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The US Food and Drug Administration (FDA) is alerting patients, caregivers and health care professionals that EpiPen 0.3 mg and EpiPen Jr 0.15 mg auto-injectors, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to:
In a letter to health care professionals from Pfizer, the manufacturer of the EpiPen, and Mylan, detailed how these devices may activate prematurely if the blue safety release is removed using a sideway force. For example, a user may try to hold a device with only one hand and try to remove the blue safety release with their thumb in a sideways force. Prior to use, the blue safety release should be removed by pulling straight up with one hand and holding the device with the other hand.
A very limited number of EpiPen devices also may have a blue safety release that is slightly raised. If the blue safety release is raised, the device may activate prematurely, which could potentially delay or prevent emergency treatment when needed.
Additionally, in some cases EpiPen devices may not slide out of their carrier tube easily, or potentially at all, due to a slight deformation on the rim of the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the auto-injector from the carrier tube.
The letter also describes specific user errors that can delay or prevent the administration of the intended dose of epinephrine. For example:
It is important for health care providers, patients and caregivers to periodically review the EpiPen user instructions and practice using the EpiPen trainer to ensure proper understanding and utilization of the EpiPen auto-injector.
It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure the blue safety release is not raised and that the device can be easily removed from the carrier tube.
Patients should contact Mylan Customer Relations at 800-796-9526 if they find an issue with their auto-injector and to obtain a replacement at no additional cost. Pharmacists should inspect the products before dispensing them to patients to ensure quick access to the auto-injector and should not dispense any product which does not easily slide out of its carrier tube or has a raised blue safety release. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.
The FDA is aware of adverse event reports associated with EpiPen products. The FDA asks health care professionals and consumers to report any adverse reactions or quality problems to the FDA’s MedWatch program:
The College is advising patients that if there is a problem with their EpiPen auto-injector, they should contact their allergist, as alternatives are available.