Also on the medication front is a newly approved drug called pegloticase (Krystexxa), which might be a good option for lowering serum uric acid levels and preventing gout attacks in patients who cannot use allopurinol, said Dr. Weinstein.
If a gout attack strikes during hypouricemic therapy, Dr. Weinstein cautioned, "Don’t change anything – don’t stop the allopurinol, don’t change the diuretic. ... Just add the steroid or whatever you’ve chosen for an acute attack. Treat the attack like any other."
Colcrys, the Costly Alternative
Physicians who have long had colchicine as part of their armamentarium for the treatment of acute gout and, more important, for gout-flare prophylaxis, are coping with the loss of an array of traditional colchicine products and the current availability of only one, recently approved formulation – Colcrys – which is 50 times the cost of the earlier versions.
The winnowing of options is a result of the Food and Drug Administration’s Unapproved Drugs Initiative of 2006 that aims to bring previously grandfathered prescription drugs in compliance with current FDA approval requirements for safety and efficacy.
In July 2009, the FDA approved URL Pharma to market Colcrys for treatment of acute gout flares and prophylaxis of flares of familial Mediterranean fever. The agency gave the company 3 years of marketing exclusivity for the acute gout indication. The FDA approved an indication for gout flare prophylaxis several months later. Then, in the Oct. 1, 2010, Federal Register, the agency announced its intention to "take enforcement action" against the manufacture and distribution of unapproved single-ingredient oral colchicine products.
The cost of Colcrys caused an uproar in the rheumatology community, and the American College of Rheumatology worked with URL Pharma to cut prices to patients finding it hard to afford the drug.
College officials have also been encouraging manufacturers of unapproved colchicine products to submit new drug applications for the gout prophylaxis indication. According to the college, URL Pharma does not have exclusivity for this indication, and one other manufacturer has filed an application to market its product for this indication.
In the meantime, the FDA has been calling attention to safety concerns identified during its review of Colcrys, namely, a risk for severe drug interactions in certain patients treated with colchicine and concomitant P-gp or strong CYP3A4 inhibitors such as clarithromycin. Also, a dosing study submitted as part of the Colcrys application indicated that low-dose colchicine (1.8 mg over 1 hour) was a better treatment for acute gout than was a high-dose regimen (4.8 mg over 6 hours).
Dr. Rachow and Dr. Taler said they had no conflict of interest to disclose on this topic. Dr. Weinstein disclosed that he has received research grants from Savient Pharmaceuticals, the maker of pegloticase, for a clinical study, but not for any therapeutic studies.