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FDA Sets New Celebrex Label

The Pfizer drug is also approved to treat ankylosing spondylitis.
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The Food and Drug Administration approved


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Celebrex as a treatment for ankylosing spondylitis, a form of arthritis that affects the spine, and the agency finished detailing the label changes that will accompany the drug.

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Celebrex is also used for patients suffering from osteoarthritis and adult rheumatoid arthritis, acute pain, menstrual pain and as a treatment for familial adenomatous polyposis, a rare condition that leads to colon cancer.

As expected, the FDA also completed the prescribing instructions for Celebrex for all approved uses, including additional warnings about potential cardiovascular and gastrointestinal risks, and the final label will contain a boxed warning. Pfizer said the FDA will require similar warnings for other older arthritis treatments like ibuprofen and naproxen.

Ankylosing spondylitis, which affects more than 400,000 Americans, is the sixth approved indication for Celebrex in the U.S. The condition usually strikes people between the ages of 17 and 35. Ankylosing spondylitis also can cause inflammation, pain and stiffness in other parts of the body such as the shoulders, knees, hips, ribs and feet.

The label addition for Celebrex follows a February meeting of an FDA advisory panel, which reviewed a number of selective and nonselective pain relievers. The panel recommended that stronger warnings be added to all selective COX-2 pain medicines, such as Celebrex, as well as to the older, nonsteroidal anti-inflammatory drugs. In addition, the panel recommended avoiding use of all NSAIDs and COX-2 selective medicines to treat pain associated with heart bypass surgery.

The label recommends that Celebrex be prescribed at the lowest effective dose for the shortest duration possible. Shares of Pfizer, a New York-based drug giant, were gaining 11 cents to $26.61.