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Newly-Published Colchicine Safety Data Provide First Evidence-Based Dosing Guidance to Avoid Potentially Serious Interactions With Commonly Prescribed Drugs
Date:8/11/2011

be reduced between one-third and two-thirds for acute flares, and by 50 to 75 percent for flare prophylaxis, when used as concomitant therapy with six of the seven drugs studied. No colchicine dose adjustments were necessary when used with azithromycin.

In the case of ritonavir, the discovery of serious interactions with colchicine prompted the FDA on May 5, 2010 to require that the new dosing recommendations be included in the prescribing information of all protease inhibitors.

"Despite the fact that colchicine has been used for decades in the prevention and treatment of gout flares and for FMF, the pharmacokinetics and metabolism of colchicine have not been extensively studied, until now," said Robert A. Terkeltaub, M.D., Interim Division Chief and Professor of Medicine at the University of California San Diego and the VA Medical Center, and the paper's lead author. "The results of these studies form the foundation of evidence-based dosing guidance for colchicine in the presence of CYP3A4 or P-gp inhibitors that help achieve optimal therapeutic benefit while avoiding dangerous and unnecessary safety risks."

Safety issues resulting from the concurrent use of colchicine with CYP3A4 or P-gp inhibitors have been documented in the past. At least 60 deaths have been linked to colchicine in patients who were also taking clarithromycin, but there have been no published studies characterizing these interactions, nor any suggestions or recommendations to modify colchicine dosing, according to the authors.

"The need to understand, and avoid, colchicine drug-drug interactions is greater than ever, especially in people with gout," said Matthew W. Davis, M.D., R.Ph., Chief Medical Officer, URL Pharma and a co-author of the paper. "Many gout patients struggle with obesity and have multiple co-morbid conditions, including hypertension, diabetes, metabolic syndrome and renal insufficiency, which may require patients to be on multiple medications. The
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SOURCE URL Pharma, Inc.
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