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Clinical Trial Links Celebrex to Heart Risk

Posted on: Monday, 20 December 2004, 18:00 CST

Dec. 18--In an announcement that many doctors were waiting for, Pfizer Inc. said its top-selling painkiller Celebrex -- which is similar to Vioxx -- caused an increased risk of heart attacks when used in high doses during a clinical trial.

But Pfizer said it has no plans to take Celebrex off the market. The U.S. Food and Drug Administration has not made a decision about the drug but expects to do so in the next few days.

Celebrex is the most prescribed drug for treating arthritis. Patients taking Celebrex should talk to their physicians and consider alternatives to the drug, said Dr. Lester Crawford, acting commissioner of the FDA.

New York-based Pfizer is closely watched in Michigan because it maintains several operations and employs about 9,500 people in the state, including one of its largest research hubs in Ann Arbor.

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

The National Cancer Institute, which conducted the study for Pfizer, suspended the use of Celebrex after discovering that patients taking 200 milligrams of the drug twice a day were more than twice as likely to experience major heart problems than those who took a placebo.

The risk increased to 3.4 times for patients who took 400 mg of the drug twice a day.

A separate cancer study found no increased heart risk with patients taking one 400-mg dose of Celebrex per day.

Pfizer conducted the trials as part of an effort to find a new application for the drug.

The company decided Friday that there isn't enough evidence to take Celebrex off the market.

Dr. Joseph Feczko, president of worldwide development for Pfizer, said that sales of Celebrex will continue because "it has not shown in totality that it increases the risk of heart attacks." He said Pfizer still hadn't seen the data from the study so he couldn't speculate on how the two trials could have such different outcomes.

He added that the company was still planning to go ahead with a previously announced study to see whether Celebrex could actually help patients at high risk of heart attacks.

Celebrex is the third medication of its type that has prompted concerns. Pfizer warned doctors last week about heart risk linked to its other arthritis medication, Bextra. In September, Merck & Co. took its painkiller Vioxx off the market for similar reasons.

The U.S. House Energy and Commerce Committee, which is investigating Merck's withdrawal of the Vioxx painkiller, asked Pfizer on Friday for documents related to Celebrex.

While doctors expected news about Celebrex, some hoped for something more definitive.

"We were all wondering if this was going to happen. It really hasn't happened in a dramatic way, so there's still uncertainty," said Dr. James Leisen, chief of rheumatology at Henry Ford Hospital in Detroit.

Celebrex, Bextra and Vioxx are a type of drug called cox-2 inhibitors, which are popular because of their effectiveness in treating arthritis and other ailments without causing stomach pain.

"Everyone thinks those drugs are more effective -- they're truly not. They protect guts better," said Margo Farber, manager of drug information services for the Detroit Medical Center.

Alternative painkillers such as Advil and Motrin, with ibuprofen, are just as strong as cox-2 inhibitors, Farber said, but don't protect against stomach pain.

After Merck took Vioxx off the market, the DMC limited the use of Celebrex at its hospitals to short-term uses such as postoperative pain. Farber said the DMC is considering halting use of the drug altogether.

Cardiologist Dr. George Hanzel of Beaumont Hospital in Royal Oak is planning a study of 6,000 to 9,000 cardiac patients who have been prescribed painkillers, including Celebrex.

"I would discourage high doses of Celebrex, without a doubt. More information, more research is needed before we can come down strongly on this," Hanzel said.

The news worries Jane Ramsden, 52, of Troy, who calls Celebrex a "wonder drug."

"It broke my heart because it's been the greatest drug," she said.

Ramdsen's podiatrist prescribed Celebrex for a constant sharp pain in her heel a year and a half ago. The pain went away almost immediately after taking the drug, she said.

Celebrex is one of Pfizer's top five money makers, taking in $2.29 billion in revenue during the first nine months of the year.

Shares of Pfizer dropped $3.23, or 11 percent, to $25.75 on Friday on the New York Stock Exchange.

The Associated Press and Bloomberg contributed to this report.

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PFE, MRK,

Source: Detroit Free Press

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