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FDA Panel Rejects Gout Drug on Safety Concerns Wed Jun 22, 2011 7:15 am
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FDA Panel Rejects Gout Drug on Safety Concerns


June 21, 2011 -- Safety concerns led an FDA advisory to oppose approval of new drug for gout on Tuesday, despite widespread enthusiasm for the medication's effectiveness against the painful disorder.

The recommendation is likely to push the FDA to hold off on approving the drug, known by the brand name Ilaris, until manufacturers can prove it's safe for long-term use.

The FDA is not required to accept the decision of its advisory panel, but it often does.

Ilaris is an anti-inflammatory drug that studies show can relieve painful gout attacks in patients with gouty arthritis. It's delivered by injection whenever patients have gout flare-ups, which sometimes occur every two to three months or so.

Manufacturers wanted to market the drug, known generically as canakinumab, for gouty arthritis patients who don't get gout relief from other available medications. Novartis, which makes the drug, estimated that about 300,000 U.S. patients would qualify.

Gout occurs when uric acid builds up in the blood, crystallizes, and forms deposits in the joints. It can be extremely painful, and surrounding inflammation can damage adjacent tissue.

http://arthritis.webmd.com/news/20110621/fda-panel-rejects-gout-drug-on-safety-concerns?src=RSS_PUBLIC
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FDA Panel Rejects Gout Drug on Safety Concerns Wed Jun 22, 2011 7:15 am
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