WASHINGTON — After almost 200 years of common use, colchicine (Colcrys) has won FDA approval for treatment of acute flares of gout and familial Mediterranean fever.
Colchicine, a compound derived from the dried seeds of the meadow saffron, has long been used to treat gout and is part of an FDA-approved combination product. But it had not been approved by the FDA as a standalone drug.
Physicians have prescribed colchicine since 1810 for treating acute gout under an hourly dosing regimen that proved effective against the inflammatory disorder but often ended in gastrointestinal toxicity.
FDA approval was based on a study that found that two doses an hour apart were equally effective at combating the condition with lower risk. As a result, the drug has been approved with the new, lower dosing regimen and a warning about the potential for severe drug interactions.
Colchicine will be the first FDA-approved drug for the treatment of familial Mediterranean fever, an inherited inflammatory disorder that’s rare here but more common in Mediterranean countries.
The approval of colchicine was part of an FDA initiative to bring more unapproved but marketed products under regulation for modern standards of safety, effectiveness, quality, and labeling.
The drug is manufactured by Mutual Pharmaceutical Company in Philadelphia.