November 9, 2018

FDA Approves New Opioid, Dsuvia

The FDA has approved Dsuvia (sufentanil) sublingual tablets for use in medically supervised healthcare settings such as hospitals, surgical centers, and emergency departments for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Sufentanil is five-to-ten times stronger than fentanyl, and this approval has caused some drug experts to question the FDA’s decision to approve the drug. The FDA initially declined to approve this drug until additional safety data was collected and changes were made to language regarding Directions and Use to address use-related errors. In fact, the head of the FDA’s advisory committee on painkillers argued the drug would likely worsen the opioid crisis.

According to the FDA-approved label, Dsuvia is not for home use, and treatment should be discontinued before patients leave certified medically supervised healthcare settings. Dsuvia should be discontinued after no more than 72 hours.

Accidental exposure or ingestion of Dsuvia can result in respiratory depression and death. Dsuvia should only be available through the restricted Dsuvia REMS (risk evaluation and mitigation strategy) program. Dsuvia exposes users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Patients with breathing disorders such as acute or severe bronchial asthma and COPD should not take Dsuvia.

For more information, read the FDA-approved drug label.

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