Celebrex gets another indication.
NEW YORK -- The Food and Drug Administration has approved the use of Pfizer Inc.'s Celebrex to treat symptoms of ankylosing spondylitis, a form of arthritis that affects the spine. The drug has heretofore been used to combat the pain of osteo arthritis and adult rheumatoid arthritis, acute pain and menstrual pain.
The FDA also finalized the label instructions for all approved uses, including additional warnings about potential cardiovascular and gastrointestinal risks. Similar warnings will be required for such over-the-counter analgesics as ibuprofen and naproxen.
Ankylosing spondylitis affects over 400,000 Americans, usually striking people ages 17 to 35 in contrast to other forms of arthritis, which typically afflict older people. The ailment is about as common as rheumatoid arthritis and can cause inflammation, pain and stiffness in the shoulders, knees, hips, ribs and feet.
"With this new indication, Celebrex offers physicians a new treatment option for this difficult-to-treat patient population," says Joseph Feczko, chief medical officer for Pfizer. "The inflammation associated with ankylosing spondylitis can cause such severe pain that people who suffer from this condition cannot perform even simple, everyday activities like walking and may have trouble attending school or work."
The label warning resulted from a meeting of an FDA advisory panel that recommended stronger warnings be added to all selective COX-2 pain medicines and nonsteroidal anti-inflammatory drugs (NSAIDs).
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|Title Annotation:||Pfizer Inc. gets approval|
|Article Type:||Brief Article|
|Date:||Aug 22, 2005|
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