August 2005 (Newstream) -- The U.S. Food and Drug Administration (FDA) has granted approval for a new indication for CELEBREX® for the relief of the signs and symptoms of ankylosing spondylitis (AS), a form of arthritis that primarily affects the spine. It causes inflammation of the spine and in severe cases, can cause the spine to fuse together. (1a) This fused spine is also known as "bamboo spine." (2a)

WHO IS IMPACTED:
AS affects over 400,000 Americans.(3,4) Unlike some forms of arthritis, which usually affect older people, the onset of this disease is typically in young adults.1b The pain and inflammation associated with advanced ankylosing spondylitis can affect people’s ability to perform even simple everyday tasks, such as sitting, walking and driving.(2b)

TREATMENT WITH CELEBREX:
The effectiveness of CELEBREX for the relief of the signs and symptoms associated with AS was established during a 12-week clinical trial of 611 patients, who were randomized to receive either placebo, 200 mg CELEBREX once a day, 400 mg CELEBREX once a day, or 500 mg naproxen twice a day. Patients were asked to rate their pain intensity, disease activity and physical function.(5a)

Patients taking CELEBREX reported a three-fold improvement in pain intensity while an even greater improvement was observed in disease activity and physical function compared to placebo.(5b)

The type of adverse events reported in the ankylosing spondylitis studies were similar to those reported in arthritis trials. In this trial, there were no serious gastrointestinal (GI) adverse events reported in patients taking CELEBREX or placebo.(5c)

The recommended dose of CELEBREX for the management of the signs and symptoms of ankylosing spondylitis is 200 mg daily single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

IMPORTANT PRODUCT INFORMATION

The following information is contained in a black box warning.

CELEBREX may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with duration of use. 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 (CABG) 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.

CELEBREX is contraindicated in patients with known hypersensitivity to celecoxib; in patients who have demonstrated allergic-type reactions to sulfonamides; and in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or NSAIDs.

CELEBREX can be used with low-dose aspirin. However, there is no consistent evidence that concurrent use of aspirin mitigates the potential increased risk of serious CV thrombotic events associated with NSAID use. Concomitant administration of aspirin with Celebrex increases the rate of GI ulceration or other complications, compared to use of Celebrex alone.

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 such as exfoliative dermatitis, Stevens Johnson syndrome (SJS), and toxic epidermal necrolysis (TENS), which can be fatal. These serious events can occur without warning and in patients without prior known sulfa allergy. Patients requiring NSAID therapy should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

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.

Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

For complete prescribing information, please see www.celebrex.com.

• Spondylitis Association of America. About Ankylosing Spondylitis. Available at: www.spondylitis.org/about/as.aspx. Accessed July 12, 2005.

• Kahn MA. Ankylosing Spondylitis: The Facts. New York, Oxford University Press; 2002.

• Data on file. Pfizer Inc, New York, NY.

Produced for Pfizer

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