FRIDAY, Oct. 1 (HealthDay News) -- The U.S. Food and Drug Administration has ordered companies manufacturing, distributing, or marketing unapproved single-ingredient oral colchicine to cease doing so.
Colchicine is commonly used to prevent and treat gout and to treat familial Mediterranean fever. Although many single-ingredient oral colchicine products have been used for decades by the medical community, only Colcrys, which includes important safety and drug interaction data with its prescribing information, is approved by the FDA.
Companies are expected to stop manufacturing and shipping colchicine within 45 and 90 days, respectively. Mutual Pharmaceutical/URL Pharma, the manufacturer of Colcrys, has established patient assistance and copay programs to ensure affordable access to colchicine until the FDA approves generic competition for Colcrys.
"The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets," Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, said in a statement. "Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients."