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Data Presented at ACR Meeting Demonstrate Safety of Colcrys® (Colchicine, USP) for Treatment of Gout Flares in Patients with Multiple Co-Morbid Conditions
Date:11/8/2010

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Important Safety Information

COLCRYS (colchicine, USP) tablets are indicated for the prophylaxis and 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.

For full Prescribing Information, please visit: http://www.colcrys.com/assets/pdf/COLCRYS_Full_Prescribing_Information.pdf

About URL Pharma

URL Pharma, Inc., headquartered in Philadelphia, PA, is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. After a long history of generic pharmaceutical research, development, and manufacturing, the Company has successfully transitioned to a technology-driven, specialty pharmaceutical business. The Company seeks to develop and commercialize scientifically and medically i
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