The FDA in the States continues it's purge of previously grandfathered drugs. Quinine and Darvon first and now colchicine. Colchicine had until now kept under the radar, possibly because it has been used, in some form or another , for hundreds or even thousands of years. For all we know, dinosaurs may have munched on the stuff for their gout. The FDA though, obviously not history buffs, would have none of it. But one company was on the ball. URL Pharma, in anticipation of the recall, undertook it's own studies of the drug and was able to acquire exclusive marketing rights for the drug. Now rebranded as Colcrys, it will cost about $5 per pill, something like 10 times the regular price of the old stuff, and can continue to gouge users for 3 years. Americans are not amused, with good reason, but there is a good side to this story. The research done by the company actually produced important, treatment altering, and in the long term, money-saving information. (Cautionary note: I haven't actually seen the study published anywhere, but the results are available via the FDA)
Until now the time tested but obviously not scientifically tested dose of colchicine in acute gout was 1.2 mg, followed hourly until the patient got relief or developed GI side effects. In a hospital setting this meant that nurses had to check on patients hourly to reassess the situation. Not infrequently this was impossible and the dosing never actually took place. Even when successful, the prescribed endpoint was when the patient developed diarrhea. So often you had a elderly, lame patient in bed with severe diarrhea. Not a good scene. Half the time the colchicine wasn't even stopped, the diarrhea being ascribed to C difficile or other causes. This new study, however puts an end to all that. They found that 1.2mg followed one hour later by a second dose of .6 was all that was needed. Nurses around the world are rejoicing.
A second important clarification was dosing in renal failure patients. In those with a creatinine clearance of less than 30 ml/min, acute gout patients should not have a repeat dose within two weeks. For dialysis patients, a single dose of .6mg is recommended. Longer term treatment of renal patients is not discussed but FMF patients with renal failure are given a recommendation of .3 mg/day.
Lastly, it is noted that there is a very strong interaction with clarithromycin as well as lesser problems with other drugs metabolized by the CYP3A4 and P-gp systems.
So there you have it. Short term pain, at least for Americans, or at least for Americans who don't live near the border, but long term gains for all.