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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

ommonly adult men. It occurs when excess uric acid in the body is deposited as needle-like crystals, or tophi, in the joints or soft tissues, which cause inflammatory arthritis and can lead to gout flares typically lasting three to 10 days.

Gout flares are characterized by intermittent swelling, redness, heat, joint stiffness and pain, which are often excruciating and can be debilitating enough to significantly interfere with work, social activities and daily living. For many people, gout initially affects the joint of the big toe, though it can also affect other joint areas such as the ankles, heels, knees, wrists, fingers and elbows.

About Familial Mediterranean FeverFamilial Mediterranean Fever (FMF) is a rare, inherited inflammatory disorder generally found in people of Mediterranean origin and characterized by recurrent fevers and painful inflammation of the abdomen, lungs and joints. Colchicine has been used to treat FMF since 1972 and is considered the "gold standard" in the treatment of the disease.  Although the mechanism is not yet fully understood, Colcrys appears to be effective in FMF by blocking both inflammation and a condition known as amyloidosis.

Important Safety InformationCOLCRYS® (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, thrombo-cytopenia, and leukopenia have been reported in patients taking colchicine. Rhabdomyolysis has been occasionally observed, especially when colchicine is prescribed in combi
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