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Mon 1 Jan 2007 02:01 PM

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JRA indication approved for Celebrex

Pfizer's blockbuster Celebrex (celecoxib) has won FDA approval for pain relief in juvenile rheumatoid arthritis, despite uncertainty about the drug's safety profile in long-term use.

Pfizer's blockbuster Celebrex (celecoxib) has won FDA approval for pain relief in juvenile rheumatoid arthritis, despite uncertainty about the drug's safety profile in long-term use.

The decision, less than a month after the US Food and Drug Administration committee unanimously recommended approval, now allows Pfizer to market the drug specifically for juvenile rheumatoid arthritis.

However, approval was accompanied by a caveat. Pfizer must conduct two Phase IV post-marketing studies; a short-term controlled trial to evaluate high blood pressure, and a several-year registry study to further evaluate long-term safety issues, including renal toxicity, high blood pressure, and cardiovascular events.

"JRA is often a devastating disease," said Dr Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "While there are other medicines approved for the treatment of this disorder, for some children they may have limited effectiveness or cause intolerable side effects. Celebrex will be a needed additional treatment option for children."

The FDA also noted that Celebrex has not been studied in patients under the age of two years, in patients who weigh less than 22 pounds, or in patients showing signs of having systemic-onset JRA. Consequently, the agent should be used only with caution in patients with systemic-onset JRA due to the risk for serious adverse reactions, including abnormal clotting tests, which can be associated with disseminated intravascular coagulation.

"Safety and efficacy were not studied beyond six months, and experience with adults suggests the possibility of longer term cardiovascular problems," said the FDA.

The best-selling prescription drug is the only COX-2 inhibitor still available on the US market, after the class was linked to an elevated risk of cardiovascular events in adults.

After Vioxx and Bextra were pulled from the market in 2004 and 2005 respectively, Celebrex stayed on the market with a new label warning that it may raise the chances of serious cardiovascular events.

Pfizer won an extra six months of exclusive marketing time for Celebrex in exchange for the study of juvenile rheumatoid arthritis, a disease that afflicts about 30,000 to 60,000 U.S. children when their immune system attacks the joints.

The FDA approval cited the 24-week study of Celebrex, which treated 242 patients between the ages of two and 17 years and demonstrated its effectiveness in treating JRA. Among study participants, the most commonly reported side effects were cough, cold, upper respiratory tract infection, abdominal pain, headache, fever, nausea, diarrhoea, and vomiting.

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