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Arthritis drugs under review by Europeans

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LONDON — The European Medicines Agency, a London-based regulator that monitors pharmaceutical safety, is conducting a review of pain relievers in the wake of the withdrawal of the arthritis drug Vioxx from the market.

The agency will examine a variety of the anti-inflammatory drugs known as COX-2 inhibitors and study their effects on cardiovascular health. The U.S. Food and Drug Administration is also reviewing COX-2 drugs, which take their name from cyclooxygenase, an enzyme in the body that contributes to pain and inflammation.

Merck, the maker of Vioxx, withdrew the drug from the market on Sept. 30, after a company study showed that trial subjects who had taken Vioxx for more than 18 months had double the risk of heart attacks and strokes.

The European agency said on Friday that it was studying the other COX-2 drugs on the market or in development, calling the action a "precautionary measure." Its review is expected to be completed in five or six months.

"We'll be putting questions to the companies" that manufacture these drugs, said Noel Wathion, who heads a unit that evaluates drugs for human use. Companies will be asked to "submit all the available data" they have about these drugs that relate to cardiovascular health, he said.

When the review is completed, the agency will issue a report to the European Commission, the year-round administrative arm of the European Union. Recommendations could range from advising that no changes be made, to urging labeling changes, to advising that the commission withdraw manufacturers' rights to market these products, Wathion said.

The unit conducting the review studied the safety of COX-2 drugs in 2003 and did not recommend changes, but it is now looking at all newly available data.

Celecoxib, sold as Celebrex, is made by Pfizer and used by 27 million patients in the United States. Pfizer said in a statement on Sept. 30 that it was "confident in the long-term cardiovascular safety" of the drug. The company also sells valdecoxib under the brand name Bextra. Merck's etoricoxib drug, Arcoxia, is in the advanced stages of development. Also in advanced development is lumiracoxib from Novartis, to be sold as Prexige, which has been approved for use in Britain.

The European Medicines Agency, a decentralized body of the European Union, relies in part on a network of 3,000 scientists and experts to conduct studies and make decisions.