FDA Drug Info Rounds, May 2010: Single-ingredient Oral Colchicine

Although unapproved colchicine has been used for many years, FDA approved the first single-ingredient oral colchicine product, Colcrys, in July 2009 for the treatment of familial Mediterranean fever (FMF) and acute gout flares; in October 2009 Colcrys was approved for prophylaxis of gout flares (chronic gout). The approved prescribing information for Colcrys includes a new drug interaction warning, updated dosing recommendations and a medication guide. Pharmacists are reminded to dispense only FDA approved products.

FDA Drug Info Rounds pharmacists discuss the differences between approved and unapproved colchicine products, concerns regarding unapproved single-ingredient oral colchicine, and how patients can offset the increased cost of Colcrys.

For more information, please see our website:
http://www.fda.gov/Drugs/ResourcesFor...
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