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Colchicine News

Newly-Published Colchicine Safety Data Provide First Evidence-Based Dosing Guidance to Avoid Potentially Serious Interactions With Commonly Prescribed Drugs

Posted 11 Aug 2011 by

- Paper Published in August Issue of Arthritis & Rheumatism Highlights Several Previously Unknown Drug-Drug Interactions - Colchicine Dose Reductions Necessary in Presence of Certain CYP3A4 or P-gp Inhibitors - Studies Supported URL Pharma Clinical Research Program that Led to FDA Approval of Colcrys® PHILADELPHIA, Aug. 11, 2011 /PRNewswire/ – Newly-published results from a series of colchicine safety studies provide physicians with the first evidence-based dosing guidance for colchicine when co-administered with certain commonly prescribed drugs, helping doctors and patients avoid serious and potentially life-threatening drug-drug interactions. The study results, published in a paper titled "Evidence Basis of a Novel Colchicine Dose Reduction Algorithm to Predict and Prevent Colchicine Toxicity in the Presence of P-gp/CYP450 3A4 Inhibitors," appear in the August issue of Arthritis ... Read more

Related support groups: Colchicine, Colcrys, Proben-C, Probenecid and Colchicine, Colchicine/Probenecid

FDA Orders Halt to Marketing of Unapproved Single-ingredient Oral Colchicine

Posted 1 Oct 2010 by

Drug commonly used to prevent gout, treat gout flares, and treat Familial Mediterranean Fever (FMF) ROCKVILLE, Md., Sept. 30, 2010--The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF). The companies are expected to stop manufacturing single-ingredient oral colchicine within 45 days and must stop shipping this unapproved product in interstate commerce within 90 days. A small amount of unapproved colchicine is expected to be available after these dates until supplies are exhausted.   Many single ingredient oral colchicine products have been used by the medical community for decades. These and a variety of other medications have ... Read more

Related support groups: Colchicine, Colcrys

FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares

Posted 2 Dec 2009 by

New Colchicine Formulation Significantly Reduces Side Effects, Maintains Full Efficacy; Now Indicated for Both Prophylaxis and Treatment of Gout Flares PHILADELPHIA, Oct. 19 /PRNewswire/ – URL Pharma, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Colcrys (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on July 30, 2009 for the treatment of acute gout flares when taken at the first sign of a flare. Colcrys is an oral, branded form of colchicine that has been formulated for optimal efficacy and tolerability. It is the only single-ingredient colchicine to be approved by the FDA for the prophylaxis and treatment of gout flares. Colcrys provides a formulation with the efficacy of colchicine while avoiding most of the toxicity of the unapproved products historically on the market. Colcrys is also ... Read more

Related support groups: Gout, Gout - Acute, Colchicine, Gout - Prophylaxis

FDA Medwatch Alert: Injectable Colchicine (including drugs containing colchicine)

Posted 6 Feb 2008 by

[Posted 02/06/2008] FDA announced its intention to take enforcement 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. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure. This action does not affect colchicine products that are dispensed in tablet form.Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After these dates, all ... Read more

Related support groups: Colchicine

FDA Medwatch Alert: Colchicine Compounded Injectable Products (Posted 05/02/2007)

Posted 2 May 2007 by

[Posted 05/02/2007] ApothéCure and FDA notified all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine 0.5mg/ml, 4ml vials, lot number 20070122@26. The company issued an immediate drug recall for all strengths, sizes and lots of compounded Injectable Colchicine sold within the last year. Customers are asked to examine their stock for ApothéCure compounded Colchicine on hand and to discontinue use immediately and prepare the product for return to the company.[April 30, 2007 - Recall Notice - ApothéCure] Read more

Related support groups: Colchicine, Probenecid and Colchicine

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Related Condition Support Groups

Gout - Acute, Behcet's Disease, Gout - Prophylaxis, Pseudogout - Prophylaxis, Aphthous Stomatitis - Recurrent, Amyloidosis, Familial Mediterranean Fever, Sweet's Syndrome, Biliary Cirrhosis, Constipation - Chronic, Fibromatosis, Linear IgA Disease, Sarcoidosis

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Colcrys, Mitigare

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