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Celebrex Increases Risk of Heart Attacks, Pfizer Says

Posted on: Saturday, 18 December 2004, 00:00 CST

Dec. 18--CHICAGO -- Pharmaceutical giant Pfizer Inc. said Friday high dosages of its drug Celebrex, the top-selling brand name arthritis prescription in the United States, has been found to significantly increase the risk of heart attacks for those who take it.

Celebrex is in the same drug class as Vioxx -- the pill Merck & Co. pulled less than three months ago citing cardiovascular risks -- and, in fact, enjoyed a boost in sales in recent weeks from former Vioxx users.

Although Pfizer said it has no plans to remove Celebrex from the market, an embattled U.S. Food and Drug Administration urged physicians and patients to "evaluate alternative therapies" such as widely used over-the-counter treatments like ibuprofen or naproxen.

"We do have great concerns about this product and this class of products," said acting FDA Commissioner Lester Crawford. "We are leaving all regulatory options open."

Pfizer is keeping the drug on the shelves because the new study conflicted with "a large body of data that we and others have accumulated over time in which an increased risk of serious cardiovascular event, even in higher-than-recommended doses, had not been seen," according to Dr. Joseph Feczko, president of worldwide development for Pfizer.

Friday's revelation prompted consumer groups, physicians and members of Congress to again blast the FDA for waning public confidence in U.S. drug safety measures. Beyond Vioxx, the drug industry has come under fire for numerous other high-profile debacles in recent months, including the failure of Chiron Corp. to deliver half the country's flu vaccines and disclosures that drug-makers stifled negative clinical data from studies examining anti-depressant use in children.

"At this point, no one can say with confidence whether the worst drug safety problems are behind us or ahead of us," said Sen. Chuck Grassley, R-Iowa, chairman of the Senate Finance Committee, which oversees many key health issues. "Right now, we have a situation where the public is left wondering when the next shoe might drop when it comes to drug safety

Dr. Calvin Brown, an associate professor of rheumatology at Rush University Medical Center in Chicago said the Celebrex warning is a symptom of the country's poor performance in monitoring drug safety on an ongoing basis.

"If we had been collecting safety data on Celebrex and any other drug all along after it was launched, we would have more definite answers," he said.

To be sure, in the recent Vioxx and Celebrex studies, indications of troubling health risks were forwarded by drug-makers who were studying the arthritis medicines for other uses -- not from follow-up studies by government regulators.

On Friday, the FDA said patients in a cancer prevention trial who took two 400 milligram doses of Celebrex a day had a 3.4 times greater risk of cardiovascular events than those who took a placebo. For patients in the trial taking 200 mg of Celebrex twice a day, the risk was 2.5 times greater, the agency said. The average duration of treatment in the trial was 33 months, the FDA said.

Pfizer is currently running two Celebrex-related trials tracking 3,600 hundred patients over a five-year period. Some have already spent four years with the trial and about 2,400 have had a cardiovascular analysis after two years of treatment.

"A similar ongoing study comparing Celebrex 400 mg once a day versus placebo, in patients followed for a similar period of time, has not shown increased risk," the FDA said.

For its part, Pfizer said it hadn't expected the results. "Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world," said Hank McKinnell, Pfizer chairman and chief executive officer.

Pfizer's disclosure, which emerged during a study of Celebrex as a cancer prevention drug, jarred investors of the world's largest drug-maker on fears sales could be crippled.

Shares of Pfizer plunged more than 11 percent, or $3.23 a share, to $25.75 Friday in heavy trading on the New York Stock Exchange. The New York-based drug-maker lost more than $25 billion in market value -- a number larger than the size of most publicly traded Chicago area companies.

Celebrex, developed by the former G.D. Searle & Co. of Skokie, is the 12th-best selling drug in the United States with annual sales of nearly $3 billion, according to the most recent information from health information firm IMS Health.

Sales rose even higher after Pfizer ramped up advertising when Merck removed Vioxx from the market Sept. 30 in a successful effort to capture that troubled drug's market share.

Vioxx was the second-most-prescribed arthritis drug, trailing Celebrex, in a class known as Cox-2 inhibitors. Cox-2s were hailed when first launched five years ago as "super aspirin" that could be used longer than older remedies because they did not harm the lining of the stomach as do aspirin or ibuprofin, which are known as "non-steroidal anti-inflammatories."

The third and only other Cox-2, Bextra, also sold by Pfizer, was given a warning label by the FDA just last week advising those taking the drug about possible severe skin reactions and increased cardiovascular risks to heart surgery patients.

Doctors said Pfizer drug sales representatives inundated their offices with studies and marketing materials after Vioxx was taken off the market in an effort to convince physicians to continue prescribing Celebrex, a drug prescribed to more than 27 million people in the United States since it was launched in 1999.

"A lot of us were skeptical (of the Pfizer sales reps)," said Dr. Daniel Derman, president of the Northwestern Memorial Physicians Group, a primary-care practice of more than 70 physicians.

Derman, an internist, said physicians are moving most patients to older arthritis medicines or even over the counter products like Motrin, Naprocin or Aleve. And for patients with stomach problems, doctors are urging them to also take heartburn medications like Prilosec.

Still, some doctors believe it is okay for patients to use Celebrex or Bextra if they first consult their physician who may allow them to take the drugs if they are younger and otherwise healthy. Yet, doctors say they are getting mixed signals because Pfizer has been studying Celebrex as a benefit for patients with cardiovascular problems.

"It's really, really confusing," Rush's Brown said. "While (Pfizer) has a study that raises concerns about heart safety, there were earlier studies that showed not only was Celebrex safe but it was protective against cardiovascular events."

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PFE, MRK, CHIR,

Source: Chicago Tribune

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