Oct. 18, 2018
Super-Potent Opioid Medication Will Be Abused and Kill People, Shouldn’t Be Approved, Warns FDA Advisory Committee Chair
Sufentanil Abusers Often Die After First Injection; ‘I Have Witnessed This in Resuscitating Physicians, Medical Students, Technicians and Other Health Care Providers, Some Successfully’
WASHINGTON, D.C. – In a highly unusual move, the chair of a U.S. Food and Drug Administration (FDA) advisory committee is bucking his committee’s recommendation and publicly warning that a proposed new opioid medication would be abused and start killing people as soon as it hits the market.
In a letter (PDF) to the FDA, Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, joined three Public Citizen experts in urging the agency to reject AcelRx Pharmaceuticals’ application for approval of the medication, which is called sufentanil sublingual tablet and would be used to treat moderate-to-severe acute pain in a medically supervised setting. It is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine. The committee voted 10-3 last week for the medication to be approved. Brown could not attend the meeting.
Noting that strong opioids often are abused by medical personnel, Brown wrote that if the FDA approves the medication, “I predict that we will encounter diversion, abuse and death within the early months of its availability on the market.” He added that “sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult.”
Joining Brown on the letter were Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group; Dr. Michael Carome, director of the group; and Dr. Meena Aladdin, a health researcher.
Aladdin testified before the committee, urging against approval and noting that the opioid does not offer any unique advantages over the numerous available FDA-approved opioid products for treating acute pain, but poses unique risks of serious harm if it’s misused or abused. The FDA has until Nov. 3 to decide whether to approve it.
Sufentanil has been used as an intravenous agent, approved in 1984, by clinicians only in hospital settings for general anesthesia. It is also used for epidural injections in women during labor and delivery. Brown described it as “a very potent opioid with substantial risks of respiratory depression, diversion, abuse and death. It is so potent that abusers of this intravenous formulation often die when they inject the first dose; I have witnessed this in resuscitating physicians, medical students, technicians and other health care providers, some successfully.”
“All of us strongly urge the FDA to reject this needless and dangerous opioid,” Wolfe said. “It has no truly unique benefits and will only worsen the opioid epidemic in this country.”
What’s more, the FDA lacks the ability to enforce safeguards after a medication is marketed, Brown said.
“Once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health,” he wrote. “I would never consider this product for marketing in the U.S.”
Further, the committee review process was flawed. The full Drug Safety and Risk Management (Advisory committee, of which Wolfe was a member from 2008 to 2012, should have been at the meeting, the group wrote. Not including those members increased the odds of a vote for FDA approval.
Read the letter here (PDF.)