The Pharmaceutical Journal
Vol 268 No 7203 p861-867
22 June 2002

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FDA removes celecoxib’s gastric protection claim

The United States Food and Drug Administration has told Pharmacia, the manufacturer of the cyclo-oxygenase (COX) 2 inhibitor Celebrex (celecoxib), that it can no longer make the claim that the product protects arthritis patients against gastric damage.

The FDA move comes in response to a BMJ editorial criticising CLASS (celecoxib long-term arthritis safety study), the key study into the safety of celecoxib, saying it was "flawed" and contained "serious irregularities" (PJ, 1 June, p755).

In a statement issued earlier this month, the FDA agreed that CLASS did not show a safety advantage in upper gastrointestinal events for celecoxib compared with either ibuprofen or diclofenac. "The agency concluded that the drug labelling for Celebrex should continue to include the standard warning for doctors and their patients about risks associated with all non-steroidal anti-inflammatory drugs, including risks of GI ulceration, bleeding and perforation."

However, the FDA also determined that data on the safety of celecoxib should be incorporated into the drug's labelling. "Despite the high dose [of celecoxib] used, the rates of hypertension, oedema, and serious adverse events, including cardiovascular adverse events (such as heart attacks) were no higher in Celebrex-treated patients compared with ibuprofen– or diclofenac- treated patients."

The statement is published on the FDA website.

A spokeswoman for the National Institute for Clinical Excellence says the institute has no plans to change its guidance of last year, recommending the drug's use in patients needing NSAIDs but who are at high risk of GI damage.

A statement from Pharmacia UK says: "The revised prescribing information includes additional GI safety data from CLASS and reaffirms the GI and cardiovascular safety profile of Celebrex."