Colchicine deaths blamed on pharmacy error

NEW YORK, Oct 12 (Reuters) Two recent deaths, and possibly a third, from intravenous colchicine therapy at an alternative medicine clinic were the result of a compounding pharmacy error, health authorities reported in the Morbidity and Mortality Weekly Report.

Intravenous colchicine is an accepted, but not an FDA-approved, treatment for acute gout symptoms. In recent years, however, it has been used by alternative medicine practitioners to treat chronic back pain. The drug has well-known side effects and IV doses higher than the standard 2-4 mg single dose used per gout episode have been linked to life-threatening toxicity.

In the current report, health authorities from poison centers in Washington and Oregon yesterday describe two patients who died after receiving intravenous colchicine for back pain.

Both patients, a 77-year-old woman from Washington and a 56-year-old woman from Oregon, received the treatment from the same alternative medicine clinic in Portland, Oregon.

An investigation into the deaths, which took place between 2006 and 2007, revealed that a measuring error by the Texas compounding pharmacy supplying the clinic resulted in blood colchicine concentrations that were higher than the standard level. In one case, the blood level exceeded the recognized therapeutic level by more than eight-fold.

A third death involving a patient who took colchicine obtained from the same clinic appears to have also resulted from the compounding error, the researchers note. The patient had a history of heart disease and recently had a stent implanted, so colchicine poisoning was not initially suspected.

Since these cases surfaced, all remaining vials of colchicine were removed from the clinic and all colchicine sold or produced by the Texas compounding pharmacy in 2007 have been recalled. No further deaths have been reported.

These events ''highlight the risk for serious health consequences from use of IV colchicine for back pain,'' the report concludes, and ''underscore the potentially fatal ramifications of errors by compounding pharmacies, which generally are not subject to the same oversight and manufacturing practices as pharmaceutical manufacturers.'' REUTERS NY HS0924