New Article Suggests Bayer May Have Promoted Yaz/Yasmin for Unapproved Use

An article out today on Bloomberg.com states that units of Bayer AG, Germany's largest drug maker, may have promoted its birth control pills, Yasmin and Yaz, for unapproved uses. The article also indicates Bayer may have misled women about the health risks the drugs pose.

According to the article, certain documents, including company e-mails, show Bayer employees discussing promoting Yaz for PMS when the drug has not been approved for treatment of PMS, but rather the more serious form of the disorder called PMDD (premenstrual dysphoric disorder). Yasmin on the otherhand has not been approved for any uses other than as a contraceptive.

Bayer was previously ordered by the FDA to correct misleading claims about Yaz in its television ads in 2008. Now, the FDA has scheduled hearings on the risks that Yaz/Yasmin (drospirenone-containing birth control pills) pose to women, specifically the potential increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism). The full-day hearing with independent scientists is scheduled for December 8, 2011. Representatives from our offices plan to monitor the hearings and will provide updates shortly thereafter.