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Bernard A. Schwetz, DVM,PhD

JAMA. 2001;285:2705.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA and Roxane Laboratories Inc, Columbus, Ohio, have warned prescribers that use of levomethadyl acetate hydrochloride (Orlaam), a drug for treatment of opiate addiction, has been associated with QT prolongation and severe arrhythmia. The drug's labeling will be changed to emphasize that due to its potential for possibly life-threatening proarrhythmic effects, Orlaam should be used only to treat opiate-dependent patients who fail to show an acceptable response to other adequate treatments of addiction.

The labeling change is based on 10 cases of serious arrhythmia, including seven cases of known or suspected torsades de points, that have been reported since the drug's approval in 1993. Similar reports have been received by European agencies. As a result, Orlaam is contraindicated in patients with known or suspected arrhythmia. Prior to induction/initiation of Orlaam therapy, all patients should undergo a 12-lead electrocardiogram to determine the presence of QT prolongation.

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Acting Principal Deputy Commissioner
Food and Drug Administration

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