Colcrys Approved for Acute Gout, Mediterranean Fever
FRIDAY July 31, 2009 -- Colcrys has been approved by the U.S. Food and Drug Administration to treat acute gout and familial Mediterranean fever (FMF), two inflammatory disorders. The drug's active ingredient, colchicine, is derived from the dried seeds of the autumn crocus plant.
In a news release, the agency said colchicine has been used as a remedy to treat acute gout flares "for many years," despite that it hadn't been FDA approved. The agency said it was in the midst of a program to bring other similarly unapproved products under its regulatory authority.
A dosing study required for approval led the agency to recommend a lower dosing regimen for Colcrys that had been commonly prescribed, the news release said. This was designed to prevent gastrointestinal problems.
The FDA said it was alerting healthcare professionals of the lower dosing schedule and also warning that the drug had the potential for severe interactions with other medications.
FMF, common in Mediterranean nations but less so in the United States, has symptoms including fever, arthritis, and inflammation of the lining of the lungs and abdomen. Colcrys is now the first drug that's been FDA-approved to treat FMF, the agency said.
The drug is produced by Philadelphia-based Mutual Pharmaceutical Company Inc.
The FDA has more about this medication's approval.
Posted: July 2009