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Pfizer Says New Study Affirms Cardiovascular Safety of Celebrex?

December 21st, 2004 · No Comments

Pfizer, the world’s largest drugmaker, today said the National Institutes of Health has reported in an Alzheimer’s Disease prevention study that there was no increased cardiovascular risk seen in elderly patients taking its blockbuster arthritis and pain relief drug Celebrex (400 mg daily) for up to three years.

However, the NIH on Monday said that research investigators suspended, the use of, two drugs, Aleve (220 mg twice a day) and Celebrex, celecoxib, (200 mg twice a day), in a large, three-arm, national Alzheimer’s disease prevention trial sponsored.

“Although no significant increase in risk for celecoxib was found in this trial, the use of these drugs in the study was suspended in part because of findings reported last week from a National Cancer Institute (NCI) trial to test the effectiveness of celecoxib in preventing colon cancer,” the agency said.

Last week, Pfizer and the National Cancer Institute 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.

The Food and Drug Administration on Friday asked Pfizer to suspend direct-to-consumer advertising on Celebrex while the agency evaluates the new and conflicting scientific data on adverse cardiovascular events associated with the drug. FDA also requested the company change the information provided to physicians to reflect the recommendations the FDA made encouring physicians to consider alternative therapries as they evaluate their individual patient needs.

Pfizer agreed to suspend advertising on Celebrex and to craft appropriate detailing to physicians that reflects the uncertainty of scientific data currently available.

(via PR Newswire)

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Tags: Celebrex

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