On Wednesday, November 29, the Food and Drug Administration’s independent Arthritis Advisory Committee met to discuss the safety and efficacy of celecoxib, a nonsteriodal anti-inflammatory drug (COX-2 inhibitor). Celecoxib is marketed as Celebrex stuby Pfizer, Inc. The FDA approved the drug for use in adults with osteoarthritis and rheumatoid arthritis in 1998. Now, Pfizer has submitted the current application being discussed by the advisory committee for the indication of the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older.
Today, arthritis-related websites are reporting that the FDA Arthritis Advisory Committee voted 15-1 to recommend FDA approval of Celebrex as a treatment option for JRA, based on data showing Celebrex was effective for the condition. The committee first voted 8-7 with one abstention that data did not conclude Celebrex was safe for children with arthritis. Despite long-term safety concerns, the committee ultimately recommended approval because they felt benefits of the drug outweigh the cardiovascular risks.
Before the Advisory Committee meeting yesterday, there was speculation in the industry and reports by the Associated Press that Pfizer may not have been able to convince the FDA that Celebrex should receive expanded approval to treat children with JRA. The AP mentioned FDA review documents that question whether the drug works for the pediatric disease. (At the time of writing this I was unable to locate those FDA documents on either the FDA website or elsewhere on the internet.) The advisory committee gives advice to the FDA and will make a recommendation as to whether Celebrex should be approved for children. The FDA usually follows the advice of its advisory committee, but is not required to do so.
Celebrex is the only member of the cox-2 inhibitor class of drugs (which also includes drugs such as Vioxx and Bextra) that was not withdrawn from the market over research showing that they elevate the risk of heart attacks and strokes in adults. Prior research studying Celebrex as a possible way to prevent cancer in adults showed that taking 400 milligrams of the drug twice a day tripled the risk of having a heart attack, stroke, or heart failure, and of dying from other cardiovascular causes. In 2005, Pfizer released the results of an Alzheimer's prevention trial Pfizer finished in 2000, which also showed increased cardiovascular risk with Celebrex. And according to another study published separately this year, patients recovering from heart attacks who then took Celebrex had nearly double the risk of dying and a 1.5 -fold increased risk of having another attack. In 2004, the NIH ended its studies of Celebrex as a treatment for cancer because of the cardiovascular side effects of the drug. The FDA subsequently requested that Pfizer stop its consumer-directed ads for Celebrex, which the company did in December 2004. However, Pfizer resumed running print ads again for it last February.
In its application, Pfizer acknowledged the risk, but also provided results of a study showing that Celebrex, works just as well as naproxen in treating young rheumatoid arthritis patients and is gentler on the stomach than naproxen. However, the Associated Press article printed in the Boston Globe online quotes the FDA as being concerned that limitations to the dy's design "raise questions about whether it provides adequate evidence of efficacy of celecoxib" in the children's disease. The agency reviewers are also concerned with the cardiovascular risks of long-term use of the drug in children, and suggest that more study is needed.
The AP article states that children account for less than half of 1 percent of the prescriptions dispensed for Celebrex. While some physicians do prescribe Celebrex for JRA, “surveys suggest orthopedic surgeons are the most common prescribers of the drug for kids, typically to treat sprains and injuries,” the FDA said.
What are your thoughts on the FDA Arthritis Advisory Committee voting to approve Celebrex for use in children? Share your view on the RA Message Boards.
Published On: December 01, 2006