The US Food and Drug Administration has approved Pfizer’s selective COX-2 inhibitor Celebrex (celecoxib) for the relief of the signs and symptoms associated with ankylosing spondylitis, a form of arthritis that affects the spine. Celebrex is already indicated for patients suffering from the pain of 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.

Pfizer has accumulated extensive clinical data relating to Celebrex over the past ten years involving more than 40,000 patients worldwide. As expected, the FDA also finalized the prescribing instructions, or label, for Celebrex for all approved uses, including additional warnings about potential cardiovascular and gastrointestinal risks. The FDA also will require similar warnings for other older arthritis treatments like ibuprofen and naproxen, said a company release.

Ankylosing spondylitis, which affects over 400,000 Americans, becomes the sixth approved indication for Celebrex in the United States. Unlike other forms of arthritis that typically affect older people, ankylosing spondylitis usually strikes between the ages of 17 and 35. Approximately as common as rheumatoid arthritis, ankylosing spondylitis also can cause inflammation, pain and stiffness in other areas of the body such as the shoulders, knees, hips, ribs, and feet.

The final label contains a boxed warning of potential cardiovascular and gastrointestinal risks for Celebrex that will be consistent with warnings for other prescription pain relievers, including older, commonly used medicines like ibuprofen and naproxen.

The label recommends that Celebrex be prescribed at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.