WASHINGTON, D.C. – The U.S. Food and Drug Administration’s (FDA) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee are meeting today to consider the approval of the first intravenous (IV) dosage form of tramadol, a widely used but inadequately regulated opioid, to be used for treatment of acute pain in a medically supervised health care setting such as a hospital or clinic after surgery or in a physician’s office. Dr. Sidney Wolfe, senior advisor to Public Citizen’s Health Research Group, testified to the committee that this treatment should not be approved.
The agency previously has rejected the drug but has allowed its manufacturer, Avenue Therapeutics, to present its case for approval to the advisory committees, despite serious problems found in clinical trials.
The IV dose of tramadol takes a median time of 106 minutes after surgery for meaningful pain relief, compared to 42 minutes for IV morphine. Because of this, the FDA suggests that an ideal IV analgesic intended to treat acute pain should have a relatively quick onset of pain relief, particularly for an IV opioid given the known safety concerns of respiratory depression, misuse, abuse, addiction, and death generally associated with opioid use.
The increased incidence of respiratory impairment with tramadol IV administration was of clinical concern because these adverse events, if not treated promptly, can lead to brain injury and death. From a respiratory safety perspective, tramadol IV appears no better and, with dosing regimens studied, potentially worse than morphine IV.
“Because IV tramadol has no unique benefits, but unique risks, the advisory committee should unanimously vote against its approval,” said Dr. Wolfe.
See Dr. Wolfe’s testimony here.