March 25, 2020
2 min read

FDA issues alert about EpiPens

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The FDA issued an alert about EpiPen 0.3 mg auto-injectors, EpiPen Jr. 0.15 mg auto-injectors and authorized generic versions, stating that these products may have delayed or incorrect injections that could cause injury or death.

A spokesperson for Pfizer, manufacturer of EpiPen (epinephrine), told Healio Primary Care that a “very limited number of cases” prompted the alert.

Pfizer and Mylan, distributor of EpiPen, stated in a letter sent to health care professionals that cases were caused by patients using sideways force to remove the devices’ blue safety release, causing spontaneous activation; “device failure” from raised blue safety releases that led to inadvertent or spontaneous activation; a “slight deformation” on the rim of some carrier tubes that made it difficult for patients to remove the device; and user errors, such as failing to remove the device from the carrier tube or blue safety release before use, turning on the auto-injector upside down, not applying enough force to activate the device, administering treatment at the wrong site, and failing to hold the device in place for 3 seconds.

The companies added that depending on the error, patients may experience a delay or prevention of emergency treatment of epinephrine, accidental puncture of their hand — which could lead to infection, anaphylactic shock or death — and incomplete treatment or bone strike — which could also lead to infection or nerve injury — if administered somewhere other than the outer thigh.

“The information gathered serves as an important opportunity to provide precautionary handling instructions and remind the severe allergy community about the correct administration of EpiPen and recommendation to carry two EpiPen or EpiPen Jr. auto-injectors or the authorized generic version at all times,” the Pfizer spokesperson said.

The companies’ letter to health care professionals also stated: “To ensure the device can be used when needed, pharmacists, patients and their caregivers should be advised [to] remove both carrier tubes from the S-clip, flip open the caps of the carrier tubes and tip each carrier tube to verify that each auto-injector readily slides out of the tube. If the auto-injectors do not readily slide from the carrier tubes, they should not be dispensed or used.”

According to the companies’ letter, patients “should continue to carry their EpiPen or EpiPen Jr. or authorized generic version at all times.” Patients whofind issues with their auto-injector can contact Mylan at 800-796-9526 and receive a free replacement. – by Janel Miller