Product News and Recalls

Former FDA director: Bayer withheld info on Yaz

According to Bloomberg, a former director of the U.S. Food and Drug Administration reported that pharmaceutical maker Bayer withheld company research indicating that its Yasmin line of birth control pills caused increased blood clots.

David Kessler, the former FDA commissioner, made those allegations in a report unsealed as part of the ongoing litigation on behalf of patients claiming to be injured by the contraceptives, Bloomberg reports.

It quotes Kessler as saying: “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”

The Yasmin line of pills – which includes Yaz, Beyaz and Ocella – contains the synthetic hormone drospirenone.

The U.S. Food and Drug Administration recently changed the labels of the Yasmin line to add information warning users that numerous studies found as high as a three-fold increase in the risk of blood clots from those pills compared to other contraceptives on the market.

Bayer faces more than 11,000 lawsuits over allegations that the company didn’t sufficiently warn patients of those health risks. Lawyers for the plaintiffs cite FDA reports of at least 50 deaths tied to the pills from 2004 to 2008.

According to Kessler, Bayer withheld an internal study about Yasmin’s risks of clots before the drug was approved by the FDA in 2001.

See the report here: http://www.bloomberg.com/news/2011-12-05/bayer-withheld-yasmin-clot-risk-data-from-u-s-ex-agency-head-tells-court.html