Updated Safety Information for Colchicine
FDA has now approved the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares. Previously, oral colchicine was used for many years without FDA approval.
Though the FDA has approved this drug, it points to two new safety issues. First, fatal colchicine toxicity was reported with certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. Drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity.
Second, data revealed that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, the lower dose is associated with significantly fewer adverse events compared to the higher dose.
Thus, the FDA recommends that patient with renal or heptic impairment not simultaneously use P-glycoprotein (P-gp) or strong CYP3A4 inhibitors and colchicine. Additionally, when possible doctors should opt to give their gout patients a lower does of Colchicin.
For more information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174315.htm