Suicide Risk with Tramadol

Ortho-McNeil-Janssen is notifying healthcare professionals about strengthened warnings for Ultram (tramadol hydrochloride) and Ultracet (tramadol hydrochloride/acetaminophen). These drugs contain tramadol, which is a synthetic opioid analgesic used to manage chronic pain.

The new warnings emphasize that certain patients have a higher risk of suicide if they are treated with tramadol. Because of this, tramadol should not be prescribed for patients who are suicidal or addiction-prone. In addition, tramadol should be prescribed with caution for patients who are taking tranquilizers or antidepressants, who use alcohol excessively, or who suffer from emotional disturbances.

The labeling changes also emphasize the additive effects and risk of overdose if tramadol is used with alcohol or other CNS depressants, including sedatives, tranquilizers, muscle relaxants, and tricyclic anti-depressants. The revised warnings also highlight the possibility that the drug could be diverted, misused and abused.

FDA Patient Safety News: September 2010

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=102#7

Category:

Education

Tags:

• Ultram
• Ultracet
• tramadol
• side effects
• overdose
• chronic pain
• drug
• FDA