Where Is Generic Colchicine?

Darrell Hulisz, PharmD


July 17, 2012


Can you explain the recent confusion surrounding the generic availability of colchicine? Why is there only 1 brand of colchicine product available?

Response from Darrell Hulisz, PharmD
Associate Professor, Case Western Reserve University School of Medicine; Clinical Specialist in Family Medicine, University Hospitals, Case Medical Center, Cleveland, Ohio

Colchicine is currently approved for prophylaxis and treatment of acute gout exacerbations. Colchicine is also approved for the treatment of familial Mediterranean fever.[1] Many single-ingredient oral colchicine products were used by the medical and pharmacy community for years but did not undergo the mandatory, modern-day US Food and Drug Administration (FDA) approval process that is required of all prescription drugs. The FDA reports that unapproved single-ingredient oral colchicine has been associated with serious adverse events, including fatalities.[2,3]

In the fall of 2011, the FDA issued statements declaring that single-ingredient oral colchicine products would be considered new drugs that require approved applications because they are not generally recognized as safe and effective.[2,3] At this time, only 1 pharmaceutical manufacturer has obtained approval to market single-ingredient oral colchicine for the treatment of acute gout flares, prophylaxis of gout flares, and familial Mediterranean fever. Thus, no generic exists for colchicine. Manufacturers who wish to market single-ingredient oral colchicine products must obtain FDA approval prior to marketing.

It is also important to note that colchicine often causes dose-related gastrointestinal adverse effects that occasionally may be severe. Few studies have been conducted to determine the optimal dosing regimen in acute gout attacks. The Acute Gout Flare Receiving Colchicine Evaluation (AGREE) study[4] was conducted to determine the efficacy and safety of high- vs low-dose colchicine in 184 patients with acute gout flare. Patients were randomly assigned to either: (1) low-dose colchicine (1.2 mg orally followed 1 hour later with 0.6 mg), (2) high-dose colchicine (1.2 mg orally followed by 0.6 mg hourly for 6 hours), or (3) placebo.

Outcomes were assessed after 24 hours, with both high- and low-dose colchicine yielding significant clinical improvement vs placebo. There were no significant differences in adverse events between low-dose colchicine and placebo. In the high-dose group, however, severe diarrhea occurred in 19% of patients and vomiting in 17% of patients, significantly more than with low-dose colchicine and placebo. Thus, on the basis of this study, low-dose colchicine is preferred over higher-dose colchicine due to comparable efficacy and better gastrointestinal tolerability.

In conclusion, pharmacists can advise patients that a generic version of oral single-ingredient colchicine is no longer available. It is available only as the brand-name product Colcrys® (URL Pharma; Philadelphia, Pennsylvania).


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