Because some auto-injector users have experienced lacerations, bent, or embedded needles, or infections at injection sites the FDA has revised instructions for auto-injector (AI) use. No alterations are being made to AI devices; the updated instructions are for increased patient safety only. Since 2006, 26 cases of minor injury owed to AI use have been reported, most involving young children obtaining thigh lacerations while being treated for an allergy reaction with a Mylan EpiPen*.

Less Time, Less Movement

The AI injuries have largely occurred when young patients moved or kicked while receiving an injection. To minimize this risk, the revised AI instructions will tell users to:

  • Hold the patient’s leg firmly in place, and limit their movement before and during administration.
  • Hold the auto-injector firmly in place for 3 seconds (count slowly 1-2-3).

Although Mylan AI users have been instructed to hold their devices in place for ten seconds to ensure epinephrine delivery, tests show a full dose is actually delivered in three seconds or less. A three-second administration time will make AI treatment easier for all users, but especially for the young and restless, and should eliminate the injuries that occurred when care-givers re-injected an AI following a premature withdrawal of the needle.

Addressing Infection

Another AI instruction update is that patients should get medical care if they notice any signs of infection at an injection site. Though rare, there have been cases of serious skin and soft tissue infection at auto-injection sites, some caused by Clostridia, or gas gangrene. Using alcohol wipes can diminish the presence of skin bacteria, but will not get rid of Clostridium spores. Any AI user who notices persistent swelling, warmth, redness, or tenderness at an injection site should see a medical professional.

Mylan is now updating their training and support materials to incorporate the revised patient instructions and will be educating the medical community about these changes.

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