NIH working on information on Celebrex use

The National Institutes of Health said on Friday it was working with the Food and Drug Administration to make sure the public has information “to make informed decisions” about the use of COX-2 inhibitors like Pfizer Inc.‘s Celebrex and Merck & Co.‘s withdrawn drug Vioxx.

“We are examining the use of these agents in all NIH-sponsored clinical studies. In addition, we are working closely with our colleagues at FDA to ensure that the public has the information they need to make informed decisions about the use of this class of drug,” NIH Director Elias Zerhouni said in a statement.

Meanwhile, acting FDA Commissioner Lester Crawford said on Friday that the agency has “great concerns” about Celebrex and other COX-2 inhibitors.

The FDA is “keeping all options open” on Celebrex, including the possibility of adding a black box warning about safety risks. Crawford said he expected to have more announcements about Celebrex in the next few days.

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Provided by ArmMed Media
Revision date: June 20, 2011
Last revised: by Andrew G. Epstein, M.D.