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Shezad Malik MD JD
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Yaz, Yasmin & Ocella: Benefits Over Touted?

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According to company e-mails, Bayer AG, Germany’s largest drugmaker, may have tried to market the Yasmin family of birth- control pills for unapproved uses and misled women about the health risks of the drugs.

Bayer unit officials discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of premenstrual syndrome, according to Bloomberg news. The FDA approved Yaz only for the most severe form of Pre Menstrual Syndrome (PMS), known as Premenstrual Dysphoric Disorder (PMDD).

Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives. The FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. Bayer’s contraceptives, which contain the hormone drospirenone, have been the focus of regulators who question their safety.

In October, the FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. According to the FDA report, the FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills. The FDA has scheduled its December 8 hearing on drospirenone- containing contraceptives, because of “the conflicting nature of the findings from six published studies evaluating this risk."

Injured women suing Bayer allege that internal company files show Berlex and Schering officials withheld some information from patients, doctors and the FDA about the drug’s risk for blood-clots. The plaintiffs also allege that company officials wrongfully claimed Yasmin and Yaz to be just as safe as rival birth-control pills.

In January, Bayer is scheduled to face the first mini trials, known as bellwether trials, of lawsuits in which Yaz and Yasmin are alleged to have caused blood clots, which can lead to pulmonary embolism, deep vein thrombosis, heart attacks and strokes. The trials are to take place in Illinois and Pennsylvania.

The FDA said Bayer made misleading claims about Yaz in television advertising, the drugmaker was forced to spend $20 million on correcting the ads. U.S. regulators said in 2008 that Bayer touted the pill’s effectiveness and downplayed “serious risks associated” with it in two 60-second television ads.

Bayer agreed to run new ads stating Yaz hadn’t been approved as a treatment for all forms of PMS or acne as part of a settlement of a claims brought by 27 U.S. state attorneys general.

Bayer bought Schering, then a rival German drugmaker, and its New Jersey-based Berlex unit for $21.8 billion to acquire the Yasmin line of contraceptives.

About 10,400 suits have been filed over injuries allegedly caused by the contraceptives, according to Bayer officials in an October filing with the U.S. Securities and Exchange Commission.

The federal cases are consolidated for pretrial purposes In Re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court for the Southern District of Illinois (East St. Louis).