EpiPens could fail when allergy sufferers need them, FDA warns

by Paula A. Wyatt | April 17, 2020 | Blog, Product Liability | 0 comments

EpiPens could fail when allergy sufferers need them, FDA warns The U.S. Food and Drug Administration (FDA) is warning that some EpiPens or their generic versions could fail to provide the lifesaving dose of epinephrine that people rely on in the case of a severe allergic reaction. The auto-injectors on some of the EpiPen 0.3 mg and EpiPen Jr 0.15 mg, and some of the generic counterparts have malfunctioned, the FDA said. The auto-injectors have a blue safety release that can be activated prematurely if it is released while the pen is sideways. For example, the user could be holding the EpiPen in one hand while trying to discharge the safety release, and the medicine could eject. The FDA suggests the use of both hands. The user should hold the EpiPen in one hand, straight, while pulling the blue release straight up with the other hand. Additionally, the blue safety tab could be slightly raised on some EpiPens. In that instance, the pen could prematurely activate, and that could either delay or prevent the use from getting the needed dose. The FDA also cautioned that the some EpiPens might be stuck in the tube they come in because of a problem with the tube’s rim. The agency advised pharmacists to inspect the pens before they are dispensed to the patients and said users should be sure to know the proper way to use them. "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 auto-injector," the FDA said in a news release. EpiPens commonly are used in instances of allergic reactions to bee stings or peanuts. Allergy sufferers rely on this medication for emergency use and need the comfort of knowing they don’t have a defective product when they need it the most.


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