Pfizer's Celebrex arthritis drug scrutinised

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: Celebrex Recall

Crawford said the FDA would have more announcements about Celebrex in the next few days.

The NIH said it was reviewing all government grants for studying Celebrex and other COX-2 inhibitors.

If doctors do consider Celebrex appropriate for certain patients, they should prescribe the lowest possible dose, FDA officials said.

The drug industry has already been under fire for numerous high profile debacles: Merck & Co.'s withdrawal of Vioxx, the failure of Chiron Corp. to deliver half the country's flu vaccines, and disclosures that drug companies had stifled negative clinical trial data from studies examining anti-depressant use in children.

The National Cancer Institute, which was conducting the study for Pfizer, said patients in the clinical trial taking 800 milligrams of Celebrex had a 3.4 times greater risk of cardiovascular events compared to a placebo. For patients in the trial taking 400 milligrams of Celebrex the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.

In the 2,000 patient study, 15 individuals taking 400 mgs, 20 patients taking 800 mgs and 6 patients on placebo suffered either a cardiac-related death, heart attack or stroke.

Dr. Garret A. FitzGerald, who has been critical of cox-2 inhibitors said he believed the news has implications for cox-2 inhibitors such as those under development at Merck and Novartis. "I think the trial concludes the controversy about whether there is a class effect of these drugs. Now there is clear evidence of it," said FitzGerald. "You would need to believe the earth is flat if you thought this was just a coincidence."

http://www.reuters.co.uk/newsArticle.jhtml?type=businessNews&storyID=640773§ion=finance&src=rss/uk/businessNews

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