FDA launches educational videos for pharmacists

July 15, 2010

In the first of its "FDA Drug Info Rounds," a new series of educational videos for pharmacists, FDA is tackling unapproved dispensing of colchicine.

In the first of its "FDA Drug Info Rounds," a new series of educational videos for pharmacists, FDA is tackling unapproved dispensing of colchicine.

The Drug Info Rounds series seeks to educate pharmacists about FDA-approved drugs so that they can better inform consumers about certain medications. The agency chose to focus first on Colcrys and colchicines, primarily used to treat chronic gout and familial Mediterranean fever (FMF), in response to numerous questions it has received from consumers.

In 2009, FDA approved the first single-ingredient oral colchicine, Colcrys, for acute gout flares and FMF. The approval includes a new drug-interaction warning, updated dosing recommendations, and a medication guide. However, unapproved colchicines have been on the market since the 1930s, and their lack of FDA prescribing and safety information is causing confusion among patients.

FDA approval means that the medications have gone through clinical trials demonstrating their safety and effectiveness. Unapproved colchicines may still be on the market, the FDA video warns, because colchicine predates existing FDA laws and regulations.

The unapproved colchicines are not generic versions of Colcrys, according to the video. "Generic drugs are those evaluated and approved by FDA to demonstrate bioequivalence to a brand-name-referenced product. These unapproved products have not been evaluated or approved by the FDA," the video stated.

Of the 21 firms that manufacture and distribute oral colchicine, only Mutual Pharmaceuticals, the maker of Colcrys, has sought FDA approval.