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September 24, 2024

FDA Approves Zurnai and Neffy

The FDA approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose.

Zurnai is a single-dose, pre-filled auto-injector and is available only by prescription. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation and low blood pressure (hypotension).

The use of nalmefene hydrochloride in patients who are opioid dependent may result in opioid withdrawal characterized by the following signs and symptoms: body aches, diarrhea, fast heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

The FDA also approved Neffy® (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis).

Allergic reactions that occur in the workplace can be covered by workers’ comp under certain situations. For instance, exposure to chemicals, materials, or environmental conditions encountered while performing workplace duties could cause an allergic reaction. In scenarios like this, medications for the treatment of allergic reactions can be covered by workers’ comp, making it important to understand the different medications available to treat anaphylaxis.

Neffy is unique in that it is the first nasal spray formulation of epinephrine, giving patients a needle-free delivery device. Neffy is a single dose nasal spray administered into one nostril. As with other epinephrine injection products, a second dose (using a new nasal spray to administer neffy in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen.

Those with certain nasal conditions (e.g., nasal polyps, prior nasal surgery, sulfite allergy) may not be a good candidate for use due to possible changes in absorption and reduced effectiveness.

Common side effects of Neffy include throat irritation, tingling nose, headache, nasal discomfort, feeling jittery, tingling sensation, fatigue, tremor, runny nose, itchiness inside the nose, sneezing, abdominal pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea and vomiting.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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