Nasal Solutions Mistakenly Injected: The USFDA has issued a critical warning about the potential for serious harm due to the misadministration of unapproved epinephrine nasal solutions. These products, manufactured by BPI Labs and Endo USA, are packaged in a way that can be easily confused with FDA-approved injectable epinephrine.
Risk of Infection:
- Nasal solutions are not sterile, unlike injectable medications.
- Injecting a non-sterile solution can lead to severe infections, potentially life-threatening for some patients.
- The risk is heightened as both nasal and injectable products are used in healthcare settings.
Endo USA Recalls, BPI Labs Refuses:
- Endo USA has voluntarily recalled its unapproved epinephrine nasal solution.
- BPI Labs, despite repeated warnings, has failed to remove its unapproved product from the market.
Patient Safety Concerns:
- The FDA has received over 25 adverse event reports since 2016, including a recent case where a patient was mistakenly injected with the nasal solution.
Urgent Action Needed:
- The FDA urges healthcare professionals to be vigilant and report any adverse events or quality issues related to these products through the MedWatch program.
