Ankylosing spondylitis, which affects over 400,000 Americans, becomes the sixth approved indication for Celebrex in the US. 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.
Celebrex, a selective COX-2 inhibitor, is also a treatment option 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.
The FDA’s final labeling decision for Celebrex includes a boxed warning of potential cardiovascular and gastrointestinal risks that will be consistent with warnings for other prescription pain relievers, including older, commonly used medicines like ibuprofen and naproxen.
This addition follows a February 2005 meeting of an FDA advisory panel, which conducted a scientific review of selective and non-selective pain relievers. The panel recommended that stronger warnings be added to all selective COX-2 pain medicines as well as to the older, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen.
In addition, the panel recommended avoiding usage of all NSAIDs and Cox-2 selective medicines to treat the acute pain associated with heart by-pass surgery.
Furthermore, the label recommends that Celebrex be prescribed at the lowest effective dose for the shortest duration consistent with individual patient treatment goals. The recommended dose for Celebrex is 200mg daily for osteoarthritis and 200mg to 400mg daily for adult rheumatoid arthritis.