Product News and Recalls

Bayer seeks approval of contraceptive skin patch

According to a Reuters story, German drug manufacturer Bayer is seeking European approval of a contraceptive skin patch.

The story notes that Bayer’s main oral contraceptive brand, Yasmin, has generated controversy over health risks. The company has so far agreed to pay a combined $400 million to settle almost one third of about 6,000 legal claims in the U.S. that Yasmin caused blood clots. And thousands more legal claims are pending.

While all birth control pills can increase the risk of blood clots, a number of studies indicate that pills with the compound drospirenone can increase that risk up to three times compared to other oral contraceptives on the market.

Pills with drospirenone include Yaz, Beyaz and Ocella.

Bayer hopes the hormonal contraceptive patch, to be produced for Bayer by Swiss company Acino, will broaden its birth-control business and challenge Johnson & Johnson’s Evra patch.

Reuters says Bayer is one of the biggest players in an $8 billion global market for hormonal birth-control pills, competing with J&J, Teva’s Barr Pharmaceuticals and Ireland-based Warner Chilcott.

A spokeswoman for Bayer said the company is also in talks with the Food and Drug Administration over a possible filing in the U.S.

An advisory committee for the FDA recently recommended continued monitoring of Beyaz after a review that made note of 467 adverse events connected to the drug between Sept. 24, 2010, and May 1, 2012 — including 130 ranked as “serious” and five deaths.

Last year, an FDA panel voted narrowly to keep the birth control pills containing drospirenone on the market. Afterward, an investigation revealed that four of the panel members had financial or professional ties to the pills’ manufacturer. The FDA said past ties to the industry don’t meet the legal definition of conflicts, despite the fact that another panel member was denied a vote because he had previously expressed concerns about the contraceptives at issue.

Patients should consult their doctors before making any changes in their medication. A consultation with a Beyaz lawyer is also important if there are significant injuries while on Beyaz or similar birth control pills.

See the story here:

http://www.reuters.com/article/2012/09/20/us-bayer-contraceptive-patch-idUSBRE88J0SB20120920