The FDA Debates Pulling Yaz from the Market
This holiday season might not be Bayer’s happiest, depending on the result of the FDA’s meeting on December 8 regarding Yaz, Yasmin and comparable birth control pills. The FDA is currently reviewing evidence to determine if Bayer’s birth control pill Yaz will be allowed to remain on the market. Attendees of the meeting will discuss the benefits and risks, specifically risks related to blood clots, of Yaz.
In a safety announcement released September 26, 2011, the FDA disclosed its concern over the potentially increased risks of blood clots associated with dropspirenone-containing pills, including Yaz, Yasmin and Ocella. The FDA has reviewed several studies, including one FDA-funded study that indicated a 1.5-fold increase in the risk for blood clots associated with Yaz and similar pills. Other studies have found even higher risks for blood clots. Bayer currently faces 9,300 lawsuits over claims that Yaz has caused blood-clot related strokes, heart attacks and fatalities, as well as gallbladder issues.
Yaz was introduced to the U.S. market in 2006, and it met with overwhelming success. Within two years, Yaz cornered 18 percent of the entire oral contraceptives market. Although the patent on Yaz has run out, allowing generic versions to enter the market, Yaz is still a very popular pill. If the FDA’s decision in December is to remove Yaz from the market, Bayer will no doubt take a major financial hit, and millions of American women will need to find a safer alternative for birth control.
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