Pfizer Inc.'s Celebrex and Bextra and Merck & Co.'s Arcoxia and Vioxx painkillers should have labels that warn patients with gastrointestinal or heart problems not to take the products, a European health regulatory panel recommends.
The EU's Committee for Proprietary Medicinal Products found that the drugs could be taken safely by most people, the agency said on its Web site. The London-based panel recommended the label changes and suggested the drugmakers also tell patients about possible skin rashes and hypersensitivity reactions.
Celebrex, Bextra, Arcoxia and Vioxx are among a family of painkillers called COX-2 inhibitors, marketed to treat arthritis.
In July 2002, French authorities asked the agency to assess the safety of the arthritis drugs. The panel makes recommendations to the European Commission, which usually acts on them within three months.
The agency also recommended that pregnant women not take drugs containing loratadine, such as Schering-Plough Corp.'s Claritin, because it can't rule out a link to birth defects in boys. The panel started looking at a possible connection in April 2002.