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Bayer cleans up Yaz ads at FDA's behest
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Added by
madameape on 11 Feb 2009
From: www.iht.com
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| Image courtesy nateOne via Flickr |
In an unusual move, the FDA has ordered Bayer to stop advertising its leading birth-control pill, Yaz, as a drug for mood swings and acne, and to clearly state its potential harmful side effects in future commercials.
From the IHT: "The FDA first moved against the Yaz campaign last October, with a warning letter to Bayer saying that two television ads overstated the drug's benefits while understating its risks. By giving consumers the impression that Yaz was generally a drug for acne and general mood problems, the company's ads ran afoul of U.S. government laws against promoting the unapproved uses of a drug, the FDA said. The agency approved Yaz in 2006 as a birth control pill that has a side benefit in treating mood-related psychological problems called premenstrual dysphoric disorder.
In 2007, the agency approved another side benefit of Yaz, that of improving moderate acne. But Yaz contains drospirenone, a progestin that can cause excess potassium production in some patients, its side effects include an increased risk of serious heart and other health problems.
After the FDA complained, Bayer halted the Yaz ads. The agency told Bayer to submit a media plan for a corrective message that would reach the same size and kind of television audiences as the misleading ads did."
From the IHT: "The FDA first moved against the Yaz campaign last October, with a warning letter to Bayer saying that two television ads overstated the drug's benefits while understating its risks. By giving consumers the impression that Yaz was generally a drug for acne and general mood problems, the company's ads ran afoul of U.S. government laws against promoting the unapproved uses of a drug, the FDA said. The agency approved Yaz in 2006 as a birth control pill that has a side benefit in treating mood-related psychological problems called premenstrual dysphoric disorder.
In 2007, the agency approved another side benefit of Yaz, that of improving moderate acne. But Yaz contains drospirenone, a progestin that can cause excess potassium production in some patients, its side effects include an increased risk of serious heart and other health problems.
After the FDA complained, Bayer halted the Yaz ads. The agency told Bayer to submit a media plan for a corrective message that would reach the same size and kind of television audiences as the misleading ads did."
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