Bayer’s birth-control pills under FDA scrutiny

Catherine Larkin
Bloomberg
June 1, 2011

Bayer AG’s birth-control pills will be reviewed by U.S. regulators after some studies suggested the products may cause more blood clots than competing medicines.

Two recent reports in the British Medical Journal found a two- to threefold greater risk of blood clots in women taking pills such as Bayer’s Yaz, contradicting some earlier data, the Food and Drug Administration said Tuesday in a statement.

European regulators said last week that they were revising the products’ prescribing information to include the new safety findings.

While all birth-control pills pose a risk of blood clots, the FDA review focuses on the hormone drospirenone, found in Bayer’s Yaz, Yasmin, Beyaz and Safyral. The agency expects to have results “later this summer” of an 800,000-person study it commissioned to examine the risks. In the meantime, regulators said doctors and patients should watch for symptoms of blood clots, including leg or chest pain.

“FDA will continue to communicate any new safety information to the public as it becomes available,” the agency said in its statement.

The Yaz family of products generated $1.47 billion in sales last year for Bayer, or 3.3 percent of the company’s revenue.