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FDA To Hold Hearings On Controversial Painkillers

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The Food and Drug Administration will hold a three day long advisory panel meeting beginning Wednesday to examine claims about the dangers of painkillers such as Celebrex, Bextra and naproxen (sold in stores as Aleve). Celebrex and Bextra, both manufactured by Pfizer, are known as Cox-2 inhibitors.

The meeting will also discuss the recent removal of Vioxx from the market due to safety concerns. A link was found between Vioxx and an increased risk of heart attacks and strokes. As a result, Merck & Company withdrew the drug from the market.

This week's meeting will determine the future of arthritis pain relief for the foreseeable future. After hearing testimony, the advisory panel may decide to ban some of these medications altogether or may just request that tougher warning labels be placed on them. It is also possible that no changes could be recommended. Pfizer sold $4.5 billion worth of Celebrex and Bextra last year alone so a lot is at stake.

Also at stake at this week's meeting is how the FDA is perceived by the public at large. The organization has come under scrutiny in recent months for its alleged failure to act as a watchdog for consumers. Critics charge that the FDA has not protected consumer safety enough and has rushed drugs into the market without adequate testing in order to aid pharmaceutical companies.

'It can define how FDA is going to be looking at safety issues going forward,' said Sena Lund, a stock analyst with Cathay Financial LLC.

So while drug companies and the FDA struggle to determine what stays on the market and how much of a drug should be taken, arthritis sufferers are stuck in the middle, waiting for answers.

Brad Kurtzberg



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