The US FDA has called for new boxed warnings and medication guides for most nonsteroidal anti-inflammatory drugs (NSAIDs) to highlight the potential for increased cardiovascular risks and gastrointestinal bleeding.
The agency specifically mentioned celecoxib (Celebrex®) made by Pfizer inc.
The company, who has also been asked by the FDA and European regulators to withdraw its cyclo-oxygenase-2 inhibitor valdecoxib (Bextra) from the market amid concerns regarding its safety, said it would work with the agency on its new recommendations.
"Pfizer and the FDA plan further discussions regarding the precise content of the Celebrex label," the company said in a statement. "Pfizer has accumulated extensive Celebrex clinical data over the past 10 years involving more than 40 000 patients."
In addition, the US FDA has asked the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks and potential skin reactions.
This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004.
Reference
FDA press release 7th April 2005, 'FDA announces series of changes to the class if marketed non-steroidal anti-inflammatory drugs'
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