Breaking News – EpiPen Malfunction

anaphylaxis epipen
Suzanne B. Robotti
Suzanne B. Robotti Executive Director

Just released from the FDA – Pfizer has informed the FDA that they are aware of several continuing problems that people are having using the EpiPen (epinephrine) and EpiPen Jr (epinephrine) auto-injectors and generic versions. Some of the problems are from user error and some from EpiPen malfunction.

Here are the common problems that are causing delayed or improper injections:

  1. These auto-injector pens may activate prematurely if the blue safety release is removed using a sideways 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. Two hands are needed to release the blue safety knob correctly: 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.
  2. A limited number of EpiPens 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.
  3. 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.

Here are specific user errors that can delay or prevent the administration of the intended dose of epinephrine. For example:

  • The device will not activate if the blue safety release is in place
  • Ensure the needle end (orange end of the device) is in contact with the outer thigh (upper leg) prior to and during activation. The EpiPen device should be administered by swinging and pushing firmly against the outer thigh until it “clicks.” This signals that injection has started.
  • Ensure the device is held in place for a minimum of three seconds following activation

Pfizer recommends that patients review the instructions for correct self-injection periodically with a health-care provider.

If you have a problem with your auto-injector (generic or brand name) 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.