FDA warns Pfizer on misleading Celebrex, Bextra ads

Since the recall of Vioxx on September 30, 2004 by Merck, Pfizer, the maker of other two Cox-2 drugs, Celebrex and Bextra, aggressively marketed the two drugs as alternatives to Vioxx. The big direct-to-consumer advertising campaign continued till several studies showed that both Celebrex and Bextra are not as safe as they have been made out to be. (Related article: Vioxx too was aggressively marketed to consumers by Merck)

FDA directed that the label for Bextra be changed to clearly show its adverse side effects. FDA and Pfizer also agreed that Pfizer will stop all direct-to-consumer advertising for Celebrex till its safety profile was better understood and the FDA could evaluate the safety of Cox-2 class and decide if a recall of Celebrex and/or Bextra was necessary. (Related article: Celebrex, like Vioxx, may be recalled)

Pfizer has maintained all along that Celebrex was still a safe drug and has conveyed this message in various statements, press releases, and television interviews. Most doctors, however, do not agree with Pfizer's assertions. The majority of physicians are suggesting that prescription of Cox-2 drugs like Celebrex and Bextra be limited to very special situations since none of these drugs are in any way better than over-the-counter painkillers and have serious adverse side effects. Vioxx is estimated to have killed/injured as many as 139,000 Americans and an unknown number outside the US.

The FDA has now sent a letter to Pfizer warning it about its misleading advertisements related to both Celebrex and Bextra. It is well known that Pfizer has received similar warnings for its other products for making claims that were either not true or were not substantiated by evidence. In a very strongly-worded letter, the FDA talks about five different ad pieces that it has found to be totally unacceptable. The FDA has directed that, "Pfizer immediately cease the dissemination of promotional materials for Celebrex and Bextra that contain claims and presentations the same as or similar to those described (in the letter)....The seriousness of the violations concerning your promotion of Celebrex described above 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. 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." (Related article: Celebrex lawsuits follow the Vioxx class action lawsuits)

For the benefit of our readers, below are portions of the letter from the FDA to Pfizer.

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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. They are, therefore, in violation of the Federal Food, Drug, and Cosmetic Act (Act) and FDA implementing regulations.

The omission or minimization of risk information in these promotional materials is a public health concern because Celebrex and Bextra are contraindicated for several patient populations, both products contain warnings of serious gastrointestinal (GI) effects and anaphylactoid reactions and Bextra contains an additional warning regarding serious, possibly life-threatening skin reactions. Celebrex and Bextra are associated with a number of serious risks, as stated in their respective PIs. (Related article: Treatment options for Vioxx, Celebrex, and Bextra patients)

The Guitar TV ad

Omission of (critical) information implies that there are no risks to the patient who takes Celebrex, which overstates the drug’s safety. (It) fails to offer options for persons who are uncomfortable with directly requesting additional prescription drug product information from their healthcare providers, persons without access to computers and the Internet, persons who are uncomfortable with actively requesting additional product information about a specific prescription drug by telephone, and persons concerned about providing phone numbers or other personal information in connection with their requests. (Related article: Americans scared after Vioxx recall)

The Arthritis Tips TV ad

(It) is a product-specific drug ad for Celebrex that is misleading because it omits important information about the drug’s safety and effectiveness and makes unsubstantiated effectiveness claims. The ad promotes Celebrex by identifying the drug by name at the beginning and end of the ad. Moreover, stating that Celebrex is presenting/bringing you arthritis tips clearly suggests that Celebrex is an arthritis treatment. (The) ad is misleading because it overstates the proven effectiveness of Celebrex for the treatment of “arthritis.” Celebrex is indicated only for relief of the signs and symptoms of OA and RA. Celebrex is not indicated for disease modification (i.e., altering the course of the progression of arthritis). Moreover, we are not aware of substantial evidence or substantial clinical experience demonstrating that treatment with Celebrex will prevent crippling effects or disability due to arthritis or prevent nursing home institutionalization of elderly patients with arthritis. Therefore, your Arthritis Tips TV ad greatly overstates the proven benefits of Celebrex. (Related article: Drug recall scams and deceptive advertising grows)

The print ad

(It) features the prominent headline “Strength They Can Stay With” and shows a chart comparing Celebrex, Ibuprofen and Naproxen, titled “6-Month Patient Persistency Rate.” Over the chart is the statement, “In a study of approximately 1 million patients, persistency rates of different OA/RA treatments were assessed at 6 months.” The tagline below the Celebrex logo in the print ad is “Proven strength that lasts.” The above referenced claims imply that Celebrex is more effective (i.e., stronger) than ibuprofen and naproxen for treatment of osteoarthritis or rheumatoid arthritis and that patients “stay with” or aremore compliant with Celebrex therapy than the compared products. We are not aware of substantial evidence or substantial clinical experience to support these claims. Therefore, the analyses do not constitute substantial evidence or substantial clinical experience demonstrating that OA/RA patients are more compliant with Celebrex or stay on Celebrex longer because it is more effective than other products for the treatment of OA or RA.

Bextra Direct Mail Brochure

The patient brochure, “How to Hit Arthritis Joint Pain Hard,” features safety claims and presentations that are misleading because they minimize the serious GI risks associated with Bextra therapy.

The totality of the graphic and the “stomach stays protected” safety claim are misleading because they suggest that Bextra provides significant protection from serious GI side effects. However, these safety claims are inconsistent with the Warning in the Bextra PI regarding serious and life-threatening GI side effects, including bleeding in the stomach and intestines. (Related article: Vioxx recall shows how FDA became toothless)

TV Infomercial

The 27-minute TV infomercial “On the Road to Joint Pain Relief” ad from Pfizer on arthritis and joint pain relief is a drug ad for Celebrex and Bextra that is misleading because it overstates its proven effectiveness and omits important information about the drugs’ safety and effectiveness. The infomercial points to and describes benefits from taking a specific prescription drug therapy from Pfizer, though it does not mention Celebrex or Bextra by name.

The infomercial also suggests that this drug is a breakthrough treatment (and the “right” treatment) offering superior effectiveness and safety over other arthritis treatments. The infomercial omits any risk information for Celebrex or Bextra. Therefore, the infomercial overstates the effectiveness of the drugs while minimizing, by complete omission, the risks. The infomercial features statements from healthcare providers and patient testimonials, two highly credible sources of information for consumers that greatly overstate the demonstrated benefits of Celebrex and Bextra. (Related article: Alternatives to Vioxx and Celebrex for pain relief)

We are not aware of substantial evidence or substantial clinical experience with Celebrex or Bextra demonstrating such effectiveness in these outcomes measures. We are not aware of any evidence showing that Celebrex or Bextra has superior effectiveness to nonselective NSAIDs. Indeed, none of the comparative studies with naproxen, ibuprofen, and diclofenac to-date has been designed to demonstrate superiority or a specified degree of similarity in a rigorous way. We are also not aware of any adequate and well-controlled studies evaluating whether Celebrex or Bextra is effective in patients who have previously failed non-selective NSAID therapies.

Furthermore, the infomercial portrays OTC therapies as posing safety risks, while there is no discussion of any risks for the treatment being promoted.The infomercial also fails to present a brief summary of necessary information related to side effects and contraindications or make adequate provision for the dissemination of approved product labeling in connection with the broadcast ad.

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