FDA OKs Celebrex for Kids With Arthritis

Arthritis News

1. FDA OKs Celebrex for Kids With Arthritis
(Source: healthday.com)

FRIDAY, Dec. 15 (HealthDay News) -- The U.S. Food and Drug Administration Friday gave the green light to Celebrex for use in kids older than two as a treatment for juvenile rheumatoid arthritis.

The agency's action followed an advisory panel recommendation just over two weeks ago, which found that the benefits of the painkiller for children outweighed the shortage of proof on its safety.

The panel, a committee of doctors and other specialists, voted 15-1 to approve the expanded use. But it also voted 8-7, with one abstention, that available data doesn't demonstrate that Celebrex is safe in treating JRA and that a registry should be established to track these young patients for 10 to 20 years.

As part of the approval process, the FDA said Friday, the drug's manufacturer, Pfizer, has agreed to conduct two Phase 4 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.


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