Swiss officials are jumping into the debate over the safety of Bayer's (BAYRY) contraceptives, investigating a possible link between the deal of a woman from a blood clot 10 months after she was prescribed the low-dose pill Yaz. Both Swissmedic and an investigative judge are probing the death.
The case comes at a time when Yaz and its sister drug Yasmin are under scrutiny in plaintiff's lawsuits, post-marketing safety studies sponsored by Bayer, studies by independent researchers, and a safety review by the FDA. And it follows FDA action against Bayer's advertising of Yaz, which the agency called misleading. The ads not only promoted Yaz for off-label uses, but minimized serious risks and overstated its efficacy, the FDA said.
Yaz is the top-selling birth control pill in the U.S., the New York Times reports, and together with Yasmin accounted for $1.8 billion in sales last year. So the safety questions have the potential to damage one of Bayer's leading franchises.
But there's far from universal agreement that the contraceptives are any more dangerous than other oral contraceptives. A large Bayer-financed study found that the drugs carried no increased cardiovascular risks compared with older birth-control pills. Two studies just published last month, however, found that newer contraceptives such as Yaz were linked with a higher risk of blood clots. Bayer is conducting another safety study now, while the FDA is reviewing the safety of oral contraceptives, including Yaz and Yasmin.
- get the release from Swissmedic (German)
- read the Bloomberg story
- see the article from Reuters
- check out the NYT analysis