FDA Warns of Defective EpiPen Dangers
Devices may activate prematurely if the blue safety release is removed using sideways force
WEDNESDAY, March 25, 2020 (HealthDay News) -- Certain types of EpiPens and their generic counterparts may fail or delay injection of lifesaving epinephrine for severe allergic reactions, the U.S. Food and Drug Administration warns.
Problems may occur in EpiPen 0.3 mg and EpiPen Jr 0.15 mg autoinjectors and authorized generic versions due to device malfunctions and user errors, according to the agency. The devices may activate prematurely if the blue safety release is removed using sideways force, the FDA said. For example, a person may hold a device with one hand and try to remove the safety release with their thumb. Before use, the device should be held in one hand and the safety release should be removed by pulling straight up with the other hand.
Some EpiPen devices also may have a blue safety release that is slightly raised, the FDA said. If that is the case, the device may activate prematurely, which could delay or prevent emergency use. In addition, some EpiPen devices may not slide out of their carrier tube easily or at all due to a slight deformity on the tube's rim, the FDA said.
"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 autoinjector," the FDA said in an agency news release. The FDA called on pharmacists to inspect the devices before dispensing them to patients. It advised patients who have an issue with their autoinjector to contact EpiPen manufacturer Mylan at 800-796-9526 to get a replacement at no additional cost.