FDA issues COX-2, NSAID public health advisoryThe FDA issued a public health advisory on Thursday summarizing the agency's recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including COX-2 drugs, both linked to increased heart risks in recent weeks.
The advisory was issued as an interim measure, pending further agency review of data that continues to be collected on the drugs.
The FDA recommended that doctors consider emerging information on the Pfizer drugs Celebrex and Bextra and Merck's Vioxx when prescribing COX-2 selective agents. All three drugs have been tied to cardiovascular events in clinical trials.
The advisory also asks doctors to consider patient risks when recommending or prescribing NSAIDs and advises consumers to take OTC NSAIDs in accordance with label directions. Clinical trial results made public this week established a link between naproxen, the main compound in Bayer's OTC NSAID Aleve, and increased heart risk.
The FDA said it is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra and naproxen, and other data for COX-2 and NSAID products, to determine whether additional regulatory action is needed.
An FDA advisory committee meeting is planned for February, the FDA said.