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Use of Pfizer Drug in Children Is Backed 2006-11-30
By Associated Press

Use of Pfizer Drug in Children Is Backed

WASHINGTON, Nov. 29 (AP) — Federal advisers recommended Wednesday that Pfizer be allowed to market the painkiller Celebrex as a treatment for children with a devastating form of arthritis, even though they were split on whether it was safe.

In a 15-1 vote, the advisers said that the benefits of the drug outweighed its risks for juvenile rheumatoid arthritis patients 2 years old and older. They also strongly recommended that its safety be monitored for years.

The Food and Drug Administration must now weigh the panel’s recommendation that it expand approval of Celebrex. The agency is not required to follow the advice of its expert panels, but it usually does.

Earlier, the agency’s arthritis advisory committee agreed unanimously that the drug was an effective treatment for juvenile rheumatoid arthritis, which affects as many as 60,000 children in the United States.

However, in an 8-7 vote, with one abstention, panel members said that available data did not demonstrate that Celebrex was safe in treating the disease, commonly called J.R.A.

Celebrex is the only member of a class of drugs that included Vioxx and Bextra not to have been withdrawn from the market over concerns that they elevated the risk of heart attacks and strokes in adults. Before the meeting, F.D.A. reviewers had questioned the cardiovascular risks of long-term use of the drug in children.

“The feeling was short-term efficacy looked good and short-term safety was not an issue. Long-term safety is totally unknown and needs to be known,” said a panel member, Dr. Joan M. Bathon, a Johns Hopkins University rheumatologist.

The panel said the long-term safety of the drug should be studied, possibly by creating a registry of patients that would allow their health to be tracked.


 
 
 
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