Why was colchicine taken off the market?

Answer 1

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 has been approved by FDA for only for treatment of acute gout flares. Colchicine is also used as a prophylactic to prevent gout flares for daily use. Colcrys has not been approved for that use. Yet Colcrys cost is several dollars per tablet with the monopoly given it by the FDA. While that may be OK to treat gout flares, it becomes extremely expensive for daily preventive use. Generic colchicine should remain available for prophylactic use until a colchicine based drug is approved by the FDA for that use.