FDA Panel Vote on Beyaz Is Telling

Washington, DCIn the world of marketing, it's all about the spin and the added benefit. And in marketing Beyaz birth control, manufacturer Bayer plays up the inclusion of folate. The B vitamin is associated with good health, and the images of vibrant young women on the Beyaz site landing page suggest an active lifestyle. But what of Beyaz side effects?

To Bayer's credit, safety information concerning the drospirenone-based contraceptive is obvious and in plain view on the landing page, together with a link to a page that summarizes the outcome of the December 8 FDA (US Food and Drug Administration) expert panel vote pertaining to the safety and efficacy of Beyaz, which is a cousin of Yaz and Yasmin.

To that end, it appears that Bayer is being up-front with stated safety concerns regarding Beyaz birth control—specifically Beyaz blood clots—even in the face of its own position that Beyaz carries no greater risk of blood clots than any other birth control pills currently on the market.

Others, however, disagree with Bayer on this one—including women who have launched a Beyaz lawsuit.

A day after the FDA panel voted in favor of keeping Beyaz on the market but agreeing on the need to beef up warning labels, the Washington Post (12/09/11) tempered the expert panel's decision that the benefits of Beyaz continued to outweigh the risks with a summary of studies that, indeed, suggested a greater risk for blood clots in women using the latest-generation contraceptive containing drospirenone.

The FDA's own analysis, following a study of more than 800,000 women in the US, revealed that drospirenone-based pills—Beyaz drospirenone among them—carry a 74 percent higher risk for blood clots when compared with women who use no contraceptives whatsoever.

Bayer claims its own studies show no increased risk of blood clots amongst its products.

Meanwhile, the National Women's Health Network (NWHN) takes exception to the FDA expert panel's recommendation to allow Beyaz and other contraceptives containing the synthetic hormone drospirenone to continue on the market, albeit with beefed-up warnings. "These advisers told the FDA that preventing pregnancy is worth an increased risk of blood clots," said Cynthia A. Pearson of the NWHN. "We believe that women have a good range of safer contraceptive choices that don't put them at increased risk of life-threatening complications."

In the past, Bayer has been taken to task for playing up the unique benefits associated with their basket of new-age contraceptives, such as clearer skin, reduced bloating and now the benefit of a daily dose of a B vitamin (folate), while playing down the risks, including the side effects of Beyaz.

If the Beyaz website is any indication, Bayer is no longer hiding the stated risks behind a veil of secrecy. If Bayer's constituents are, indeed, represented by the images portrayed on the Beyaz website landing page, Beyaz buyers are young, hip and Internet savvy. They know where to find information, and they might as well find their information at the source.

Still, sales of drospirenone-based contraceptives have waned in light of the recent safety concerns, and doctors remain divided. So too, it seems, are the two FDA panels that convened December 8 to vet the drospirenone issue. While the combined panels voted to leave the products on the market with beefed-up warnings, the vote count is nonetheless telling. A commanding vote of 21-5 requiring stronger warnings was tempered with a closer vote of 15-11 that the benefits outweighed the risks.

That's two votes shy of a deadlock. Had two panel members voting YES voted NO instead, the result would have been a 13-13 tie. As it happened, nearly as many experts assembled felt that the risks outweighed the benefits, instead of the other way around.

Thus the debate over the side effects of Beyaz continues.