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U.S. Department of Health and Human Services

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Single-Ingredient Oral Colchicine Video


Title:
Single-Ingredient Oral Colchicine
(May 14, 2010)
Watch Video:
Windows Media Player
(wmv, 08:20:00) 
QuickTime (.mov, 008:20:00)
Transcript

 

 

In 2006, CDER’s Office of Compliance launched the FDA Unapproved Drugs Initiative to remove unapproved drugs from the market, including a final guidance entitled "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)," outlining its enforcement policies aimed at efficiently and rationally bringing all such drugs into the approval process. The Agency has serious concerns that drugs marketed illegally without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling, thereby posing a significant public health concern. The FDA drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of a finished drug product, and ensuring that health care professionals and patients have the information necessary to understand a drug product's risks and its safe and effective use.

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.

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