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May 26, 2010: Warning Label Update Ultram and Ultracet

Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for Ultram (tramadol hydrochloride) and Ultracet (tramadol hydrochloride/acetaminophen).

These drugs contain Tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. FDA suggests that tramadol is subject to illegal use or abuse, and can be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause central nervous system depression.

The strengthened Warnings information warns of the risk of overdosage and emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs. Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs.

Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death.

The Law Firm of Eric H. Weinberg has been successfully litigating pharmaceutical drug cases for over twenty years on behalf of injured persons. If you or a loved one has concerns about personal injuries related to the use of a particular pharmaceutical drug you can request a Free Case Evaluation or contact us toll free at 1-877-934-6274.

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