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Got gout? FDA to colchicine manufacturers: Get FDA-approved

Got Gout? Or Familiar Mediterranean Fever (FMF)? If so, you may have been prescribed oral colchicine, a medication commonly used to treat those conditions. Gout and FMF patients should be aware that the FDA has ordered companies that make, distribute or market that drug to stop doing so, unless they have FDA-approval.

This may come as something of a surprise to patients, doctors and even pharmacists who assume that all drugs available in the United States are FDA-approved. Most are, but the FDA has estimated that up to 2% of prescriptions on pharmacy shelves (or, 75 million prescription drug doses) have never been subjected to the FDA’s evaluation process to ensure that the drugs are safe and effective.

Recently, LegitScript has been following the FDA’s Unapproved Drug Initiative, which seeks to identity unapproved drugs and remove them from the marketplace. Now, as part of the FDA’s Unapproved Drug Initiative, the agency has ordered all companies that make, distribute or market the drug to stop, except for the one company (URL Pharma) that has an FDA-approved version of the drug. Over the last several years, there have been several “adverse events” (that’s short-hand for illness, injury or even death) associated with unapproved versions of injectable or oral cochichine.

For patients, that means that URL Pharma’s version, called Colcrys, is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market. That drug was approved by the FDA in 2009.

But wait…what about the cost of Colcrys compared to the cost of the unapproved versions? For patients who have a difficult time affording FDA-approved Colcrys, there are options. The first is a Patient Assistance Program (PAP) and a a Co-Pay Assistance Program (CAP) that can help reduce costs for some patients. And, according to the FDA:

The (manufacturer) also has informed FDA that it will maintain the programs at a minimum until there is FDA-approved generic competition for Colcrys.

The program assistance will cover three groups of people: those with insurance; those without insurance; and Medicare beneficiaries enrolled in Part D who do not want the cost of Colcrys to contribute toward their true out-of-pocket expenditures under Part D, and can reduce the Colcrys prescription co-pay to no more than $25 per prescription. (Additional information can be found at or FDA’s action is good news for patient safety, and it’s also important that the manufacturer has committed to providing patients who need the drug with assistance, particularly until a generic version is approved.