Published September 19, 2012 (revised December 23, 2024)
If you keep an EpiPen (epinephrine) on hand to treat a severe allergic reaction, you need to know about a potentially dangerous mix-up between the actual EpiPen pen and a similar-looking training pen.
EpiPen is an "auto-injector" that looks like a pen but contains the medicine epinephrine and has a needle at one end. When injected immediately for emergency treatment of a severe allergic reaction, epinephrine can be lifesaving. EpiPen Jr contains a lower dose of epinephrine and is used for children. The EpiPen Jr. for children has a lower epinephrine dose than the one for adults.
EpiPen and EpiPen Jr are sold in packages with two active pens and one training pen (Figure 1). The manufacturer of the EpiPen and EpiPen Jr package both products with two actual pens because severe reactions often require two injections. The training pen is similar to the active pen in size, shape and colors, but it does not contain a needle or medicine. The purpose of the training pen is to allow people and/or caregivers to practice the special method needed to properly administer an injection with the EpiPen: First you remove the blue safety-lock cap. Then you press the orange end of the pen very firmly against the designated area of a leg. That pressure causes the needle to pop out and automatically inject the drug. You must hold the pen in place for approximately 10 seconds, so that the entire dose is injected.
Unfortunately, the training pen and active pens are so similar looking that they are easily confused, even though a label on the training pen states, “Training Device” (Figure2).
Mistakenly using the training pen in an emergency would be dangerous. Even without a needle, pressing the training pen hard against the leg may feel the same as an actual injection. Therefore, the person having the allergic reaction could mistakenly think they actually got the epinephrine injection. If the error is not quickly recognized, the person’s symptoms would continue to get worse and could become life-threatening.
We have notified the US Food and Drug Administration (FDA) about the concern and have also contacted the company on two occasions to request them to provide EpiPens as a single unit, with the training device packaged separately. They insist on keeping the devices together in the same packaging.
Here's what you can do: To prevent mix-ups between the active EpiPen and the training device, follow these recommendations.