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Another Arthritis Drug Poses Risks ; Research Links Pfizer's Celebrex to Heart Attacks and Strokes

Posted on: Sunday, 19 December 2004, 18:00 CST

NEW YORK Pfizer Inc. said it found an increased risk of heart attacks and strokes for patients taking high dosages of its top- selling arthritis painkiller Celebrex, the same problem that led to the withdrawal of its one-time competitor Vioxx.

The company said it has no plans to remove Celebrex from the market, but the disclosure on Friday sent Pfizer's shares tumbling because of fears that it could cripple sales of what had been the most-prescribed drug for treating arthritis.

Acting FDA Commissioner Lester Crawford said the government is advising physicians to consider prescribing drugs other than Celebrex to their patients.

"We're leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product," said Crawford, during a press briefing. "We do have great concern about this product (Celebrex) and the class of products."

But doctors have already been inundated with phone calls from worried patients and say they will curtail writing prescriptions for the drug.

Shares of Pfizer, a member of the Dow index and the world's largest pharmaceutical maker, plunged $3.23, or 11.15 percent, to $25.75 in late afternoon trading on the New York Stock Exchange. The decline wiped out almost $25 billion of Pfizer's market value.

The drug industry has already been under fire for numerous high- profile debacles: Merck & Co.'s withdrawal of Vioxx, the failure of Chiron Corp. to deliver half the country's flu vaccines, and disclosures that drug companies had stifled negative clinical trial data from studies examining anti-depressant use in children.

Both Celebrex and Vioxx are a type of drug called cox-2 inhibitors. Vioxx was pulled from the market in September because it doubled patients' risk of heart attack and strokes.

National Institutes of Health director Dr. Elias Zerhouni said that he ordered a full review of the more than 40 agency-supported studies involving cox-2 inhibitors.

News of the increased heart risk for patients using Celebrex came in one of two long-term cancer prevention trials.

The National Cancer Institute, which was conducting the study for Pfizer, said patients in the clinical trial taking 800 milligrams of Celebrex had a 3.4 times greater risk of cardiovascular events compared to a placebo. For patients in the trial taking 400 milligrams of Celebrex the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.

In the 2,000-patient study, 15 individuals taking 400 mgs, 20 patients taking 800 mgs and 6 patients on placebo suffered either a cardiac-related death, heart attack or stroke.

The study was intended to show whether Celebrex could prevent precancerous growths called polyps in patients that had already had at least one such growth.

Pfizer chairman and chief executive Hank McKinnell, who takes Celebrex, told CNN that he plans to continue using the drug.

Dr. Garret FitzGerald, a cardiologist at the University of Pennsylvania, said Pfizer's huge marketing push behind the drug accounted for its dramatic use. Last year, Pfizer spent $87.6 million to advertise Celebrex, according to media observers. It recently launched a new campaign for the drug and placed full-page ads in newspapers touting Celebrex's safety in the wake of the Vioxx recall.

Those safety claims may cause problems for the Pfizer. Citing recent company statements, including a Nov. 4 press release touting the drug's safety, U.S. Rep. Joe Barton, R-Texas, and U.S. Rep. John Dingell, D-Mich., asked Pfizer on Friday for documents regarding Celebrex and Bextra, the company's other Cox-2 inhibitor. They want to know what information Pfizer had about the NCI study when it made the safety statements.

Source: Columbian

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