FDA Orders Halt to Marketing of Unapproved Oral Colchicine

Fran Lowry


October 01, 2010

October 1, 2010 — The US Food and Drug Administration (FDA) has ordered companies to stop marketing unapproved single-ingredient oral colchicine, a medication commonly used to prevent gout and to treat gout flares and familial Mediterranean fever.

The companies are expected to stop manufacturing single-ingredient oral colchicine within 45 days and must stop shipping the unapproved product in interstate commerce within 90 days. A small amount of the product will be available after these dates until supplies are exhausted, according to a press release issued yesterday by the FDA.

The FDA states that many single-ingredient oral colchicine products have been used by the medical community for decades but that they have not received FDA approval, which is now required of all prescription drugs.

At this time, Colcrys (Mutual Pharmaceutical/URL Pharma) is the only FDA-approved single-ingredient oral colchicine product in the United States.

The manufacturer of Colcrys has established a patient assistance program and a co-pay assistance program to ensure continued affordable access to colchicine and has pledged that it will maintain the programs until an FDA-approved generic version of Colcrys becomes available. Specific information about these programs can be found at https://www.colcrys.com and https://www.needymeds.org or by calling 1-888-811-8423.

The marketing of unapproved injection colchicine products was stopped by the FDA in February 2008.

Deborah M. Autor, director of the FDA's Center for Drug Evaluation and Research, said in a statement: "It is a priority for the FDA to get unapproved medications, such as older versions of single ingredient oral colchicine, either updated to conform to FDA's current approval standards or off the market. The FDA remains committed to ensuring that prescription drugs have the necessary FDA approval. We encourage companies to actively pursue approval or face the type of action announced today."

More information about the order is available on the FDA Web site.