New Celebrex Label Approved

By Carol Kennedy

Published on August 02, 2005

The new label will include an indication for treatment of ankylosing spondylitis, a form of arthritis affecting the spine, as well as warnings about possible cardiovascular and gastrointestinal risks. The new label will also recommend that Celebrex be prescribed at the lowest possible dosage for the shortest duration of time.

Celebrex, manufactured by Pfizer, has been under review by an FDA advisory panel. The panel reviewed several selective and nonselective pain relievers and recommended stronger warnings be added to all selective COX-2 pain medications, including Celebrex. The panel also recommended that COX-2 medications be avoided when treating pain resulting from heart bypass surgery.

A Pfizer spokesperson said that the FDA will require similar warnings for older arthritis drugs such as ibuprofen and naproxen.

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