FDA acts against unapproved colchicine

Feb 06, 2008

The U.S. Food and Drug Administration said it will take action against companies marketing unapproved injectable colchicine, a drug used to treat gout.

Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously, the FDA said, noting there's only a narrow margin between an effective dose of the drug and a toxic, perhaps even fatal, dose.

Officials said they had received 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths.

"Today's action supports our ongoing efforts to end the marketing of unapproved drugs with serious health risks," said Dr. Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs. "It is a priority that these products be removed from the market."

The FDA warned individuals and companies making the products to cease their activities within 30 days and stop shipping the product within 180 days or face regulatory action. Thereafter, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate.

The FDA said its action announced Thursday does not affect colchicine products that are dispensed in tablet form and are frequently used to prevent gout attacks.

Copyright 2008 by United Press International

Explore further: Britain to offer all infants meningitis B vaccine

Related Stories

Dairy farms asked to consider breeding no-horn cows

2 hours ago

Food manufacturers and restaurants are taking the dairy industry by the horns on an animal welfare issue that's long bothered activists but is little known to consumers: the painful removal of budding horn ...

DARPA seeks new positioning, navigation, timing solutions

8 hours ago

The Defense Advanced Research Projects Agency (DARPA), writing about GPS, said: "The military relies heavily on the Global Positioning System (GPS) for positioning, navigation, and timing (PNT), but GPS access is easily blocked by methods such as jamming. In addition, many environments in which our mil ...

Recommended for you

US aims to cut antibiotic use

Mar 27, 2015

US President Barack Obama on Friday rolled out plans to cut inappropriate antibiotic use by half, in an effort to tackle drug resistance.

Questions over value of new antibiotics to tackle resistance

Mar 26, 2015

In the first installment of a new series, Peter Doshi, Assistant Professor at the University of Maryland School of Pharmacy and Associate Editor at The BMJ, asks why authorities are approving drugs with little evidence they d ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.