EpiPens May Malfunction, Delaying Life-Saving Med, FDA Warns

Megan Brooks

March 25, 2020

Epinephrine auto-injectors (EpiPen 0.3 mg, EpiPen Jr 0.15 mg, and generics), used to treat severe allergic reactions, could potentially have delayed injections or fail to inject as intended as a result of device design issues or operator error, the US Food and Drug Administration (FDA) says. 

In an alert posted on its website, the agency says the devices could activate prematurely if "sideways force to remove the blue safety release" is applied, or if the device has a "raised blue safety release." In addition, some devices may be hard to remove from the carrier tube and user error is also a concern.

"Since EpiPen is administered for severe and potentially life-threatening allergic reactions, anything that prevents or delays the administration of the intended dose of epinephrine could result in a high risk to the patient, including the risk of death," Mylan and Pfizer, which make the devices, said in a letter to healthcare providers.

The letter provides more detail on how epinephrine auto-injectors may activate prematurely if the blue safety release is removed using a sideways force. This can happen if a user tries to hold the device with only one hand and tries to remove the safety release with his or her thumb using lateral force.

Before using the device, the blue safety release should be removed by pulling straight up with one hand and holding the device with the other hand, the companies advise.

In addition, they say a "very limited number" of EpiPen devices may have a blue safety release that is slightly raised, which may cause the device to activate prematurely, potentially delaying or preventing emergency treatment when needed.

To prevent this from happening, pharmacists, patients, and their caregivers should check to make sure the blue safety release is not raised; if it is raised, the auto-injector should not be dispensed or used.

Carrier Tube and User Problems

Another problem is that some EpiPen devices may not slide out of the carrier tube easily, or at all, because of a slight deformation on the rim of the carrier tube. When this happens, the user may not be able to quickly remove the auto-injector from the carrier tube.

This issue may affect any EpiPen auto-injector lot currently on the market in the US with an expiration date prior to September 2020. However, the likelihood of an auto-injector having this is "very low," the companies say. 

To be sure the device can be used when needed, pharmacists, patients, and caregivers should test that they can remove the device. Specifically, they should remove both carrier tubes from the S-clip, flip open the caps of the carrier tubes, and tip each carrier tube to make sure each auto-injector slides out easily.

Auto-injectors that do not easily slide from their carrier tubes should not be dispensed or used. Providers may contact Mylan customer relations at 1-800-796-9526 to obtain replacement devices at no additional cost.

Through research, the companies have also identified several potential user errors that may delay or prevent delivery of an intended dose of epinephrine. They include:

  • Failing to remove the device from the carrier tube prior to use

  • Failing to remove the blue safety release prior to use

  • Activating the auto-injector upside down

  • Failing to apply sufficient force to activate the device

  • Administering a dose at a site other than the outer thigh

  • Failing to hold the auto-injector in place for at least 3 seconds

"It is important for healthcare 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," the FDA says.

Quality problems or adverse reactions with epinephrine auto-injectors should be reported to the FDA's MedWatch program.

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