Product News and Recalls

New Beyaz warnings may not be strong-enough

A women’s health advocate said she’s afraid the U.S. Food and Drug Administration’s decision to change the warning label on certain types of birth control pills won’t be enough to protect users from the increased risk of blood clots.

On April 10, the FDA announced the label change for birth control pills containing the synthetic hormone drospirenone, including Yaz, Yasmin, Ocella and Beyaz.

The new labels reflect the findings of multiple studies, which revealed that the contraceptives with drospirenone carry up to three times the risk of potentially fatal blood clots compared to other pills on the market without the compound.

But Cynthia Pearson, executive director of the National Women’s Health Network, told Fox News that might not be sufficient.

Pearson testified at a December hearing that the FDA held about the risks of birth control pills with drospirenone, which included tearful testimony shared by families about sudden deaths or life-changing disabilities brought on by blood clots while using Yaz or Yasmin.

The 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.

“I fear that if the FDA holds another public hearing three years from now, there will be a new group of women telling sad stories about the harm done to their health by clots,” Pearson said.

See the report here: http://www.foxnews.com/health/2012/04/11/us-adds-more-on-clot-risk-to-some-birth-control-pills/