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Controversy Surrounds the FDA’s Decision to Keep Yaz On the Market

Published June 20, 2012 on

The FDA recently mandated that Bayer Pharmaceuticals change the warning labels on two of its most popular birth control pills to reflect recent research relating to blood clots as a result of Yasmin or Yaz. The decision comes in the midst of many ongoing lawsuits against Bayer and generic Yasmin or Yaz manufacturers relating to side effects resulting from Yaz, and has been met with criticism from watchdog groups and other advocacy groups accusing the FDA of not doing enough.

FDA addresses concerns about blood clots as a result of Yaz

In December of last year, an FDA panel of 26 advisors elected to institute the new warnings rather than remove the pills from the consumer market. The vote tallied 15 to 11 in favor of keeping the hormonal birth control pills on the market, but 21 to 5 in favor of instituting stronger warnings about blood clots. Panel members reasoned that the drugs should be kept on the market because the benefits they offer outweigh the possible risks.

In crafting the language of the new warning labels, the FDA has required that they “report that some epidemiologic studies reported as high as three-fold increase in the risk of blood clots for drospirenone-containing products [(the active ingredient in Yasmin and Yaz)] whereas other epidemiological studies found no additional risk.” However, this decision remains controversial as several women’s advocacy groups have pointed out that some of the studies falling in the latter category received funding from Bayer or other contraceptive industry players, and thus may not have been objective, and the results therefore unreliable.

Further adding to the controversy, it has since been discovered that four of the twenty-six FDA panel members had previous affiliations with manufacturers of contraceptives containing drospirenone. The compromising nature of this potential conflict of interests compelled the watchdog group Project on Government Oversight to advocate for a new review and vote on the continued sale of contraceptives like Yasmin and Yaz. Further, on March 9, 2012 a group of four women’s advocacy organizations sent a letter to FDA Commissioner Margaret Hamburg voicing concern about the administration’s decision to keep the drugs on the market.

Many women have been filing a Yasmin lawsuit

As the federal regulatory controversy over Yasmin and Yaz unfolds, plaintiff after plaintiff continues to file a Yaz lawsuit against Bayer and generic Yaz manufacturers alleging health complications like blood clots. Almost 7,000 of these lawsuits have been consolidated into an Illinois multi-district litigation under presiding Judge David R. Herndon. Judge Herndon has actively encouraged parties to seek resolution outside of court by pushing back the initial trials several times.