Colchicine gets FDA Stamp of Approval

The US Food and Drug Administration (FDA) has approved Colcrys (colchicine) for the treatment of patients with gout and familial Mediterranean fever (FMF).

The medication, derived from the dried seeds of a plant known as the autumn crocus or meadow saffron, has been used by medical practitioners for many years without FDA approval.

This stamp of approval is part of an FDA initiative to bring unapproved, marketed products like colchicine under a regulatory framework.

Colchicine has traditionally been prescribed hourly for acute gout flares until the flare subsided or treatment had to be stopped because the patient began experiencing gastrointestinal problems.

An FDA dosing study demonstrated that one dose initially and a single additional dose after one hour was just as effective as continued hourly dosing, but much less toxic.

As a result, the drug is being approved for acute gout flares with the lower recommended dosing regimen.

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. With this approval, Colcrys becomes the first drug approved to treat FMF.

Colcrys is manufactured by Mutual Pharmaceutical Company in Philadelphia, US.