When you take an emergency puff of your asthma inhaler, inject yourself or your child with epinephrine for a severe allergic reaction, or rub ointment on your skin to treat eczema, you want the medication to be safe and fully effective.

Image of man injecting an epi-pen into this thigh through his trousersTaking medication that is expired presents a significant risk – and asthma and life-threatening allergies (anaphylaxis) are not conditions to take lightly.

A recent news report suggests that medication in epinephrine auto-injectors lasts beyond their expiration date. A study published in the Annals of Internal Medicine last month found that epinephrine auto-injectors retained at least 84 percent of their medication concentration four years after expiration.

While taking an expired epinephrine auto-injector to treat a severe allergic reaction is better than taking no epinephrine at all, doctors maintain it’s critically important that patients refill their epinephrine auto-injector prescription when it’s expired.

According to the Food and Drug Administration (FDA), which sets expiration dates for U.S. medications and posts them on product labels, “Once the expiration date has passed, there is no guarantee that the medicine will be safe and effective.”

Expired medical products can become less effective due to changes in chemical composition or a decrease in strength, FDA says.

Knowing when your asthma or allergy medications expire is an important part of managing your condition. Care should be taken to refill a prescription for an epinephrine auto-injector on or before the expiration date given the life-threatening nature of anaphylaxis.

For epinephrine, it’s important to store and maintain the device correctly. The chemical is inherently unstable and degrades rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.

EpiPen® product labels advise the following: “Protect from light. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. Store at 68 to 77 degrees Fahrenheit; excursions permitted to 59 to 86 degrees Fahrenheit. Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace your auto-injector if the solution is discolored (pink or brown), cloudy or contains particles.”

Quick Tips

  • The shelf life of a medical product is based on review of several product attributes compared against FDA-approved specifications. If any of these product attributes fall outside of the FDA-defined specifications during development, then the shelf life is limited to the timeframe which all attributes are assured to be within the required specifications.
  • FDA provides the expiration dates and information on storage and handling for all U.S. prescription drugs, including epinephrine, on the approved product label.
  • The FDA website states, “Once the expiration date [of a medication] has passed, there is no guarantee that the medicine will be safe and effective.”