the best-selling birth control drugs pill in the U.S. for 2008 and 2009. Yaz, its Bayer precursor Yasmin, and similar drugs use a version of a female hormone that appears to reduce side effects found in older drugs, including bloating and mood swings. On Tuesday, a judge unsealed several court documents suggesting Bayer may have withheld data from FDA about the blood clots risks of its drugs. The documents stem from expert opinion gathered by personal injury lawyers suing Bayer on behalf of patients.
According to one document, Bayer drafted a white paper in 2004 to address “FDA concerns,” about clots with birth control drugs Yasmin. An early draft indicated that reports of blood clots with Yasmin were significantly higher than those for three other oral contraceptives. But that information was not included in the final paper submitted to the FDA, and instead the company said a more definitive study of blood clot risk would be forthcoming. That study did not show an increased risk. The FDA declined to accept the court documents for this week’s hearings, saying the deadline for submissions was last month, according to an emailed message from an agency officer. A Bayer spokeswoman said the company had no comment on the material in the documents, noting the issues would be addressed at trial. Bayer AG spent more than $270 million on TV and magazine advertisements for Yaz between 2007 and 2010, according TNS Media Intelligence.
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