Colcrys Gets FDA Approval

The US Food and Drug Administration (FDA) has approved Colcrys to treat acute flairs in patients with gout (a recurrent and painful form of arthritis) and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder.

The medication’s active ingredient is colchicine, a compound derived from the dried seeds of a plant known as the autumn crocus or meadow saffron (Colchicum autumnale).

Colchicine has been used by healthcare practitioners for many years to treat gout but had not been approved by the FDA. The FDA has an initiative underway to bring unapproved products like colchicine under its regulatory framework. FDA is alerting healthcare professionals to this new dosing regimen and also warning about the potential for severe drug interactions when patients take colchicine.

FMF is a hereditary periodic fever syndromes and is characterized by recurrent episodes of fever, arthritis and painful inflammation of the lining layers of the lungs and abdomen. Physicians have prescribed colchicine for FMF for many years based on studies showing that it reduced the frequency of attacks, but use of colchicine for FMF had never been approved.