GAITHERSBURG, Md. — Pfizer Inc. should get American approval to market its Celebrex arthritis-pain pill for use in children because the benefits outweigh the risks, a Food and Drug Administration advisory panel said.

The committee of outside doctors and other specialists voted 15–1 that the benefit of the drug in children outweighs a lack of evidence on its longerterm safety. Panel members, meeting yesterday in Gaithersburg, Md., said studies are needed to track the risks of long-term use of Celebrex.

“There is a need for more drugs on the market for children” with arthritis, the acting chairwoman of the FDA panel and a professor of medicine at Johns Hopkins University School of Medicine in Baltimore, Joan Bathon, said in an interview. “The strong message is that there needs to be a much more robust safety assessment.”

Testing Celebrex in children gave Pfizer, the world’s biggest drugmaker, six more months of patent protection, an incentive the FDA grants to companies to develop pediatric treatments. The safety of the drug, approved for inflammation in adults with rheumatoid arthritis, was questioned by the FDA in 2004 after the withdrawal of Merck & Co.’s similar Vioxx.

Shares of Pfizer rose 2 cents to $27.07 at 4:01 p.m. in New York Stock Exchange composite trading. They had gained 16% this year before yesterday.

The panel had voted 8–7, with one abstention, that testing hadn’t clearly established Celebrex’s safety in children. In a separate vote, they determined unanimously that the drug is effective. The advisers recommended a registry of patients to track longer-term effects, while not specifically voting on that as a requirement.

“If we decide we need to say we can’t prove something is safe because we can’t see 20 years into the future, we’re going to have no drugs for our kids,” a panel member and chief of pediatric rheumatology at the Hospital for Special Surgery in New York, Thomas Lehman, said.

The financial effect for Pfizer of getting clearance to market Celebrex for children would be limited by the small number of potential patients. Between 30,000 and 60,000 children in America have rheumatoid arthritis, and the disease can last into adulthood, according to the FDA.

By comparison, about 2.1 million adults have the disorder, or 1% of the American population, according to the nonprofit Arthritis Foundation.

The autoimmune disorder occurs when the body attacks its own tissue and cells, causing swelling, heat, redness, and pain, mostly in and around the joints, according to the American College of Rheumatology.

Treatments include nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, and naproxen to treat the pain, and methotrexate to slow the disease’s progression. An injection, Wyeth’s Enbrel, is also approved for use in children when other treatments fail.

Pfizer kept selling Celebrex after the Vioxx recall and strengthened warnings in prescribing information related to higher heart attack and stroke risks.

Doctors already prescribe Celebrex “off label” to as many as one in 10 children with rheumatoid arthritis even without marketing approval, Pfizer’s medical director for Celebrex, Gail Cawkwell, said in a telephone interview on Tuesday.

“We are happy that we might be able to offer another agent to treat patients with a chronic illness,” a vice president in Pfizer’s worldwide medical division, Steven Romano, said in an interview after the panel meeting yesterday.

Long-term safety data for children also is lacking on other drugs in the class, and existing research in adults shows Celebrex poses no additional risk, Romano said. He said that the company is willing to discuss with the FDA doing the kind of long-term study in children that was suggested by the panel.

Long-term cardiovascular risks to children treated with Celebrex “may not be clear based on currently available data, “the FDA said in a staff report on Tuesday. The advisers should “consider the need for further studies of the effectiveness and toxicity associated with Celebrex use” in children, and “define an appropriate path forward for those investigations,” the review said.