Gout Drug Rejected by FDA Panel

by Kathy Jones on  June 23, 2011 at 9:00 PM Drug News   - G J E 4
A US Food and Drug Administration panel almost unanimously voted down the recommendation for approving a gout drug developed by Novartis over fears of safety and side effects.
 Gout Drug Rejected by FDA Panel
Gout Drug Rejected by FDA Panel

The drug was voted down 11-1 by the FDA panel for its usage in preventing gout attacks and also rejected it for using it to delay or reduce the frequency of future attacks.

While the drug, known as Ilaris, proved itself to be effective among gout patients, the panel was concerned about the high incidence of infections and side effects.

Commenting on the recommendation, panel member Dr David Felson said, "I found the safety issues to be overwhelmingly concerning. We're giving therapies that in some cases may be life-threatening for a disease that is not. Forty-three patients with recurrent treatment is too small a number for us to be confident that this would be safe for people over time."

Source: Medindia

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