Important Safety Information

COLCRYS^® (colchicine, USP) tablets are indicated for prophylaxis and the treatment of gout flares.

COLCRYS is contraindicated in patients with renal or hepatic impairment who are concurrently prescribed P-gp inhibitors or strong inhibitors of CYP3A4 as life-threatening or fatal toxicity has been reported. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors. The most common adverse events in clinical trials for the prophylaxis and treatment of gout were diarrhea and pharyngolaryngeal pain. Rarely, myelosuppression, thrombocytopenia, and leukopenia have been reported in patients taking colchicine. Rhabdomyolysis has been occasionally observed, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Monitoring is recommended for patients with a history of blood dyscrasias or rhabdomyolysis.

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.

Please see full Prescribing Information.

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. 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. 5. Merck Manual Professional. Gout: Crystal-Induced Arthritides. http://www.merck.com/mmpe/print/sec04/ch035/ch035b.html. Accessed September 1, 2009. 6. Chen LX, Schumacher HR. Gout: an evidence-based review. J Clin Rheumatol. 2008;14(5 suppl):S55-S62. 7. Merck Manual Home Edition. Gout: Gout and Pseudogout. http://www.merck.com/mmhe/print/sec05/ch070/ch070b.html. Accessed September 1, 2009. 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.