FDA warns of defective EpiPen dangers

FDA warns of defective EpiPen dangers

(HealthDay)—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 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 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 , 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.


Explore further

Defect prompts Mylan to recall some Epipens

More information: More Information

Copyright © 2020 HealthDay. All rights reserved.

Citation: FDA warns of defective EpiPen dangers (2020, March 26) retrieved 28 March 2020 from https://medicalxpress.com/news/2020-03-fda-defective-epipen-dangers.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
1 shares

Feedback to editors

User comments