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FDA: Drug Can't Be Labeled As Safer

Jun 8, 2002 | AP

The Food and Drug Administration ruled that the popular arthritis drug Celebrex can't be labeled as safer for the stomach than cheaper anti-inflammation drugs.

The drug's manufacturer, Pharmacia Corp., had paid for a clinical trial that found Celebrex was safer than ibuprofen and diclofenac because it caused fewer ulcers and ulcer complications.

The Peapack, N.J.-based company had submitted the study to the FDA hoping to have its label reflect what it says is a superior safety profile. The company said in a statement after the decision Friday that Celebrex users who didn't also take aspirin had a lower frequency of ulcers that had complications or symptoms than people who take the cheaper drugs.

A recent study by Express Scripts Inc., a pharmacy benefits firm, found the cheaper medications would likely be just as effective as Celebrex.

Celebrex was the second most advertised drug in the United States last year. Pharmacia spent $130 million to market it, which had sales of $3.1 billion.

A month's supply of Celebrex costs about $80 while a month's supply of ibuprofen is about $15.


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