Bayer accused of promoting Yaz birth control for unapproved uses

Company faces off-label marketing allegations in lawsuits

For years, Bayer AG has faced lawsuits concerning the safety of its Yaz birth control medication. Now, the German drug company is accused of marketing its oral contraceptives for unapproved uses as well as keeping women in the dark about the drug’s health risks.

According to company emails that were disclosed as part of litigation in which plaintiffs claim that Yaz caused serious health problems, Bayer officials discussed how to promote Yaz as a treatment for all types of premenstrual syndrome (PMS) even though U.S. regulators had only approved the drug to treat the most severe form of PMS. Bayer officials sent salespeople an email saying that they should cite a Woman’s Day magazine article when touting Yaz as a safe PMS treatment.

Regulators have questioned the safety of Bayer’s contraceptives, which contain drospirenone, a synthetic hormone that can alter the body’s normal balance of salt and water and lead to elevated potassium levels that can cause major health issues, such as blood clots, heart attacks and strokes. Lawyers representing the plaintiffs who are suing Bayer claim that the Food and Drug Administration (FDA) reported at least 50 deaths tied to the company’s birth control pills between 2004 and 2008. Bayer faces more than 10,000 lawsuits from plaintiffs who claim the birth control pill caused injuries.

The FDA recently conducted a study revealing that women who took drospirenone-containing pills, including Bayer’s Yaz, were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. The agency has scheduled a hearing for Dec. 8 to further discuss its findings.

Visit Bloomberg for more information about Bayer’s alleged off-label marketing.

Ashley Post

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