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Yaz Lawsuits Increase after FDA enforces new label

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The number of lawsuits leveled against the PMDD medication company Yaz has risen significantly after the Federal Drug Administration ordered the company to place a stronger warning label on their product in April of 2012.

The stronger warning label states that ““some epidemiological studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products…whereas other epidemiological studies found no additional risk.”

A December 2011 FDA study found that women who take the birth control pills, which contain the active ingredient drospirenone , are at an increased risk of developing blood clots compared with women who take a contraceptive without drospirenone.

Despite the study, an FDA panel voted 15 to 11 to keep the controversial contraceptives on the shelves, deciding that the benefits of Yaz and drugs like it outweigh the risks. However, the panel did vote in a near unanimous decision to add stronger warning labels that specifically address the risk of blood clot.

Yaz has also been accused of dishonestly representing their product in television advertisements which has prompted the FDA to conduct a ‘corrective advertising’ study. The study will help to “answer questions about their recall and understanding of the benefit and risk information, their perceptions of the benefits and risks of the drug, and their intent to ask a doctor about the medication,”

In 2008 Bayer, which operates Yaz, was reprimanded by the FDA for minimizing the serious risks associated with the drug as well as broadening the drug’s indication to include PMS. The TV ads for the product were deemed to be in violation with federal statutes and regulation.

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