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Use of primary gout treatment decreases after FDA action

The prescription rate of Colcrys for the treatment of gout and familial Mediterranean fever has significantly decreased following the FDA order granting Colcrys market exclusivity, according to a recently published study in the Journal of General Internal Medicine. 

“The FDA’s goals in attempting to strengthen its regulatory oversight related to unapproved drugs were laudable, but our study found that at least one expected public health benefit – changes in dangerous co-prescriptions – did not occur in the case of colchicine. By contrast, it is clear that the FDA action resulted in a reduction in colchicine initiation and an increase in cost,” Aaron S. Kesselheim, MD, JD, MPH, Harvard Medical School, and colleagues wrote.

Aaron S. Kesselheim

In 2010, the FDA granted the brand-name Colcrys (colcichine; AR Holding Co. Inc.; Takeda Pharmaceuticals USA) market exclusivity for 3 years, ordering all other makers to cease production by January 2011. This order increased the average cost of colchicine from $0.09 per table to roughly $5 per tablet. The FDA said that the manufacturing of one colchicine would decrease the rates of concomitant use of colchicine with clarithromycin, since they would require a warning label advising about the potential dangers of the two drugs interacting.

To analyze the effect that market exclusivity for colchicine had on prescription rates, health care costs and co-prescriptions of colchicine/clarithromycin, researchers conducted a retrospective cohort study of newly diagnosed gout or familial Mediterranean fever (FMF) patients enrolled with insurer UnitedHealth.

Prior to FDA approval of Colcrys, there was a 1.4% increase per month of patients being prescribed colchicine within 30 days of gout diagnosis (OR = 1.014; 95% CI, 1.011-1.018), and a 2.8% increase per month for FMF diagnoses. A 0.5% decrease per month in prescriptions for gout diagnoses (OR = 0.995; 95% CI; 0.992-0.999, P < 0.001) and a 7.6% decrease per month in colchicine prescriptions for FMF diagnoses (P = .01) followed FDA approval.

An increase in both monthly prescription drug costs ($418 vs. $651, P < .001) and health care costs ($3,406 vs. $3,534 P < .001) was experienced by patients receiving colchicine.

No change was seen in the rate of colchicine and clarithromycin co-prescription after FDA action. However, the rate of colchicine and cyclosporine co-prescription rates increased (– 0.75 monthly change; 95% CI, – 1.07 to – 0.43 vs. 0.13; 95% CI, – 0.16-0.42, P < .001).  

“The public health implications of these findings are potentially substantial … Reduction in [colchicine] use may contribute to excessive reliance alternative therapies such as non-steroidal anti-inflammatory drugs or corticosteroids — which both have important risks of their own — and unnecessary office or hospital visits by patients,” Kesselheim and colleagues wrote. – by Casey Hower

Disclosure: Kesselheim reports being supported by a Greenwall Faculty Scholarship in bioethics. Please see the full study for a list of all authors’ relevant financial disclosures.