NEW YORK, Feb. 22, 2012 — A watchdog group wants the U.S. Food and Drug Administration to reopen its debate about Yaz blood clot risks and the coagulum dangers of similar birth-control pills, including Yasmin.
Many believe an extended discussion about these drospirenone-based contraceptives would be in the best interests of the millions of American women who rely on this drug for pregnancy prevention.
Interest in such a dialogue is particularly keen just now among individuals, organizations and policymakers alarmed about the right of women to access contraceptives.
One such group calling for more debate is the Project on Government Oversight (POGO). The organization is asking the FDA vote anew on whether the Yaz blood clot risk outweighs its benefits. An FDA advisory panel in December voted by a slim margin of just four votes out of 26 total cast to recommend the agency keep Yaz and its imitators on the market, despite the concerns over blood clots. POGO identified four voters on that advisory panel who had financial relationships or business connections with the makers of the birth-control pills at issue.
Critics of that vote – who include Yaz injury lawyers – assert that the FDA needs to ensure a fair and honest debate about the Yaz blood clot risk by removing from the discussion those participants who have conflicts-of-interest.
The risks cited by medical studies and by the FDA with regard to drospirenone-based birth-control pills include venous thromboembolism and, in at least 100 cases, death.
Press contact: Rich Smith, Weitz & Luxenberg, (212) 558-5885, Email
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