Pfizer Inc. might have to conduct further studies on its pain reliever Celebrex before it is approved to treat rheumatoid arthritis in children, the Food and Drug Administration staff said.
Celebrex, which is approved to treat arthritis in adults, has faced safety concerns over an increased risk of heart attacks and strokes for those who take it.
The drug belongs to the same class of painkillers as Merck & Co.'s Vioxx. Merck pulled the drug from the market in 2004 after its studies showed Vioxx doubled the risk of heart attacks and strokes. Pfizer continued to sell Celebrex after it strengthened label warnings about its risks.
This year the New York drug maker requested FDA approval for Celebrex to treat juvenile rheumatoid arthritis in patients ages two years and older. The FDA is holding a meeting today with an outside panel of experts, who will be asked to weigh the risks and benefits of the drug for the treatment in children.
According to documents posted on the FDA's Web site, about 30,000 to 60,000 children in the U.S. suffer from the condition. In severe, uncontrolled cases, rheumatoid arthritis can cause permanent disability.
While there are other drugs approved to treat the condition in children, "for some patients these approved products may provide limited efficacy or intolerable side effects," the FDA said. Those drugs include aspirin, ibuprofen and naproxen to treat the pain.
On the safety of the drug, the staff said "a key consideration" in assessing the issue "is the evidence of increased risk of cardiovascular adverse events in adults." Heart risks to children who take Celebrex long term are unknown.
In a trial conducted with children, the most common adverse events of Celebrex were certain infections and infestations, and nervous-system disorders. Compared with naproxen, common adverse events with Celebrex were similar in type and frequency, the staff said.
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