Label Causing Delay in Accessing Epinephrine for Some EpiPen Users

The FDA has issued a warning to patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, as well as authorized generic versions, may block access to the auto-injector. Although there is no issue with the auto-injector device or the epinephrine it delivers, a misapplied label may prevent the drug from being quickly accessed.

In a letter to health care professionals from Pfizer, the manufacturer of the Mylan EpiPen, the company indicates that the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube, the package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube.

The auto-injector device and epinephrine can be used as prescribed. These lifesaving products are designed for an emergency situation, and patients and caregivers should inspect their EpiPen devices prior to needing it to ensure they can quickly access the product.

The letter also describes how to inspect potentially affected products and explains that patients should contact MylanCustomer Relations at 800-796-9526 if an auto-injector does not slide out easily from the carrier tube or the label is not fully adhered to the auto-injector. Pharmacists should inspect the products before dispensing them to patients to ensure quick access to the auto-injector and should not dispense any product which does not easily slide out of its carrier tube.

The FDA is not aware of any adverse event reports associated with improperly applied EpiPen or EpiPen Jr auto-injectors, or their authorized generics label. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.

Reference

FDA alerts patients and health care professionals that some EpiPen auto-injectors may not readily slide out of carrier tube [news release]. Silver Spring, MD; November 2, 2018: FDA website. https://www.fda.gov/Drugs/DrugSafety/ucm624986.htm?utm_campaign=FDA%20alerts%20patients%20and%20health%20care%20professionals%20EpiPen%20auto%20injector%20carrier%20tube&utm_medium=email&utm_source=Eloqua. Accessed November 2, 2018.