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U.S. Department of Health and Human Services


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Questions and Answers for Patients and Healthcare Providers Regarding Single-ingredient Oral Colchicine Products


What action is FDA taking regarding single-ingredient oral colchicine drug products?
The U.S. Food and Drug Administration (FDA) has ordered companies to stop marketing unapproved single-ingredient oral colchicine products. Under the notice published in the Federal Register, firms marketing any unapproved single-ingredient oral colchicine products must stop manufacturing these products within 45 days and must stop shipping this unapproved product in interstate commerce within 90 days. After these dates, all single-ingredient oral colchicine products must have FDA approval to be manufactured or shipped interstate.

Why is FDA taking this action?
FDA is taking this action as part of its continuing effort to ensure that drugs marketed in the U.S. are safe, effective, of good quality, appropriately labeled, and have the required FDA approval.  For many years, all single-ingredient oral colchicine products were unapproved. In 2009, Mutual Pharmaceutical (Mutual) obtained approved applications for the use of single-ingredient oral colchicine for the daily prophylaxis of gout flares, for the treatment of acute gout flares, and for the treatment of Familial Mediterranean Fever (FMF). The approved product is being marketed under the name Colcrys. No other single-ingredient oral colchicine products have been evaluated and approved by FDA. 
Consistent with the policies FDA announced in June 2006, removing drugs with potential safety risks, and removing unapproved drugs that present direct challenges to the new drug approval system are priorities in taking enforcement action. The drug approval system is designed to avoid risks associated with potentially unsafe, ineffective, and fraudulent drugs.
Data submitted from post-marketing adverse event databases showed that half of non-overdose colchicine fatalities were related to the combination of colchicine and clarithromycin. Based on information submitted to the Agency, new specific dose modification and reduction recommendations are in the approved colchicine label. FDA has not reviewed the labels of unapproved products for accuracy, proper dosing instructions, or drug interaction warnings. Unapproved products have unapproved labeling, and may not contain appropriate dosing and drug interaction information. As part of the Agency’s initiative to bring unapproved, marketed products under the usual regulatory framework, a new clinical trial for acute gout found that a lower dose than had been considered the standard of care was just as effective for the treatment of an acute gout flare, and resulted in fewer adverse events. The approved labeling reflects this newly discovered information.
The expected risks associated with the use of unapproved products that contain colchicine are potentially greater because the quality, safety, and efficacy of unapproved formulations have not been demonstrated to FDA. For example, the ingredients and bioavailability of unapproved products have not been submitted for FDA review, nor has FDA had the opportunity to assess the adequacy of their chemistry, or manufacturing specifications. 
Finally, unapproved single-ingredient oral colchicine products present direct challenges to the prescription drug approval process in that they have not been reviewed by FDA, and they compete with an approved product (Colcrys). Targeting drugs that challenge the drug approval system protects the integrity of, and makes it more likely that firms will comply with, FDA’s drug approval requirements. 
What effect will FDA’s action have on people who use single-ingredient oral colchicine?
Single-ingredient oral colchicine will remain available to consumers because FDA has approved Colcrys for the daily prophylaxis of gout flares, for the treatment of acute gout flares, and for the treatment of Familial Mediterranean Fever (FMF). Mutual is aware of the market demand, and has told the Agency that it will be able to meet the demand. Because these products are approved, consumers purchasing them can be assured that FDA has reviewed their safety, effectiveness, quality of manufacturing, and accuracy of labeling.
What help is available to patients and healthcare providers who are concerned about the cost of the approved colchicine?
The manufacturer of approved single-ingredient oral colchicine (Colcrys) has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure that all patients will be able to continue affordable access to colchicine, and has informed FDA in a letter that it will maintain the programs at a minimum until there is FDA-approved generic competition for Colcrys. The PAP covers patients with annual incomes up to 6 times the Federal Poverty limit, patients without insurance, and certain Medicare beneficiaries enrolled in Part D.  The CAP applies to insured patients who do not qualify for the PAP, and permits eligible patients to reduce their co-payment to no more than $25. Patients can receive their Colcrys co-pay support automatically at many participating pharmacies, can get a coupon from their healthcare provider, or can download and print a coupon by visiting www.colcrys.com disclaimer icon to present to their pharmacist when filling a Colcrys prescription.
For questions or to obtain assistance, patients should contact the Colcrys Patient Assistance Program at www.needymeds.org disclaimer icon or www.colcrys.com disclaimer icon, or call 1-888-811-8423 from 8:00 am to 6:00 pm Eastern Time, Monday through Friday.   The PAP form can be accessed at: http://www.needymeds.org/papforms/colcry1304.pdf disclaimer icon.
Are there any generic single-ingredient oral colchicine products available?
There are no generic versions of single-ingredient oral colchicine on the market. Generic drugs are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.  Generic drugs must be approved by FDA, to assure that the approved generic drug products have met the same rigid standards as the innovator drug (in this case, Colcrys). Generic drugs approved by FDA have the same quality, strength, purity and stability as brand-name drugs.  And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand-name drugs.  Any single-ingredient oral colchicine product, other than Colcrys, that is currently being marketed is an unapproved drug that has never been evaluated by the Agency.
Is it safe to use the unapproved products?
The safety of unapproved drugs is unknown. Approved single-ingredient oral colchicine (Colcrys) has labeling that has been specifically reviewed and approved by FDA, and that reflects the risks, benefits, and safe use of this drug. This information may not be contained in the labeling of the unapproved products. 
The drug approval process enables FDA to evaluate the drug’s formulation, manufacturing process, and labeling, as well as any changes that occur after approval.  Unapproved drugs not subject to this evaluation may not be safe, effective, and adequately labeled. They may also be substandard – lacking required identity, strength, quality, and purity.
How can people tell the difference between FDA-approved and unapproved products?
At this time, the only approved single-ingredient oral colchicine product is Colcrys, which is manufactured by Mutual. Colcrys is a purple film-coated, capsule-shaped tablet debossed ‘AR 374’ on one side and scored on the other side. Single-ingredient oral colchicine products marketed by any other firm are unapproved.
Are there other forms of colchicine available to consumers?
FDA-approved colchicine is currently available in an oral dosage form as a single-ingredient and combination product. In addition to single-ingredient Colcrys, there are several FDA-approved oral combination products containing colchicine and probenecid indicated for the treatment of chronic gouty arthritis when complicated by frequent, recurrent acute attacks of gout. Combination products containing colchicine are not covered by this notice. 
Colchicine had also been available in an unapproved intravenous injection form. However, because of toxicities associated with the use of intravenous colchicine and the emergence of safer alternative therapies, FDA ordered companies to stop marketing unapproved versions of this form of the drug in February 2008.

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