Tramadol IV Opioid Gets Negative Vote From US FDA Advisory Panel

Joint advisory committee concludes 14 to 8 that Avenue Therapeutics’ data does not show that benefits of tramadol IV outweigh risks for acute pain management in an inpatient setting. Several panelists did not share FDA’s concern about the theoretical risk of opioid ‘stacking’ while others said delayed onset of analgesia is problematic.

Tramadol
Joint US FDA advisory committee concludes data do not show the benefits of tramadol IV outweigh its risks. • Source: Alamy

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