The U.S. Food and Drug Administration has warned Pfizer in a letter that its ads for arthritis drugs Celebrex and Bextra are misleading.
The FDA said in a letter dated Jan. 10 and released on Wednesday that Pfizer (PFE) failed to disclose information on risks in different advertising campaigns and made “unsubstantiated effectiveness claims” in its ads. The letter alleged Pfizer violated provisions of the U.S. Food, Drug and Cosmetic Act.
Joan Hankin, an FDA consumer promotion analyst, sent a letter to Robert B. Clark, Pfizer’s vice president of regulatory affairs. In it, she said the agency focused in on five promotional pieces, including two television ads and print ad for Celebrex, as well as a Bextra direct mail brochure.
“These five promotional pieces variously: omit material facts, including the indication and risk information; fail to make adequate provision for the dissemination of the FDA-approved product labeling; and make misleading safety, unsubstantiated superiority, and unsubstantiated effectiveness claims,” the letter states.
The company’s blockbuster drug Celebrex has come under greater scrutiny recently for its possible link to an increased risk of heart problems when used long-term. Bextra also was cited last fall by FDA whistleblower David Graham as possibly raising the risk of cardiac problems.
Pfizer recently volunteered study results that showed Celebrex could cause heart troubles after prolonged use. For that reason, it appears Pfizer will face no penalty, however. Hankin said that Pfizer’s voluntary action prompted her to refrain from issuing a warning letter to the company.
“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,” Hankin wrote.
The FDA frequently warns drug companies about product ads that tend to emphasize a drug’s benefits, while downplaying or obscuring its health risks with the use of distracting audio or slick graphics.
Pfizer’s Celebrex TV ad features a woman finger-picking a guitar who says that by using the drug, she now can “play the long version” of a song.
The ad violates FDA rules because it makes a claim about Celebrex but does not follow up with potential side effects and risks of using the drug. If Pfizer were making what is known as a “reminder” ad or simply getting the name out to the public it wouldn’t have to state side effect.
Hankin found that Pfizer doesn’t state the approved treatment for the drug, which is relief of osteoarthritis.
Hankin also took issue with Pfizer’s failure to state Celebrex side effects for a TV ad that discusses arthritis tips. The ad states that the tips are “brought to you by Celebrex,” thus indicating it’s an arthritis treatment.
In a Celebrex print ad, Hankin says the company makes “unsubstantiated superiority claims” over ibuprofen or naproxen for arthritis treatment over an extended period.
“We are not aware of substantial evidence or substantial clinical experience to support these claims,” Hankin wrote.
A brochure for Bextra was cited for making claims that it protects the stomach more than other arthritis treatments. But the company provides Bextra warnings that say the drug can cause serious gastro-intestinal side effects, including bleeding in the stomach and intestines.
Finally, a TV infomercial for both Celebrex and Bextra overstates the proven effectiveness of each drug, Hankin said.