FDA Colchicine Review Provides Helpful Information
July 18, 2011 by Lynn.
Concerned that older drugs that have been in use since before the inception of a stringent approval process in the 1960's may not meet current standards for safety, effectiveness, quality and labeling, the FDA launched the Unapproved Drug Initiative in 2006.
Pharmaceutical companies manufacturing older, unapproved medications were expected to put them through expensive clinical trials to win formal FDA approval. In return, the companies would be given exclusive market rights for a specified time period to allow them to recoup their investment.
One of those unapproved drugs was the gout medication colchicine. Because colchicine has been in use since the 1960s, it - like many other commonly prescribed drugs including morphine, phenobarbitol and nitroglycerine - never went through the current FDA review and approval process.
In 2009, URL Pharma successfully underwent the rigorous approval process and received exclusive rights to market its brand name colchicine, Colcrys, for gout for three years, and for familial Mediterranean fever for seven years.
In 2010, over twenty other US pharmaceutical companies were ordered to stop manufacturing the gout drug. Almost immediately, the price of one colchicine tablet soared from under 10 cents to almost $5 in the US.
In the public uproar over the massive increase in the price of colchicine following the disappearance of cheaper generic colchicine from the American market, many have lost sight of two important findings arising from the FDA's stringent review and approval process.
Here are the two findings and related recommendations, taken from the FDA's own website:
During the drug review process for [the] product Colcrys, the FDA identified two previously uncharacterized safety concerns associated with the use of colchicine.
1) FDA analyzed safety data for colchicine 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 reported 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.
2) 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.
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).
In plain English, the FDA concerns are:
- Taking PGP inhibitors (such as clarithromycin, erythromycin, cyclosporine and verapamil) or a strong CYP3A4 inhibitor (some types of protease inhibitors, antifungals and antibiotics) along with colchicine may increase the risk of colchicine toxicity in patients with kidney or liver problems.
- A lower colchicine dose than has generally been prescribed is just as effective, and poses less risk of side effects.
While this is not new information, it is still of interest to those who use or prescribe both name brand Colcrys and generic forms of the gout medication, such as colchicine from Canada. To view a video on the FDA's findings and recommendations on Colcrys (brand name colchicine) CLICK HERE.<
Filed under: Colchicine FDA.
Tags: fda colchicine, colchicine Canada, colchicine for gout, colchicine medication.
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