The FDA and PriCara have notified healthcare professionals that the Prescribing Information for Ultram (tramadol) and Ultracet (tramadol and acetaminophen) have been updated to include strengthened Warnings emphasizing the risk of suicide in patients who are addiction-prone, taking tranquilizers or antidepressant drugs, and also warns of the risk of overdosage. Tramadol-related deaths have occurred in patients with histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other central nervous system (CNS)-active drugs. Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause CNS depression. Serious potential consequences of overdosage with tramadol are CNS depression, respiratory depression and death. Tramadol has mu-opioid agonist activity, can be abused, and may be subject to criminal diversion.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm.