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Study Finds Heart Risks in Pfizer Painkiller Celebrex

Posted on: Monday, 10 January 2005, 12:00 CST

Pfizer said Friday that it had found an increased risk of heart trouble in some people taking higher dosages of Celebrex, its popular arthritis and pain relief drug.

The findings came three months after another pharmaceutical maker, Merck, withdrew the painkiller Vioxx, Celebrex's chief rival, because a study had found that Vioxx doubled patients' risk of heart attack and strokes.

Pfizer did not say whether it might pull Celebrex from the market, but Pfizer shares slid on the news of the study, down at one point to $21.99, before rebounding somewhat to close at $25.75 in New York, a drop of $3.23, or 11 percent. Pfizer reported $1.9 billion in revenue from Celebrex sales in 2003, according to data posted on its Web site. In October of this year, the first month after Vioxx's withdrawal, an estimated 2.34 million prescriptions were written for Celebrex, up from two million in September. That has ebbed somewhat, but it is estimated that Celebrex still accounts for about 11 percent of all new prescriptions written. Dr. Joseph Feczko, president of worldwide development for Pfizer, said patients taking Celebrex "should discuss appropriate treatment options with their health care professionals."

Pfizer emphasized that while the increased risk had been detected in one long-term cancer-prevention trial, a second trial had indicated no increased risk.

Nonetheless, Dr. Richard Hayes, a cardiologist at New York University, told Reuters that the new data "raises my concern about Celebrex and all the COX-2 inhibitors, so I will no longer be prescribing any of them." The studies were conducted for Pfizer by the National Cancer Institute. In one, patients taking 400 milligrams to 800 milligrams of the drug daily were found to have a risk of experiencing major heart problems that was 2.5 times greater than people who were not taking the drug. The other cancer study found no increased heart risk with patients taking 400 milligrams of Celebrex a day.

"These clinical trial results are new," Pfizer's chairman and chief executive, Henry McKinnell Jr., said in a statement. "The cardiovascular findings in one of the studies are unexpected and not consistent with the reported findings in the second study.

"Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world," he added.

The National Cancer Institute suspended the first trial in which some patients were shown to have an increased risk of heart disease.

Celebrex and Vioxx are in the same category of drugs, which have become widely prescribed because they were initially shown to be safer for the stomach than some older pain relievers, by lowering the rate of ulcers and gastrointestinal bleeding.

Pfizer also produces the painkiller Bextra, another COX-2 inhibitor. Last week, the U.S. Food and Drug Administration said it would require a new warning label on Bextra because of potential heart problems associated with the use of that painkiller in people who had recently had heart bypass surgery.

The agency said that "results from a new study of more than 1,500 patients who had just had cardiac surgery show that patients treated with Bextra for pain were more likely to have heart and blood- clotting problems than other patients who did not receive any drug." The problems included heart attack, stroke and blood clots in the legs and the lungs, it said.

The agency is convening a panel in February to review all COX-2 inhibitors.

Pfizer said that it immediately shared results of the study with the agency and that it would "continue to work with FDA on the company's plans to sponsor a major clinical study to further assess Celebrex in osteoarthritis patients at high risk for cardiovascular disease." The Standard & Poor's ratings service said Friday that it would not change Pfizer's financial rating in light of the new findings from the one cancer trial. S&P noted that "no such increase was observed in two other ongoing long-term trials involving Celebrex" that used dosages of 400 milligrams.

"The drug is generally prescribed at 100 milligram to 400 milligram doses for arthritis pain," S&P said. "Pfizer is currently analyzing the data regarding the drug."

Source: International Herald Tribune

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