Product News and Recalls

Activist questioned corporate-funded Yaz studies

A former board member of Our Bodies, Ourselves, a nonprofit women’s advocacy group, publicly questioned why industry-funded studies were the only ones that appeared to show no higher risk of blood clots from the Yasmin line of contraceptives, compared to other types of birth control pills on the market.

An entry in the organization’s blog mentions testimony that Pamela Bridgewater presented at a U.S. Food and Drug Administration panel’s December meeting, at which panel members discussed the approval status of birth control pills containing the compound drospirenone, which include Yasmin, Yaz, Beyaz and Ocella.

Numerous studies, including one that the FDA itself conducted, indicate that the pills with drospirenone carry up to three times the risk of potentially fatal blood clots compared with other types of birth control pills on the market.

Two studies didn’t come to that conclusion, and both were funded by the pills’ manufacturer. Even those couldn’t rule out a correlation between drospirenone and blood clots beyond the margin of error.

According to the blog, Bridgewater asked the panel to consider why “the studies that had the closest ties to Bayer show no evidence of an increase in blood clots.”

Cindy Pearson of the National Women’s Health Network also testified before the panel, asking the FDA to “take these more dangerous and no-more-beneficial products off the market, and get back to the arc of history and progress that protects women while supporting their contraceptive choices.”

As the blog entry notes, the panel members eventually voted narrowly to keep the drospirenone pills on the market. But four members, enough to push the vote the other way, later turned out to have financial or professional ties to Bayer.

See the blog entry here:

http://www.ourbodiesourblog.org/blog/2012/03/concerns-about-the-fdas-review-of-the-safety-of-yasmin-and-similar-contraceptives