FDA finds Celebrex ads misleading
Pfizer spent more than $70 million to promote the arthritis drug last year.
WASHINGTON (AP) -- Advertisements for the arthritis drug Celebrex were misleading and unsubstantiated, overstating the pain reliever's benefits and understating the risks, the government said Wednesday.
The Food and Drug Administration asked for an immediate halt to all ads for Celebrex, which Pfizer Inc. did last month in advance of the agency's letter. A study in December found high doses of Celebrex were associated with an increased risk of heart attack.
The letter, sent Monday and released Wednesday, details the misleading and unsubstantiated claims in ads for Celebrex and a related drug, Bextra, that appeared on television, in print, on TV infomercials and in direct-mail brochures. The government said the claims represent serious violations of federal law.
New York-based Pfizer spent more than $70 million advertising best-selling Celebrex to U.S. consumers in the first nine months of last year. It has run minimal consumer ads promoting Bextra.
When Pfizer voluntarily pulled its ads in December, the company said it planned to keep Celebrex on the market and would continue marketing the drug to doctors.
Vioxx, a drug in the same class as Celebrex, has been found to be associated with higher rates of heart problems and stroke. Its manufacturer, Merck & amp; Co., pulled the pain killer off the market last fall.
The FDA has said it is considering warning labels for Celebrex or ordering its withdrawal from the U.S. market altogether.
Before the recent studies detailing their side effects, anti-inflammatory drugs such as Celebrex and Vioxx were heavily promoted by the pharmaceutical industry as being more effective and less irritating to the stomach than some other pain relievers. But five ads for Celebrex and/or Bextra reviewed by the FDA were found to be misleading and in violation of federal law, the agency said. They omitted facts, including information about risks, wrongly claimed superiority and made unsubstantiated claims about the drugs' effectiveness, the FDA said.
The FDA asked the company to detail any ads that make similar misleading claims and keep them off the air as well.
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