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Single-Ingredient Oral Colchicine Video: Transcript

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We’re at the U.S. Food and Drug Administration with the Division of Drug Information  pharmacists who answer hundreds of questions daily about drug products and FDA actions.  Today they are discussing important new information about colchicine.  This is FDA Drug Info Rounds, a program by pharmacists for pharmacists.

We have been getting a lot of calls and emails lately about colchicine. A drug that’s been used since the 1930s without FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.

However, in 2009, FDA approved the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever and acute gout flares. This approval ensures, for the first time that oral colchicine is safe, effective and properly labeled. This wasn’t the case with the previously unapproved oral colchicine.

One of the most common questions patients are asking is “Why has the cost of my colchicine increased significantly ever since Colcrys has been approved?”  They say that for years they’ve been paying the same low price everytime they pick up their colchicine prescription.        

Of course we know that price affects access. However, unlike many countries around the world, FDA has no statutory authority to control the prices charged for marketed drugs in the United States.  These prices are established by manufacturers, distributors, and retailers.

Right and besides price, there is the factor of whether a drug has FDA approval. Carefully designed clinical trials have repeatedly demonstrated that the safety and effectiveness of drugs cannot be adequately established from anecdotal evidence or consumer or prescriber preferences. Plus drugs that have not been approved by the FDA:

  • may not be safe or effective
  • may have been manufactured under sub-standard conditions
  • may contain too much or too little (if any) active ingredients
  • and may not have the necessary labeling information and warnings.

If these oral colchicine products are unapproved, why are they allowed on the market?

There are a few products on the market that pre-date existing FDA laws and regulations. Colchicine is one of these products. FDA has not, to date, taken any regulatory action to remove unapproved oral colchicine from the market. However, since FDA’s Unapproved Drugs Initiative announced in June 2006, marketers of unapproved drugs have been on notice that FDA is placing a high priority on addressing risks from unapproved drugs.  FDA is systematically and responsibly ensuring that all products on the U.S. prescription drug market become compliant with current FDA approval requirements for safety, efficacy and quality.   

The agency is aware of 21 firms that manufacture and distribute unapproved oral colchicine. So far, only one, Mutual Pharmaceuticals has chosen to take the responsible step of seeking FDA approval. 

Another issue that can be confusing to patients is that many of them believe these unapproved products are generic versions of Colcrys, and work just as well. To be clear, these unapproved colchicine products are not generic versions of Colcrys.  By definition, generic drugs are those evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference product.  These unapproved products have not been evaluated or approved by FDA.  They are therefore unapproved drugs, not generic medications, and neither their safety nor their efficacy can be ensured.        

Why is FDA concerned about safety and efficacy when colchicine has been on the market for years?   

Let’s look more closely at this issue.

During the drug review process for Mutual’s product Colcrys, FDA identified two previously uncharacterized safety concerns associated with the use of colchicine. 

First, FDA analyzed safety data from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity.  

Second, data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used.  In addition, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose. Because these new data provide actionable and important information for healthcare professionals to guide dosing, and to reduce potential adverse events, FDA highlighted this in the approved prescribing information for Colcrys. The unapproved products do not include this information. 

To ensure the safe use of colchicine, FDA recommends that healthcare professionals:

  • Not use P-glycoprotein (P-gp) or strong CYP3A4 inhibitors in patients with renal or hepatic impairment who are currently taking colchicine.
  • Consider a dose reduction or interruption of colchicine treatment in patients with normal renal and hepatic function if treatment with a P-gp or a strong CYP3A4 inhibitor is required.
  • Prescribe the FDA-approved Colcrys dose for the treatment of acute gout flares: which is 1.2 mg followed by 0.6mg in 1 hour (for a total 1.8mg).
  • Refer to Colcrys’ approved prescribing information for specific dosing recommendations and additional drug interaction information.
  • Review the Medication Guide for important safety information.

Without this review by FDA, outdated assumptions of what is safe and effective for treatment with oral colchicine would have remained unchecked, and patients would have continued to suffer from adverse reactions such as severe gastro-intestinal complications -- and even death -- needlessly.

Ok, if healthcare professionals want to switch their patients to approved Colcrys, the increase in cost is still a major concern. What can pharmacists recommend to their patients?  

The manufacturer of Colcrys, Mutual Pharmaceuticals, has started the Colcrys Patient Assistance Program. The program helps patients with limited financial means save on Colcrys prescriptions.  Unlike other patients’ assistance programs that may primarily target patients at or near the poverty level, Mutual’s tiered program is designed to help patients in a variety of socio-economic situations.  

By making healthcare professionals aware of the differences between unapproved colchicine and the approved product, Colcrys, and by giving them a plan to help off-set the cost, they can improve the health of their patients while helping them save money.     

Thanks for joining the FDA pharmacists at their Drug Info Rounds, the first of a series inside the FDA. This is our FDA program of pharmacists helping pharmacists educate consumers, so they can make better medication choices. 

To report medication adverse events call 1-800-332-1088 or go online to www.fda.gov/medwatch.   If you have any questions, you may reach FDA’s Division of Drug Information by calling 1-888-463-6332 or email us at druginfo@fda.hhs.gov.