Pharmacy Services
Tramadol (Ultram, Ultracet) - Label Updates
May 25, 2010
FDA and Ortho-Mcneil-Janssen informed health care professionals of updates to the Warnings and Drug Abuse and Dependence sections of labeling for Ultram (tramadol) and Ultracet (tramadol/ acetaminophen). The new information cautions about suicide risk, overdose risk, and potential for misuse, abuse, and diversion associated with tramadol. Do not prescribe tramadol for patients who are suicidal or addiction prone. Exercise caution when considering tramadol for patients taking tranquilizers or antidepressants, for those who use alcohol in excess, or for those with emotional disturbances or depression. Deaths have occurred in patients treated with tramadol who had a history of emotional disturbance, suicidal ideation, or misuse of alcohol, tranquilizers, or other drugs that act on the central nervous system (CNS). Tramadol can have additive CNS depressant activity in combination with alcohol or other drugs that cause CNS depression. Tramadol is a mu-opioid agonist with abuse and diversion potential.
Additional information is available at:
- FDA Medwatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm213264.htm - Dear Healthcare Professional Letter – Ultram:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM213265.pdf - Dear Healthcare Professional Letter – Ultracet:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM213266.pdf
Updated
May 25, 2010, University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
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