March 24, 2020

The U.S. FDA has issued a safety communication advising users of Mylan’s EpiPen® (epinephrine 0.3mg) and EpiPen Jr® (epinephrine 0.15mg), as well as the authorized generics, of a risk of delayed or improper injection. Epinephrine for injection is indicated to provide emergency treatment of allergic reactions, including potentially life-threatening anaphylaxis.

The agency reports that these problems may be caused by:

  • Device failure due to spontaneous activation, caused by using sideways force to remove the blue safety release.
  • Device failure from inadvertent or spontaneous activation due to a raised blue safety release.
  • Difficulty removing the device from the carrier tube.
  • User error.

A letter from the manufacturer to healthcare professionals detailed the nature of these issues. For instance, sideways force can occur when a user tries to hold the autoinjector and remove the safety release with only one hand, using their thumb to remove the release. Ideally, individuals should use two hands – one to hold the device, and the other to pull straight up on the release to remove it.

A limited number of devices may have a slightly raised release, which can cause premature activation, delaying or preventing the delivery of emergency treatment via epinephrine injection. It is also possible for there to be a deformation on the rim of the devices’ carrier tubes, which can make it difficult or impossible to remove the autoinjectors from the tubes.

User errors can include failure to remove the blue safety release, failure to ensure the needle end of the device is in contact with the outer thigh prior to and during activation, and failure to hold the device in place for at least three seconds following activation. According to the manufacturer, the autoinjector should be used by swinging and pushing firmly against the outer thigh until it clicks to signal that injection has started.

Patients and caregivers should undergo periodic review of proper EpiPen use with a healthcare professional. They should also inspect epinephrine autoinjectors prior to needing them for any issues that may interfere with proper administration. If there is an issue with the autoinjector or its carrier tube, consumers can contact Mylan Customer Relations at 1-800-796-9526 to obtain a replacement at no additional cost. It’s also recommended that pharmacists inspect the products before dispensing them and not dispense any autoinjectors that do not slide easily out of their carrier tubes or that have a raised blue safety release.

The FDA’s full safety communication can be viewed at the agency’s website.

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