Watchdog group pushes FDA panel to revote on Yaz safety
January 26th, 2012 by Jennifer Walker-Journey
A consumer watchdog group is calling for a revote by a Food and Drug Administration (FDA) advisory panel, after discovering that some members of the panel had ties to drug companies that made the pills under review.
The FDA panel was charged with reviewing studies that showed a newer generation of birth control pills containing the hormone drospirenone put women at greater risk for life threatening blood clots than other oral contraceptives with other hormones. Drospirenone-containing pills include Yaz and Yasmin, made by Bayer. The drug company also sells versions of the pills containing folic acid under the brand names Beyaz and Safyral. Generic versions are also available.
While all birth control pills carry a risk for blood clots, new studies have shown drospirenone-containing pills to be more dangerous. Blood clots are a serious and potentially deadly medical condition. If the clots break free, they can travel to the heart and cause heart attack, travel to the brain and cause stroke, or travel to the lungs and cause pulmonary embolism.
The FDA ordered a review of the pills based on these new studies. The panel fell short of recommending banning the pills, opting instead to put stronger warnings on the drug’s safety label.
Following the vote, POGO (Project on Government Oversight) discovered that three of the panel’s advisers had research or financial ties to Bayer. A fourth adviser had a connection to Teva Pharmaceuticals, maker of generic versions of the pills. All four of those advisers voted to keep the drugs on the market, noting that the benefits of the pills outweighed the risks.
“The American public must be able to trust that the FDA and its advisory committees are making decisions based on science, not industry influence,” POGO Executive Director Danielle Brian told Huffington Post. The organization argues that a revote on the panel’s recommendation is in the best interest of the consumer.
Source: Huffington Post