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FDA Warns of Naproxen

Dec 21, 2004 | There's more pain for drugmakers and more worries for drug users.

The Food and Drug Administration is now warning about heart risks related to the use of Naproxen, a popular pain killer sold over the counter under various names.

The latest shock to the industry came Monday night when federal regulators disclosed that the National Institutes of Health last Friday halted a drug study involving certain anti-inflammatory drugs and patients at risk for Alzheimer's disease.

One of the drugs involved, Naproxen, is sold in generic form but is also the key ingredient in such brands as Aleve, sold by Germany's Bayer and Naprosyn, sold by a subsidiary of Switzerland's Roche.

The NIH study in question also involved Celebrex, Pfizer's prescription drug approved for treating arthritis which is now the subject of its own safety concerns after the company last Friday disclosed that it had raised questions about increased cardiovascular risk in one of two clinical trials for cancer patients. Pfizer has pulled its consumer Celebrex ads but has maintained its position that the drug is safe for its original FDA-approved use.

Celebrex had previously come under scrutiny because it comes from the same class of COX-2 inhibitors as Vioxx, the painkiller Merck pulled from the market in late September because of heart attack-risk issues.

Celebrex, Vioxx and Pfizer's other painkiller Bextra, which has also come under fire, are in a broader group of drugs that include Naproxen, ibuprofen and aspirin.

The FDA warning advises consumers to use Naproxen-based drugs for no longer than 10 days and not diverge from label instructions.

Bayer shares were down 11 cents, or 0.3%, to $33.50 in premarket trading Tuesday.

Pfizer shares were up 34 cents, or 1.4%, to $24.63, having been pounded down to new 52-week lows after the latest Celebrex development Friday. They closed at $28.98 last Thursday before the disclosure.

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