FDA Says Bayer Downplaying Yaz & Yasmin Risks As More Women Report Serious Injuries

The U.S. Food & Drug Administration (FDA) has sent Bayer Pharmaceuticals at least three warning letters that the pharmaceutical giant must stop its misleading marketing and advertising campaigns over its oral contraception drugs Yaz and Yasmin. Although the drug manufacturer has agreed to spend $20 million to change its ads, more and more women are reporting serious injuries in conjunction with what Bayer touted as the latest and greatest birth control medications – and Yaz/Yasmin lawyers say that thousands of lawsuits are likely to be filed within the next year.

FDA warnings

The FDA has sent Bayer at least three warnings about its marketing practices and another on its manufacturing processes in one of its German plants. Here are the details:

• Marketing practices. The FDA warned Bayer on at least three different occasions about its marketing and advertising practices surrounding Yaz and Yazmin birth control products. In particular, the FDA accuses Bayer of providing false and misleading statements about the risks and benefits of each and downplaying the serious side effects that are being reported. Bayer has agreed to spend $20 million to correct its advertising campaign.
• Manufacturing processes. The FDA has also warned Bayer about substantial problems and its failure to conform to good manufacturing processes in one of its German plants which makes the key ingredients for both Yaz and Yasmin. In particular, the FDA accuses Bayer of hiding data which should have kept several batches of the drugs from being shipped to the United States.

What Yaz & Yasmin users are reporting

Both Yaz and Yasmin, which contain drospirenone & ethinyl estradiol (estrogen), are thought to dangerously increase potassium levels. While this can result in the formulation of blood clots and lead to strokes and pulmonary embolisms, other side effects have been reported such as depression, heart attacks, kidney damage, liver damage and a host of others. Here's what a two women have reported on Internet blogs:

• Yaz user: I am a national champion marathon canoeist and a very avid runner. I recently suffered a pulmonary embolism while taking YAZ. I don’t smoke and I am [only 22 years old]. I really hope every young woman is aware of the horrible and potential risks for ALL women (not just smokers and those over 35) taking this form of oral contraception.
• Yasmin user: I’ve been taking Yasmin since July of 2007 [and have] been dealing with heart problems ever since. ...I’m only 25 years old and [have] a 2 year old girl. I was not ready to deal with hypertension for the rest of my life. [It wasn't until recently that I found out that] this pill that was causing all these problems along with some liver problems. My heart goes out to those families that lost some one for this. Effective today, I discontinued [using the] pill.

Women are also beginning to file lawsuits against Bayer alleging that it knew about the risks of Yaz and Yazmin, but failed to warn users about those risks. While 50 Yaz and Yasmin product liability lawsuits have already been filed, Yaz/Yasmin attorneys alike say that they expect over 1,000 such suits to be filed against the company within the next year.