Celebrex Gets New Label Warning

August 2, 2005-- Posted at 2:50 PM CDT

The U.S. Food and Drug Administration has added new warnings to the label for Pfizer's Celebrex, reflecting concerns over the arthritis drug's potential cardiovascular risks, the Associated Press reported.

The new labeling recommends that Celebrex be prescribed at the lowest effective dose for the shortest possible duration. Celebrex belongs to a class of painkillers called Cox-2 inhibitors, of which two other drugs -- Merck's Vioxx and Pfizer's Bextra -- have been pulled from the market due to studies linking long-term use of the drugs to increased risks of heart attack and stroke.

The label will also include a warning that long-term use of Celebrex, like older painkillers, could cause gastrointestinal bleeding and ulcers, the AP said.

In related news, the FDA on Monday approved a new use for Celebrex as a treatment for arthritis of the spine, a condition called ankylosing spondylitis. The condition affects some 400,000 Americans, typically young men, the AP said.

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