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04/30/2009 - News

FDA Recommends New Drug for Gout

By: June Chen, MD

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FDA Recommends New Drug for Gout

June Chen, MD

Last week, a US Food and Drug Administration (FDA) expert panel recommended that the FDA approve febuxostat (or, Uloric) for the treatment of gout.

If approved, Uloric would be the first new gout drug to be FDA-approved in over 40 years. The only drug currently approved by the FDA for the prevention and treatment of gout is allopurinol (marketed as Zyloprim®). Although allopurinol can be very effective, it has potentially fatal side effects that limit the doses that patients can tolerate. As a result, many gout patients do not receive fully effective doses.

Data from clinical trials suggest that Uloric works at least as well as, if not better than, allopurinol for the treatment of gout. Although previous studies suggested that Uloric might increase the risk for heart problems and death, a larger, more recent clinical trial showed no statistically significant differences in the risk of death and heart problems between patients taking Uloric and patients taking allopurinol.

In adults over the age of 80, gout affects 9% of men and 6% of women. If approved, Uloric could potentially be a safe and effective alternative to allopurinol for the pain and limited joint mobility associated with gout.

Source
FDA, 'Briefing Document for the Arthritis Advisory Committee Meeting,' November 24, 2008.

Created on: 12/05/2008
Reviewed on: 04/30/2009

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