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Yasmin and Yaz Warnings

Although the Food and Drug Administration has yet to issue a Yasmin and Yaz recall, the agency and other groups have issued several warnings about health risks and other problems associated with the birth control pills.

The FDA’s Division of Drug Marketing, Advertising and Communication sent a warning letter to Bayer in October 2008 concerning the company’s “false and misleading” Yaz ad campaign. The letter stated that the company’s series of television ads for Yaz improperly promoted the birth control pills as a treatment for acne and PMS symptoms—two conditions which is was not approved to treat—while failing to fully disclose the side effects of Yaz. As a result of the FDA letter, Bayer was forced to air a $20 million ad campaign to correct the misleading claims of its original TV commercials.

The FDA sent a second warning letter to Bayer in September 2009 after an inspection of the company’s plant revealed manufacturing problem with several batches of drospirenone, the main ingredient in Yaz and Yasmin, that were later sold in the U.S. The FDA said that these “adulterated” batches should have never left the manufacturing plant because of questions about their quality.

The consumers group Public Citizen added Yasmin to its “Do Not Use!” list of drugs in April 2002 over concerns about the side effects of the birth control pill. The group said that consumers should other birth control pills instead of Yasmin and products containing drospirenone, which include Yaz and Ocella, due to an increased risk of blood clots and other heart problems. Public Citizen later sent a petition to the FDA calling on the agency to ban Yaz, arguing that the risk of side effects from the birth control pill outweighed its contraceptive benefit.

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