Product News and Recalls

Despite FTC decision, problems persist for Yaz maker

The Federal Trade Commission found no evidence that antitrust regulations were breached in a deal between German drugmaker Bayer AG and a division of Teva Pharmaceuticals to end patent litigation over Bayer’s Yasmin birth control pill.

Fox Business reports that the FTC had been investigating a deal made by Bayer and Barr Laboratories, which was purchased by Teva, in 2008. It was supposed to settle a three-year fight over whether Barr infringed on Bayer’s “Yasmin” patent to make its own generic contraceptives.

Under the supply and licensing agreement, Barr paid Bayer a fixed percentage of its revenues for the contraceptive.

The article notes that Yasmin, Bayer’s main contraceptive brand, has been a subject of controversy over health risks.

Although all birth control pills can increase the risk of blood clots, a number of studies indicate that pills containing the synthetic hormone drospirenone can increase that risk up to three times compared to other contraceptive on the market. Pills with drospirenone include Yasmin, Yaz, Beyaz and Ocella.

The story says Bayer recently agreed to pay a combined $400 million to settle almost one third of about 6,000 legal claims in the United States that Yasmin caused blood clots.

Also this year, the U.S. Food and Drug Administration added information to the labels on Bayer’s contraceptives with drospirenone, stating that they may raise the risk of blood clots.

According to Fox Business, the FTC has battled – and even pushed for legislation to ban — what it calls “pay for delay” settlements for years, with mixed success. In pay for delay deals, brand-name drug companies typically sue generic firms for infringement and then settle, with the generic firm agreeing to delay entry into the market.

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: