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From the Food and Drug Administration
June 6, 2001

Labeling Changes for Orlaam

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Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001American Medical Association

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JAMA. 2001;285(21):2705. doi:10.1001/jama.285.21.2705-JFD10005-3-1

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.

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