The United States Food and Drug Administration (USFDA) has warned health care professionals not to use unapproved epinephrine nasal solutions. According to a statement issued by the federal agency, the doctors have confused nasal solutions manufactured by BPI Labs LLC, in Largo, Fla., and Endo USA, in Malvern, Pa with FDA-approved injectable epinephrine products for intravenous use. Epinephrine nasal spray is usually given at the first sign of an allergic reaction.
BPI Labs and Endo USA nasal solutions products should never be injected intravenously, FDA warned.
“The nasal solution and injectable products have similar packaging and containers and are manufactured by the same companies. The similarities of the bottle and packaging labels between the nasal product and the sterile injectable make it difficult to distinguish them from each other which can lead to health care professionals accidentally injecting the nasal solution instead of the injection product,” it stated on Thursday.
Unlike an injectable drug, nasal solutions are not required to be sterile. Injecting a non-sterile drug can lead to infection, which can be life threatening for certain patients, the US body maintained.
“Endo USA voluntarily recalled on Dec. 20, 2024, its unapproved Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) due to the potential for health care professionals accidentally injecting the nasal solution instead of the injection product. FDA recommended BPI Labs recall its unapproved EPINEPHrine Nasal Solution on Dec. 12, 2024. The agency followed up with the company several times to reiterate this recommendation. The latest adverse event report FDA received involved the product with BPI Labs’ most recently revised label. The company has not acted to remove its unapproved drug from the market,” it stated.
FDA has received more than 25 reports since 2016 stating confusion between unapproved epinephrine nasal solution and approved epinephrine injection involving similarities in product labels and containers. Recently in 2024, the agency received a report involving a patient who received the nasal solution as an injection.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program, it added.
