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Celebrex Linked to Higher Risk of Heart Attack, Pfizer Says

Source: PR Newswire
Published: December 16, 2004

Celebrex, the popular arthritis and pain relief drug, increases some patients' risk of heart attack, Pfizer, the world's largest drugmaker, said after receiving new information yesterday from an analysis of two long-term cancer trials.

Pfizer and the National Cancer Institute on Thursday stopped an ongoing clinical trial investigating a new use of Celebrex because of an increased risk of heart attack in patients taking Celebrex versus taking a placebo (sugar pill).

Celebrex is part of the same family of drugs called COX-2 inhibitors as Bextra (also made by Pfizer) and Vioxx, which was pulled from the market by Merck & Company on September 30, 2004, after a study confirmed that it increases a patients' risk of heart attack and stroke.

Patients in the clinical trial taking 400 mg. of Celebrex twice daily had a 3.4 times greater risk of heart attack compared to placebo. For patients in the trial taking 200 mg. of Celebrex twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.

"These clinical trial results are new," Hank McKinnell, Pfizer chairman and CEO, said. "Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world."

Officials at the Food and Drug Administration said the agency has seen only the preliminary results of the studies. They said the FDA will obtain all available data on these and other ongoing Celebrex trials as soon as possible and will determine the appropriate regulatory action.

Celebrex is approved for use in the United States for the treatment of arthritis and pain, at recommended doses of 100mg to 200mg daily for osteoarthritis and 200mg to 400mg a day for rheumatoid arthritis. It is also approved for a rare condition called familial adenomatous polyposis in doses up to 800mg per day.

" Patients being treated with Celebrex should discuss appropriate treatment options with their healthcare professionals," Dr. Joseph Feczko, president of worldwide development for Pfizer, said. "Physicians should factor this new information, as well as ulcer risks and gastrointestinal bleeding seen with traditional NSAIDs, into their prescribing decision."

The two studies, which are following patients over a five-year period, have enrolled a total of about 3,600 patients, some of whom have participated for more than four years. Pfizer estimates that about 2,400 patients evaluated in the cardiovascular analysis have completed two years of treatment.

A third long-term study involving Celebrex in patients at high-risk for Alzheimer's disease is also under way with about 2,000 patients enrolled, about 750 of whom are on 400mg per day of Celebrex. As with the cancer studies, this study is monitored by independent safety experts who meet regularly to assess adverse events. A review by this board as recent as December 10 did not result in any recommendations to change the conduct of this study.

Read Full Story at PR Newswire

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