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Download Medication Guide Unapproved Colchicine - Unnecessary risks for patients

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Important Safety Information

COLCRYS^® (colchicine, USP) tablets are used to prevent and treat gout flares.

COLCRYS can cause serious side effects in people with kidney or liver problems who are taking medicines that interfere with COLCRYS. COLCRYS can also cause serious muscle problems. You have a higher chance for muscle problems if you are taking certain other medicines with COLCRYS. Certain medicines when taken with COLCRYS can cause the levels of COLCRYS to be too high in your body. Discuss any health problems you have, as well as medicines you are taking (including non-prescription medications and herbal supplements), with your healthcare provider before starting COLCRYS. The most common side effect in clinical trials for the prevention and treatment of gout was diarrhea.

For more information, refer to the patient Medication Guide in the full Prescribing Information. This information is not intended to replace discussions with a healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

You may also report negative side effects to the manufacturer of COLCRYS by calling 1.888.351.3786.

References: 1. U.S. Food and Drug Administration Web site. Orange Book: Approved Drug Products with Therapentic Equivalence Evaluations. www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm. Accessed September 4,2009. 2. COLCRYS [package insert]. Philadelphia, PA: AR Scientific, Inc. A URL Pharma company; 2009. 3. Data on file, URL Pharma Inc. 4. Merck Manual Professional. Gout: Crystal-Induced Arthritides. http://www.merck.com/mmpe/print/sec04/ch035/ch035b.html. Accessed September 1, 2009. 5. Chen LX, Schumacher HR. Gout: an evidence-based review. J Clin Rheumatol. 2008;14(5 suppl):S55-S62. 6. Merck Manual Home Edition. Gout: Gout and Pseudogout. http://www.merck.com/mmhe/print/sec05/ch070/ch070b.html. Accessed September 1, 2009. 7. Kramer HJ, Choi HK, Atkinson K, Stampfer M, Curhan GC. The association between gout and nephrolithiasis in men: The Health Professionals' Follow-Up Study. Kidney Int. 2003;64(3):1022-1026. 8. Weaver AL. Epidemiology of gout. Cleve Clin J Med. 2008;75(suppl 5:)S9-S12. 9. Wall GC, Cooper SA. Gout and hyperuricemia: new guidelines and treatments. J Pharm Pract. 2009;22:104-115. 10. Gout & Uric Acid Education Society Risk Factors and triggers. http://www.gouteducation.org/gout/factors.aspx. Accessed September 1, 2009.