FDA OKs kids' use of Pfizer's Celebrex

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FDA OKs kids' use of Pfizer's Celebrex

Regulators says drugmaker can market the drug as treatment for kids who

suffer from rheumatoid arthritis.

December 15 2006: 7:44 PM EST

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LOS ANGELES (Reuters) -- Pfizer Inc. won U.S. approval to promote its

Celebrex pain reliever for treating children age two and older who have

rheumatoid arthritis, the Food and Drug Administration said Friday.

Pfizer already sells Celebrex for treating arthritis and other conditions in

adults.

The FDA decision follows a Nov. 29 advisory panel meeting that recommended

approval in children despite uncertainty about the risks of long-term use.

" 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. " Dr. Galson, director of FDA's Center for

Drug Evaluation and Research, said in a statement.

Celebrex is the only medicine still on the U.S. market from the class called

COX-2 inhibitors, which were linked to an elevated risk of heart attacks and

strokes in adults.

The drug's third-quarter 2006 sales jumped 20 percent from a year earlier to

$537 million, according to Pfizer.

The COX-2 inhibitors faced heightened scrutiny after Merck & Co. Inc.

(Charts) pulled Vioxx in 2004, citing a study that found prolonged use

doubled heart attack and stroke risk. Pfizer withdrew another COX-2

inhibitor, Bextra, in 2005.

Celebrex, or celecoxib, stayed on the market with a new warning that it may

raise the chances of serious and possibly fatal heart problems, as may other

non-steroidal anti-inflammatory drugs (NSAIDs) used to fight pain.

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 their joints.

The severity of the condition varies, but there can be disabling joint

swelling and pain, decreased range of motion and abnormal growth in some

cases.

In the Pfizer study, children ages 2 to 16 years took either Celebrex or the

NSAID naproxen for 12 weeks. The percentages of children who benefited were

similar in both groups as were side effects, the company said.

The FDA said Pfizer has agreed to conduct two postmarketing 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 kidney toxicity, high blood pressure, and cardiovascular events.

Pfizer already sells Celebrex for treating arthritis and other conditions in

adults.

Pfizer shares finished slightly higher in Friday trade on the New York Stock

Exchange.