FDA orders halt to production and marketing of unapproved single-ingredient oral colchicine

October 19, 2010

FDA has requested that all companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever, stop manufacturing this drug.

FDA has requested that all companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF), stop the manufacturing of this drug.

Manufacturing of single-ingredient oral colchicine must stop within 45 days and shipping of this unapproved product in interstate commerce must stop within 90 days. A small amount of colchicine is expected to be available after these dates until supplies are exhausted.

The medical community has used many single-ingredient oral colchicine products for decades. These and a variety of other medications have not received the mandatory modern-day FDA-approval required of all prescription drugs.

This action is part of FDA’s broader initiative against marketed unapproved drugs, announced in a June 2006 Compliance Policy Guide.

“The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets,” said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research. “Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients.”

Colcrys (Mutual Pharmaceutical/URL Pharma) is the only FDA-approved single-ingredient oral colchicine product available on the US market. Mutual Pharmaceutical/URL Pharma has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure that all patients will be able to continue affordable access to colchicine. The company also has informed FDA that it will maintain the programs at a minimum until there is FDA-approved generic competition for Colcrys.

The CAP helps eligible patients reduce their Colcrys prescription co-pay to no more than $25 per prescription. Specific information on these programs can be found at www.colcrys.com, www.needymeds.org, or by calling 1-888-811-8423.