(RxWiki News) The US Food and Drug Administration (FDA) issued an alert regarding possible malfunctions with a common severe allergy injection.
The alert is for EpiPen auto-injectors, including EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors and their authorized generics.
This injection is approved to be given for allergic emergencies (anaphylaxis).
The FDA notified both patients and health care providers about the possibility of problems due to both device malfunctions and user error.
These malfunctions and user errors can delay the injection or prevent the device from properly injecting. As a result, the person may not receive the treatment they need.
The four factors that can lead to an error are as follows:
- Device failure: This can happen if the blue safety release is removed using a sideways force. An example is if the user holds the device with one hand and attempts to remove the blue safety release with their thumb (in a sideways force). The correct way is to use both hands to handle the device to remove the blue safety release. Before use, the blue safety release should be removed by pulling straight up with one hand and holding the device with the other hand.
- Device failure: A raised blue safety release can lead to a delay in treatment or prevent the person from getting the medication they need.
- Deformation: There may be an issue with the rim of the carrier tube, which can make it difficult to quickly remove the device.
- User error: These errors can delay or prevent the administration of the right dose. To ensure proper injection, users must make sure:
- To remove the blue safety release as instructed. If the blue safety release is in place, the device will not inject the medication.
- The needle (orange end of the device) is in contact with the outer thigh. The user must hear a "click." This sound signals that the injection has started.
- To hold the injection for at least three seconds.
Make sure you understand how to use this injection. Even if you have been taught already, it may be a good idea to go through the instructions and practice with the EpiPen trainer periodically with your health care provider.
The FDA said parents should inspect the injections ahead of time. Based on some the possibilities listed above, the agency recommended making sure the blue safety release is not raised and the device can be easily and quickly removed from the tube it comes in.
If you find an issue with your auto-injector, contact Mylan Customer Relations at 800-796-9526. You may be able to get a replacement at no additional cost.
Speak with your health care provider if you have any questions.