Product News and Recalls

Should Beyaz/Yaz be recalled?

Following close on the heels of the December 8, 2011 U.S. Food and Drug Administration advisory panel vote on Yaz/Yasmin/Beyaz, the FDA is planning a new panel to examine the question of whether all-metal hip implants, plagued by a high failure rate and other health concerns, should remain on the market.

The FDA panel on birth control has already voted that Beyaz, Yaz, and other contraceptives containing the compound drospirenone should remain on the market. But in the opinion of many public safety advocates, the question is far from settled.

A number of studies have demonstrated that birth control pills with drospirenone are up to twice as likely to cause potentially fatal blood clots as other types of oral contraceptives.

On Dec. 8, a joint meeting of the FDA’s Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee voted 15 to 11 that the benefits of pills containing drospirenone outweigh the risks.

But that vote has drawn a good deal of criticism because of the nature of the panel.

A subsequent investigation revealed that four members of the panel had financial or professional ties to Bayer, the manufacturer of the pills being evaluated. Despite that, another panel member was denied a vote over an alleged “intellectual conflict of interest,” simply because he had previously expressed concerns about the contraceptives at issue.

Executive directors of the Jacobs Institute of Women’s Health, the National Research Center for Women & Families, the National Women’s Health Network, and Our Bodies Ourselves recently addressed a letter to FDA Commissioner Margaret Hamburg, M.D., voicing some of their concerns.

Another problem with the panel, they wrote in the letter, was apparent in written explanations that members provided for their votes. Members who voted to keep the pills on the market were apparently under the impression that they were supposed to be deciding whether contraceptives were more dangerous than pregnancy, as opposed to other types of contraception.

They concluded by asking the FDA to reevaluate the policy.

Meanwhile, thousands of lawsuit plaintiffs allege that they’ve suffered from blood clots, pulmonary embolism, and stroke brought on by Yaz, Beyaz, Yasmin, Ocella, and other birth control pills with drospirenone.

If you or a loved one has suffered injury as a result of taking any of these pills, contact Lopez McHugh for a free case evaluation.