FDA Drug Safety Communication

FDA is highlighting important safety considerations found in the approved prescribing information to assure safe use of Colcrys, which is approved for the treatment of familial Mediterranean fever (FMF), acute gout flares, and prophylaxis of gout flares. FDA recommends:

- Healthcare professionals not use P-glycoprotein (P-gp) or strong CYP3A4 inhibitors in patients with renal or hepatic impairment who are currently taking colchicine.

- Healthcare professionals consider a dose reduction or interruption of colchicine treatment in patients with normal renal and hepatic function if treatment with a P-gp or a strong CYP3A4 inhibitor is required.

- Healthcare professionals prescribe the FDA-approved Colcrys dose for the treatment of acute gout flares: 1.2 mg followed by 0.6 mg in 1 hour (total 1.8 mg).

- Healthcare professionals refer to Colcrys' approved prescribing information for specific dosing recommendations and additional drug interaction information.

- Patients review the Medication Guide for important safety information

This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov