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Pharmacy Services

Levomethadyl hydrochloride acetate (Orlaam) Discontinued

September 10, 2003

Roxane Laboratories, Inc. is discontinuing the sale and distribution of Orlaam (levomethadyl hydrochloride acetate), a synthetic opioid agonist solution indicated for the management of opiate dependence. Levomethadyl had been associated with serious cardiac events, including QT prolongation and arrhythmias. Additional information is available at the following links:

• MedWatch Alerts
  • September 2003:
    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153332.htm
  • April 2001:
    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172550.htm
• Letter to HealthCare Professionals about cardiac adverse events:
  http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM173871.pdf

Updated
September 10, 2003; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.