Yaz, Yasmin, and Ocella on FDA Radar for Downplaying Risks and Overstating Effectiveness

In the recent Spring publication of The American Trial Lawyer, the birth control pills, Yaz, Yasmin, and Ocella are chronicled from their market inception to their manufacturers’ legal battles over failure to adequately warn consumers about their drugs’ risks. Yaz and Yasmin, both manufactured by Bayer, have been linked to heart attacks, strokes, blood clots, and kidney and bladder damage. Ocella, the generic version manufactured by Teva Pharmaceutical Industries, Inc., has also been linked to the same risks. Bayer purchased Berlex Laboratories, the maker of Yaz and Yasmin, in 2006, and immediately began a strong marketing campaign once they acquired the first birth control pills containing drosperinone, a unique progestin. Ocella also contains drosperinone.

It is drosperinone that the FDA is concerned about. Two studies in the British Medical Journal in August 2009 found that birth control pills containing drosperinone increased the risk of having blood clots. Bayer, however, preformed their own study and found that their was no greater risk associated with their pills containing drosperinone than birth control pills not containing the unique progestin.

In addition to the FDA’s concern about drosperinone, they sent three warning letters to the manufacturers in the past six years regarding their advertisements that overstate the effectiveness of the pills and downplay the risks. The FDA took special concern when the manufacturers advertised that the pills could treat PMS, when in fact they treat premenstrual dysphoric disorder (PMDD), a more severe form of PMS. Furthermore, the manufacturers overstated the acne fighting ability of Yaz and Yasmin. Yaz and Yasmin are effective at treating moderate acne; the pills cannot result in acne-free skin.

In February 2009, the FDA and the attorneys general of 27 states required Bayer to spend more than $20 million correcting the misleading information in their advertisements. In addition, Bayer is required to submit all advertising for its birth control pills to the FDA for pre-approval for the next six years.

Sheller, P.C. is currently handling Yaz, Yasmin, and Ocella claims. If you, your daughter, or someone you love has been injured as a result of these contraceptive drugs, please contact Sheller, P.C.