1. Montano, Anthony L.

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As a nursing student with 13 years of experience as an army flight medic and emergency medical technician, I've witnessed the Food and Drug Administration (FDA) approve and recall many medical devices. "Nasal Spray Formulation of the Opioid Antagonist Naloxone Approved" (Drug Watch, April) claims that intranasal administration is as effective as intramuscular administration, if not more effective. This is based, however, on the assumption that the nasal passage is clear, intact, and uncompromised. If the nasal passage is compromised, there are no alternative administration routes for the intranasal device. This wouldn't occur with the intramuscular auto-injector, which can be used in numerous locations. Additionally, Evzio, the FDA-approved naloxone intramuscular auto-injector, has a safeguard in place to prevent the accidental discharge of medication during normal handling, as well as instructions printed directly on the device-safeguards not in place on the approved nasal spray device.1 I believe that significant details such as these are easily overlooked when medical devices are granted FDA fast-track designation.


Anthony L. Montano


Hayward, CA




1. Kaleo, Inc. Prescribing information: Evzio (naloxone hydrochloride injection) auto-injector for intramuscular or subcutaneous use. Richmond, VA; 2014 Apr. [Context Link]