WASHINGTON -- The FDA has warned manufacturers, marketers, and distributors of single-ingredient oral colchicine products to stop distribution of the unapproved drugs.
There is only one such product -- Colcrys -- that's been approved by the FDA. The agency approved Colcrys for treatment of acute gout flares in August of 2009.
Despite the fact that colchicine has been used for some 200 years for treatment of gout and familial Mediterranean fever, the unapproved products ordered off the market on Thursday are not considered generic drugs and have not been evaluated by the FDA, the agency said in a statement.
The FDA statement noted that Colcrys has "important safety data and recommendations on drug interactions and dosing not available with unapproved products."
Colcrys manufacturer Mutual Pharmaceutical/URL Pharma had set up a patient assistance program and copay assistance program to keep the treatment affordable for patients with and without insurance or for those on Medicare, and will keep the programs open at least until the FDA approves a generic form of the drug, the FDA statement said.
The agency ordered the companies stop manufacturing within 45 days and cease shipping within 90, an FDA statement said.
"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," said Deborah M. Autor, of the FDA's Center for Drug Evaluation and Research.
"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," Autor said in the statement announcing the order.