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Study Finds Celebrex Heart Risk ; Pfizer Doesn't Plan Recall, but Prescription Cut Seen

Posted on: Monday, 20 December 2004, 15:00 CST

Pfizer Inc. said Friday that its painkiller Celebrex - a widely prescribed arthritis treatment - more than doubled patients' risk of heart problems in a clinical study.

The announcement, 11 weeks after Merck & Co. Inc. recalled the similar drug Vioxx, left patients and doctors scrambling to figure out how to safely manage chronic pain.

Dr. Jeff Pavell of Englewood Hospital and Medical Center said he will "think twice" about prescribing Celebrex, even for the short term, "for patients with increased cardiac risk - hypertension, congestive heart failure, coronary artery disease -or kidney [problems]." The study was examining Celebrex's potential as a long- term treatment for preventing precancerous polyps in the colon.

Pfizer, which said it became aware of the results Thursday night, announced no plans to recall Celebrex, but many doctors appear likely to cut back sharply on prescribing it.

"We thought Celebrex was safe and the problem was just with Vioxx," said Dr. Richard Hayes, a New York cardiologist who is telling his patients to stop using Celebrex. "The problem is more complex than we thought."

Calling Celebrex "one of the most popular drugs out there," pharmacy manager Manny Ramirez of J&J Pharmacy in Teaneck said, "I anticipate a huge impact" from the study.

Dr. Joseph Feczko, president of worldwide development for Pfizer, said sales of Celebrex will continue because "it has not shown in totality that it increases the risk of heart attacks."

In addition, the company noted that the troubling results came in a study in which Celebrex was given at larger dosages than the dosages given to typical arthritis patients.

The study, by the National Cancer Institute, was halted after the heart risk was discovered. But a companion study, as well as other research, found no increased risk of heart trouble, Pfizer said.

Friday's announcement is likely to be costly for Pfizer, if Merck's experience is any guide. The Sept. 30 recall of Vioxx has led to lawsuits, lower profits and announcements of job cuts at Merck.

Investors reacted strongly to the news Friday, knocking 11 percent off Pfizer's stock price. It closed at $25.75, down $3.23. Like Merck, which is based in Whitehouse Station, New York-based Pfizer is a widely held stock and one of the 30 stocks making up the Dow Jones industrial average.

Both Celebrex and Vioxx are a type of drug called cox-2 inhibitors, which were designed to be easier on the stomach than other painkillers such as aspirin.

In the nine months ending in September, worldwide sales of Celebrex more than doubled from the same period a year earlier to $2.29 billion, accounting for 6 percent of Pfizer's total sales of $37.59 billion in the period. By contrast, Vioxx accounted for 11 percent of Merck's $22.5 billion in revenue last year.

Sidney Wolfe, head of Public Citizen's Health Research Group, on Friday called on the Food and Drug Administration on Friday to ban Celebrex and another Pfizer drug, Bextra, also a cox-2 inhibitor. Earlier this month, the FDA said it was adding a warning to Bextra labels, noting a risk of heart problems in users who have recently had heart bypasses.

And the New England Journal of Medicine on Friday printed a letter from three doctors urging their colleagues not to prescribe Bextra because of the cardiovascular risks.

One of the authors of the letter, Dr. Marie Griffin, an epidemiologist and drug safety expert at Vanderbilt University, said the Celebrex findings suggest that all cox-2 drugs have similar risks. But she said the safety concerns may apply only to patients taking Celebrex at high doses.

Lawyers predicted a flood of lawsuits in the wake of Pfizer's announcement.

"The issue is going to be when they knew what they knew, and how they acted on it," said Kenneth M. Labbate, a lawyer who defends drug companies from product liability lawsuits.

"And was the product designed properly? And were the warnings that accompanied the product sufficient?" said Labbate, who is with the law firm Ohrenstein & Brown in New York.

Paul J. Pennock, a New York lawyer who represents plaintiffs in such cases, said Pfizer may have had earlier hints that Celebrex could be dangerous.

"You would have had signals in clinical trials," said Pennock, of the law firm Weitz & Luxenberg, who expects to sue Pfizer on behalf of patients who took Celebrex. "I think we're going to get into this case and find that Pfizer knew a lot more than they were telling people for the last several years."

Several investment analysts downgraded Pfizer stock in the wake of the announcement.

"While we had been cautious already on the cox-2 market in light of Vioxx, this news is likely to significantly impact market growth," wrote Adam Greene of First Albany Capital, which downgraded Pfizer stock from "strong buy" to "neutral" Friday.

Sena Lund, an analyst with Cathay Financial, also downgraded the stock, but said Pfizer's situation is different from Merck's. For one thing, he said, the studies on Celebrex are mixed about the risk of cardiovascular problems. In addition, the problem seemed to turn up at higher dosages than most arthritis patients use, Lund said.

The pharmaceutical industry has faced hard times recently. Patents on several top-selling drugs have expired recently or are set to expire soon.

And on Friday, AstraZeneca's stock dropped after it announced that its lung cancer drug, Iressa, failed to increase survival rates in clinical trials. Eli Lilly stock also took a hit after it announced that its attention-deficit disorder drug Strattera could cause liver damage.

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This story contains material from The Associated Press.

E-mail: groves@northjersey.com and lynn@northjersey.com

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Source: Record, The; Bergen County, N.J.

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