QT prolongation and torsades de pointes among methadone users: reports to the FDA spontaneous reporting system.

摘要: Background Recent case series have associated the synthetic opioid, methadone, with QT prolongation and torsades de pointes (TdP) ventricular arrhythmia. Study Objective To review analyze adverse events (QT TdP) reported to Food Drug Administration (FDA) determine patient characteristics, dosages of outcomes methadone-treated patients. Methods The study design was a retrieval retrospective analysis reports methadone voluntarily FDA MedWatch program from 1969 October 2002. Reports were accessed via QSCAN® (DrugLogic, Reston, VA), commercially available software interface. Results In total 5503 43 (0.78%) noted occurrence TdP 16 (0.29%) prolongation. Doses in 42/59 (71%) cases; mean dose 410 ± 349 mg/day (median 345, range 29–1680). The for 10 42 cases (29%) within recommended maintenance treatment, 60–100 mg/day. Female gender, interacting medications, hypokalemia, hypomagnesemia, structural heart disease, risk factors previously identified other drugs known cause TdP, found 44 (75%) cases. Most required hospitalization or resulted prolonged (28/59, 47%) 5/59 (8%) fatal. Conclusions Cases been system. Analysis provides evidence that can occur over wide including those usually addiction treatment. Copyright © 2005 John Wiley & Sons, Ltd.