Other safety alerts
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| The United States: FDA warns healthcare professionals not to use epinephrine nasal solutions from BPI Labs and Endo USA |
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The US Food and Drug Administration (FDA) is warning healthcare professionals not to use unapproved epinephrine (adrenaline) nasal solutions manufactured by BPI Labs LLC, in Largo, Fla., and Endo USA, in Malvern, Pa. Healthcare professionals have confused these products with FDA-approved injectable epinephrine products for intravenous use. BPI Labs and Endo USA nasal solutions products should never be injected intravenously. They are vasoconstrictor for topical application.
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 healthcare professionals accidentally injecting the nasal solution instead of the injection product.
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. Healthcare professionals use both products in hospitals and health care settings.
Endo USA voluntarily recalled on Dec. 20, 2024, its unapproved Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) due to the potential for healthcare 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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-health-care-professionals-not-use-epinephrine-nasal-solutions-bpi-labs-and-endo-usa
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 21 Dec 2024.
Ends/Friday, Jan 17, 2025
Issued at HKT 17:45
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