FDA issues warning over Celebrex, Bextra ads
The FDA has issued a warning letter to Pfizer stating that television and print ads for its painkillers Celebrex and Bextra are misleading to consumers.
A total of five advertisements failed to disclose side effects and other risk information and made "unsubstantiated effectiveness claims," the letter posted on the FDA's Web site Wednesday said.
A company spokeswoman told Reuters the Celebrex ads cited in the letter were no longer running. The spokeswoman had no comment on the other materials including a Bextra patient brochure and a television infomercial.
Pfizer said in a Reuters report it would discuss its next steps with the FDA. The letter gives Pfizer until Jan. 26 to respond.
On Dec. 17, the National Institutes of Health halted a cancer trial using Celebrex after researchers discovered an increased risk of heart attack.