September 9, 2020

FDA Approves Two New Opioids

The FDA recently approved Olinvyk (oliceridine) injections for intravenous (IV) use for the management of patients with acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate.

According to the FDA-approved drug label, dosing should be based on severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. The lowest effective dose for the shortage duration consistent with individualized patient treatment goals should be used.

In related news, the FDA also approved Qdolo (tramadol hydrochloride) oral solution for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

At this time, only a letter of approval has been published by the FDA, and the drug label with more detailed information is still pending.

However, like all other opioids, Olinvyk and Qdolo expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Patient risk should be assessed prior to prescribing, with regular monitoring for the development of concerning behaviors or conditions. Serious life-threatening or fatal respiratory depression may occur, which prescribers should monitor for.

Concomitant use of any opioids, including Olinvyk or Qdolo, with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

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