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BY OUR PHARMA CORRESPONDENT
4 August, 2005: 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. 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.
The recommended dose for Celebrex is 200 mg daily for osteoarthritis and 200 mg to 400 mg daily for adult rheumatoid arthritis. For the management of the signs and symptoms of ankylosing spondylitis, the recommended dose of Celebrex is 200 mg daily in single or divided twice per day doses. If no effect is seen after six weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after six weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options. The approved dose for the prevention of intestinal polyps associated with familial adenomatous polyposis is 800 mg daily.
In the release, the company also alerts the patients on the following:
Celebrex may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Celebrex is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
NSAIDs, including Celebrex, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
As with all NSAIDS, Celebrex can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. NSAIDs should be used with caution in patients with hypertension.
Celebrex is a sulfonamide and can cause serious skin adverse events, which can be fatal. These serious events can occur without warning and in patients without prior known sulfa allergy.
The most common side effects in arthritis trials were dyspepsia, diarrhea, and abdominal pain, and were generally mild to moderate. The types of adverse events reported in the ankylosing spondylitis studies were similar to those reported in the arthritis studies. BY OUR PHARMA CORRESPONDENT
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