Frequently Asked Questions for Pharmacists on oral colchicine products:
Q: What action has the FDA taken regarding single-ingredient oral colchicine?
A: On September 30, 2010, FDA ordered companies to stop marketing unapproved single-ingredient oral colchicine products. Furthermore, companies were directed to stop manufacturing these products within 45 days and to stop shipping within 90 days. Once those time frames lapsed, only single-ingredient oral colchicine products having FDA approval could be manufactured or shipped.
Q: Why did FDA take action against single-ingredient oral colchicine products?
A: Under policies announced in 2006, FDA will remove drugs with potential risks and that present direct challenges to the new drug approval system. Unapproved drugs have not been reviewed for safety and efficacy by FDA. In addition, the drug approval process allows the FDA to evaluate components of the formulation, manufacturing, and labeling process. Single-ingredient oral colchicine products (with the exception of Colcrys, as discussed below) are not approved by FDA.
Q: What product(s) will be available for the daily prophylaxis of gout flares, the treatment of acute gout flares, and the treatment of Familial Mediterranean Fever (FMF)?
A: The FDA has approved Colcrys, which is manufactured by Mutual Pharmaceuticals/ URL Pharmaceuticals for these indications. Colcrys is currently the only FDA approved single-ingredient oral colchicine product available. Mutual obtained approval in 2009 and has informed FDA of its ability to meet the market demands for this product. FDA informed manufacturers of other colchicine products that they would either have to submit marketing applications or take their products off the market.
Q: Will there be generic or combination forms of colchicine available to consumers?
A: There are no FDA approved generic versions of single-ingredient oral colchicine available on the market.
There are FDA-approved versions of colchicine available in combination products. These agents are not related to the announcement regarding single-ingredient colchicine.
Q: Can I dispense a single-ingredient oral colchicine product other than Colcrys?
A: As discussed above, all single-ingredient oral colchicine products other than Colcrys have been ordered off the market, and any still circulating are unapproved drug products. Some pharmacists have pointed out that the FDA’s press release concerning this matter also states that “a small amount of unapproved colchicine is expected to be available after these dates until supplies are exhausted.” That sentence undoubtedly states a truism. In making a professional judgment about dispensing any of this residual unapproved colchicine still floating around, pharmacists should bear in mind that the product is unapproved (and therefore adulterated and misbranded under federal law) and has been ordered off the market for health and safety reasons. Accordingly, pharmacists should be mindful of potential harm to patients and the attendant consequences.
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