Actions on NSAIDS
Posted by admin on January 10, 2010 under Uncategorized | 
33 Comments to Read
On April 7, 2005, FDA announced several vital changes that pertain to the marketing of non-steroidal anti-inflammatory drugs (NSAIDs). FDA has questioned that one product be withdrawn from the market, and is requiring stronger warnings in the labeling for the other products. This is a continuation of the process that started several months ago with Vioxx (rofecoxib), when Merck withdrew that product from the market because of concerns about adverse cardiovascular events. These later actions are being taken because of concerns about other NSAIDs. It’s vital to know that the new actions don’t just apply to the COX-2 selective inhibitors. They apply to both the COX-2 inhibitors and to other, non-selective NSAIDs, and they apply to both prescription and non-prescription products. FDA questioned the manufacturer of one of the COX-2 inhibitors, Bextra (valdecoxib), to withdraw it from the market based on concerns about cardiovascular events, and serious skin reactions. In its choice about Bextra, FDA noted the lack of adequate data on the cardiovascular safety of this drug when it’s used chronically, and also reports of serious skin reactions, including deaths. Another factor was the lack of demonstrated advantages of Bextra over other NSAIDs. That leaves just one COX-2 inhibitor, Celebrex (celecoxib), still on the market. FDA chose that the benefits of Celebrex outweigh the risks, provided that patients are properly selected and informed. But FDA is requiring that …
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