The FDA was wise to approve a new opioid
The FDA was wise to approve a new opioid
A dispenser and tablet for Dsuvia.
Photo:
Craig Sherod / Associated Press
Last week, the Food and Drug Administration approved Dsuvia, a powerful new opioid. The typical scenario for use is in wounded soldiers who are transported out of the battlefield who lack intravenous access for an injection or drip and who can not swallow medication. With a syringe-like applicator, the medical staff places the rapid dissolving pill under the patient's tongue.
A new analgesic option for American soldiers with terrible pain should be welcomed as a pharmaceutical victory. But Dsuvia has been attacked. It contains sufentanil, a synthetic opioid up to 10 times more potent than fentanyl and about 1,000 times more potent than morphine.
"Right now, in the United States, I do not think there's any good reason to put another powerful opioid on the streets," said Raeford Brown Jr., a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the FDA. Advisory Committee on Anesthetic and Analgesic Products. Despite their warnings, the advisory committee voted 10-3 to recommend its approval.
"It is true that Dsuvia will worsen the opioid epidemic," said Sidney Wolfe, founder of Public Citizen's Health Research Group. Massachusetts Senator Ed Markey has asked the FDA to "stop the approval of this dangerously unnecessary opiate medication."
They are wrong, the FDA made the right call. Dsuvia will not be "on the street", but will be available only for hospitalized patients. Outpatient pharmacies will not store it. Patients can not take it home. The recommended limit of administration is three days. The only realistic potential abusers in Dsuvia are the medical staff, who have had access to liquid sufentanil in hospital pharmacies since the drug was approved in 1984 for intravenous and epidural use.
The dangerous hyper-active drugs now on the street, fentanyl and carfentanil, which are 100 times more potent and used to calm large animals, are illicitly manufactured in China and Mexico. For the past four years, heroin and fentanyl have been the main drivers of overdose deaths.
A strange calculation marks the controversy of Dsuvia. Critics say that the benefit to soldiers in excruciating pain is offset by the risk to hospital staff who could deliberately abuse him, the same professionals who have sworn not to harm and who already have direct access to this medication and others.
Protecting the public from drug abuse and addiction to licit and illicit opioids requires perspective. The appropriate response to health professionals who abuse opiates is the treatment of addiction and disciplinary action by state health boards, not the restriction of medication for patients in need.
Dr. Satel is a resident academician of the American Enterprise Institute and professor of psychiatry at Yale.
It appeared on November 8, 2018, print edition.
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