FDA targets colchicine as latest unapproved drug pulled from shelves

February 8, 2008

Injectable colchicine is removed from the market by FDA

In the seventh enforcement action taken by the FDA so far against unapproved drugs since it published its injectable colchicine. The FDA said there have been 50 adverse event reports related to use of the drug, including 23 deaths. Typically used to treat gout, the drug has a narrow therapeutic margin, with potential fatal effects, including low blood cell counts, cardiac events, and organ failure. Manufacturers will have 30 days to cease production and 180 days to stop shipping the drug. According to the FDA, there are currently no colchicine products on the market that have undergone agency review and approval, including oral versions of the drug. The latest action will not affect colchicine oral tablets however, due to their wider margin of safety, but could be subject to FDA enforcement at any time, the agency said. The crackdown on unapproved drugs began in June 2006 when the FDA published a Compliance Policy Guide in an effort to ensure that all products marketed in the United States have undergone the approval process and meet various safety, efficacy, and manufacturing standards.

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