Pfizer is revising Celebrex and Bextra professional promotions at FDA's request to include suggestions that physicians consider alternative therapies on an individual patient basis.

FDA "requested the company change the information provided to physicians to reflect the recommendations FDA made encouraging physicians to consider alternative therapies as they evaluate their individual patient needs," the agency said Dec. 20.

Pfizer has agreed "to craft appropriate detailing to physicians that reflects the uncertainty of scientific data currently available," FDA added.

The revised promotional message also incorporates FDA's suggestion that patients be treated with the lowest effective dose of Celebrex.

FDA made the dose recommendation Dec. 17 after the Adenoma Prevention with Celecoxib trial sponsored by the National Cancer Institute demonstrated a 2.5-fold and 3.4-fold increase in cardiovascular risk compared to placebo at the 400 mg and 800 mg doses, respectively.

"If physicians determine that continued use is appropriate for individual patients, FDA advises the use of the lowest effective dose of Celebrex," the agency said.

Pfizer has also agreed to suspend all direct-to-consumer advertising for Celebrex while FDA obtains and evaluates "the new and conflicting scientific data on adverse events associated with the drug," FDA said.

The cardiovascular risk appears to have caught FDA and Pfizer off-guard; both previously said Celebrex was free of cardiovascular safety signals (¹ Also see "Celebrex Long-Term Safety Monitoring Results Reassure FDA" - Pink Sheet, 8 November, 2004., p. 14).

Pfizer aggressively defended the safety of Celebrex following the Sept. 30 withdrawal of Merck's Vioxx (rofecoxib). In the weeks after the withdrawal, Pfizer positioned celecoxib as the safest choice for pain (² Also see "Pfizer Goes On Offense With Celebrex: TV Ads, Study Proposal Stress Safety" - Pink Sheet, 25 October, 2004., p. 12).

Pfizer launched new DTC ads as part of its campaign to promote the safety of Celebrex. The campaign included an unbranded ad highlighting the risks associated with over-the-counter NSAIDs and a branded ad featuring an animated character with elbow pain after playing tennis.

In the wake of the APC trial results, the House Energy & Commerce Committee is asking Pfizer to justify claims it made about Celebrex' safety profile following the Vioxx withdrawal.

"We are concerned about public representations made by the company touting the safety of Celebrex during the fall of 2004," a Dec. 17 letter to Pfizer from Committee Chair Joe Barton (R-Tex.) and Ranking Member John Dingell (D-Mich.) states.

The committee notes that Pfizer defended Celebrex' cardiovascular safety while the APC trial "was being analyzed."

The letter specifically cites a Nov. 4 press release (titled "Pfizer Affirms Celebrex Safety") that the company issued in response to a Canadian media report linking the drug to 14 deaths.

"We are interested in learning what information the company had regarding the NCI-sponsored study cardiovascular data at that time," the letter states.

The committee is also asking Pfizer why the APC trial and a second study, the Prevention of Spontaneous Adenomatous Polyps trial, were halted in December, after preliminary reviews by the Data Safety & Monitoring Boards of the two trials determined in September and October that the trials could proceed.

Pfizer should supply all relevant safety information about both Celebrex and Bextra (valdecoxib), the letter states. In addition, the committee wants "all records relating to" Bextra's November label revisions, which included the addition of a "black box" warning about skin reactions and cardiovascular safety warnings (³ Also see "Bextra Meta-Analysis Affirms Safety Profile, Pfizer Tells Physicians" - Pink Sheet, 6 December, 2004., p. 10).

Pfizer is not sitting quietly on the sidelines as its COX-2 inhibitors continue to be the subject of negative media reports. The company is mounting an extensive public relations campaign to discuss its decision to continue marketing Celebrex that included appearances by CEO Hank McKinnell on several national news programs Dec. 19 and 20.

Pfizer Tells Doctors To Consider COX-2 Alternatives; DTC Ads Are Halted

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