November 17, 2021

FDA Approves Zimhi and Seglentis

The FDA approved two new drugs – one to reverse opioid overdose and one to treat acute pain – both of which will have a significant impact for workers’ comp.

FDA Approves Zimhi for Opioid Overdose Reversal

Zimhi™ (naloxone hydrochloride) injections have been approved for the emergency treatment of known or suspected opioid overdose, as characterized by respiratory depression (slow and ineffective breathing) and/or central nervous system depression (decreased breathing, decreased heartrate, loss of consciousness).

Opioid pain medications are commonly used in workers’ comp, and even when used appropriately, prescription opioids can cause adverse events, including fatal overdose. Naloxone medications that can reverse opioid overdose and prevent death and other significant harm are of great value, and they are often prescribed to opioid patients. With rising opioid overdoses reported since 2019, drug development for naloxone products has increased.

Zimhi is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride through the muscle or under the skin. Zimhi is not a substitute for emergency medical care, and when used to reverse an opioid overdose, emergency medical care should still be utilized.

Like any naloxone medication, Zimhi can cause opioid-dependent individuals to experience opioid withdrawal, characterized by rapid onset of severe body aches, vomiting, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, nausea, nervousness, irritability, shivering, abdominal cramps, weakness, and increased blood pressure.

FDA Approves Seglentis for Acute Pain

The FDA approved Seglentis (celecoxib and tramadol hydrochloride) tablets for the management of acute pain that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Seglentis is a combination of an opioid agonist and an NSAID (nonsteroidal anti-inflammatory drug), and therefore comes with warnings, precautions, and other concerns tied to both drug classes.

NSAIDs and opioids are both commonly used in workers’ comp for the treatment of pain, often at the same time. This new combination drug could potentially appear in claims, especially if providers see a benefit of using one combination prescription, instead of multiple prescriptions.

Like other opioids, Seglentis exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. The FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for this product, consistent with other opioids.

Like other NSAIDs, Seglentis can increase the risk of serious or fatal cardiovascular events, such as heart attack or stroke, and gastrointestinal events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Risk is increased with chronic use.

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