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FDA Blasts Ads For Celebrex, Bextra

January 13, 2004
Federal health officials are accusing Pfizer of violating federal law by making "misleading and unsubstantiated claims" about its prescription pain relievers Celebrex and Bextra, and said the company should stop all advertising for the products indefinitely. The company had temporarily suspended advertising in December.

Celebrex • Celebrex May Disrupt Heart Rhythm • Celebrex Gets Black Box Label • FDA Blasts Ads For Celebrex, Bextra • Can Pfizer Prevent Celebrex Ban? • Pfizer Finds Health Risk With Celebrex • Study Finds Celebrex Safer Than Vioxx • Celebrex Implicated in 14 Canadian Deaths --- Other NSAIDs • Merck Withdraws Vioxx • Pfizer Warns of Bextra Risks • Aleve Ingredient Seen as Health Risk •: Dangers of Cox-2 Drugs • Life Without Vioxx

In a letter to the drug company, the Food and Drug Administration accused Pfizer of not telling consumers about possible risks for taking the drugs.

"The seriousness of the violations concerning your promotion of Celebrex...would generally have warranted a Warning Letter; however, in light of your recent agreement to a voluntary suspension on all consumer promotion for Celebrex, we do not feel that is appropriate at this time," the fax said. "You should be aware, however, of the serious nature of the violations described above and act to avoid disseminating similarly misleading promotion for your products in the future."

Pfizer suspended its advertising last month after a study found that high doses of Celebrex led to higher rates of heart attacks.

Celebrex and Bextra are both COX-2 inhibitors, similar to Merck Pharmaceutical's Vioxx, which was voluntarily withdrawn from the market in September after research indicated it might increase the risk of heart attacks and strokes. When government scientists suspended clinical trials using Celebrex because of concerns about its health effects, company officials mounted a vigorous defense of the drug.

In its letter to Pfizer, the FDA outlined its objections to the company's advertising campaign, taking aim at messages delivered through TV infomercials, direct mail and print advertising. It said the claims made in the advertisements appeared to be a serious breach of U.S. law.

In a stern warning to Pfizer, the FDA said it is considering a warning label for Celebrex, and might even ban it from the marketplace. Pfizer's CEO told reporters last month that the company does not plan to withdraw Celebrex and, though suspending advertising to consumers, would continue to market it to doctors.

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