The FDA has approved Colcrys (colchicine tablets, from AR Scientific), a single-ingredient oral colchicine product, for the treatment of familial Mediterranean fever (FMF) in patients ≥4 years of age and for acute gout flares. During the application review, the FDA identified safety concerns including drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine that may lead to potentially fatal colchicine toxicity. Data reviewed by the FDA also demonstrated that in the treatment of acute gout flares, substantially lower doses of colchicine are as effective and associated with fewer adverse effects compared to the higher doses traditionally used. Based on these findings, the FDA has made the following recommendations:
- Do not prescribe concomitant P-glycoprotein (P-gp) or strong CYP3A4 inhibitors in patients with renal or hepatic impairment taking colchicine
- Consider a dose reduction or interruption of colchicine therapy in patients with normal renal or hepatic function if treatment with a P-gp or strong CYP3A4 inhibitor is required
- Prescribe the FDA-approved Colcrys dose for the treatment of acute gout flares
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174596.htm.