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Bayer Accused Of Marketing Birth Control For Unapproved Uses

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Claims are being made against Bayer, Germany’s largest drug maker, for marketing Yasmin® birth control pills for unapproved uses and misleading women about the health risks associated with it. Disclosed company emails appear to show that Bayer unit officials discussed promoting Yaz®, a contraceptive spinoff of Yasmin, to treat all types of premenstrual syndromes although the drug was approved by U.S. regulators to only treat the most severe forms of premenstrual syndrome (PMS). Bayer faces over 10,000 Yaz lawsuits brought by women who allege they were injured by Bayer’s birth control dugs.

According to a copy of an email sent by Matt Sample, a Berlex sales consultant, regarding an article published in Woman’s Day Magazine “This article is a nice way of using YAZ for PMS treatment instead of just focusing on the specific class of women battling premenstrual dysphoric disorder, the most severe form of PMS.”

This email message along with other internal company files was disclosed as part of the litigation. Claims are being brought against the company that the drug causes blood clots, heart attacks, and strokes.

In an interview with Bloomberg News, Rose Talarico, U.S. based spokeswoman for the company, stated that “Bayer’s oral contraceptives have been and continue to be extensively studied worldwide and are safe and effective when used as directed and according to product labeling.”

In 2010, Bayer’s birth control generated sales of $1.58 billion according to Bloomberg News. However, the main ingredient known as drospirenone is raising safety concerns for health regulators.

The Food and Drug Administration (FDA) warned that women taking birth control pills were 74% more likely to suffer blood clots than women on other low-estrogen contraceptives. Over 800,000 women, who took birth control pills containing drospirenone, including the line of Yasmin birth control pills, were examined. On December 8, 2011, the FDA is set to discuss their findings and could possibly announce new mandatory warnings for those birth control dugs.