Expired Epinephrine Can Still Save Lives

Epinephrine is the only treatment that can reverse the life-threatening symptoms of anaphylaxis, a severe allergic reaction. Spring-loaded syringes called auto-injectors make it easier for patients, health care providers and members of the public to inject the correct dose of epinephrine solution into the patient’s thigh muscle.

Since May 2018, U.S. Food and Drug Administration (FDA) has reported shortages of two of the three types of epinephrine auto-injectors currently sold on the U.S. market. This month, FDA has taken two steps to remedy this shortage and minimize its impacts.

  • On Aug. 16, FDA announced the approval of a fourth auto-injector, a generic version of the EpiPen® made by Teva Pharmaceuticals. While this action is expected to make epinephrine auto-injectors more accessible and affordable in the future, the Teva Pharmaceuticals auto-injector will not reach consumers in time for back-to-school purchases.
  • On Aug. 21, FDA extended by four months the expiration dates for specific lots of EpiPen marketed by Mylan Specialty. This decision was based on stability data provided by Mylan and reviewed by FDA.

As some families struggle to replace old auto-injectors with new ones in time for school, the shortage has drawn attention to epinephrine’s short shelf life and raised the question of whether expired epinephrine auto-injectors not covered by the Aug. 21 FDA extension remain safe to use. During the auto-injector shortage, FARE recommends that FDA notify the public – including schools – that expired epinephrine can still potentially save lives.

When Is Outdated Epinephrine Useful, and When Is It Not?

Epinephrine raises the heart rate and opens blood vessels and airways to improve blood flow and breathing. Since the drug must travel through the blood stream to work, treatment with epinephrine can become less effective as blood circulation becomes more impaired. When epinephrine is needed, an in-date (unexpired) auto-injector that has been stored out of direct light and at room temperature is the best option. If an in-date auto-injector is not available, it is better to use an expired auto-injector than to not give epinephrine.

There’s an important exception to this recommendation: epinephrine should not be used if it is pinkish, is more than slightly yellow, is cloudy or contains particles. Regularly check the auto-injector’s viewing window (if it has one) to see if your epinephrine is showing these signs of decay.

How Long Can I Rely on My Outdated Auto-Injectors?

Epinephrine is less chemically stable than most medications. A 2006 article about a U.S. Department of Defense (DoD) program to extend the useful life of stockpiled drugs reported that, while most properly stored epinephrine remained at full strength one year after the expiration date, some epinephrine did not. The same DoD program found that albuterol inhalers are less likely than epinephrine to remain effective a year past the expiration date. Asthma – especially asthma that is poorly controlled – increases the risk of a fatal or near-fatal food allergy reaction, so patients should also check the expiration date on their rescue inhalers.

FARE’s medical advisors believe that properly stored epinephrine auto-injectors should be safe and effective to use up to nine months after the expiration date. Extending auto-injector use by nine months matches the FDA guidance on the extended use of pre-filled epinephrine syringes, which are also in short supply. For more information about epinephrine stability, the references below summarize some small studies of expired auto-injectors.

Given the risks of delaying epinephrine to treat severe reactions, FARE encourages FDA to communicate clearly to schools that expired undesignated (stock) epinephrine auto-injectors should not be discarded until they can be replaced with new ones. Moreover, schools should allow students to carry or store their prescribed auto-injectors past the expiration date until in-date auto-injectors become available. FARE believes that no one at risk for anaphylaxis should be without this lifesaving medication because they cannot access or afford it.

To find out whether FDA has extended the expiration of your 0.3 mg EpiPen or Mylan generic of the 0.3 mg EpiPen, check the batch numbers listed on the FDA website. For steps you can take to find new auto-injectors during the shortage, visit the epinephrine shortage page on foodallergy.org.

Additional References

Simons FE, Gu X, Simons KJ. Outdated EpiPen and EpiPen Jr autoinjectors: past their prime? J Allergy Clin Immunol. 2000 May;105(5):1025-30.

In a Canadian study, 34 EpiPen®and EpiPen Jr®auto-injectors collected from patients were tested at one month to 7.5 years after the expiration date. All 34 still contained more than half of the labeled dose, but two were darkly discolored and therefore unusable. Of the 16 outdated auto-injectors tested within 25 months of the expiration date, 5 contained a full dose (that is, at least 90 percent of the labeled dose).

Rachid O, Simons FE, Wein MB, Rawas-Qalaji M, Simons KJ. Epinephrine doses contained in outdated epinephrine auto-injectors collected in a Florida allergy practice. Ann Allergy Asthma Immunol. 2015; 114(4):354-356.e1.

A Florida allergy practice collected EpiPens that were three months to three years past the expiration date. Roughly half showed very slight discoloration. All 35 auto-injectors contained at least 84 percent of the full, labeled dose of epinephrine, and every auto-injector expired for two years or less contained a full dose.

Cantrell FL, Cantrell P, Wen A, Gerona R. Epinephrine Concentrations in EpiPens After the Expiration Date. Ann Intern Med. 2017; 166(12):918-919.

Forty EpiPen and EpiPen Jr auto-injectors that had been expired for 1 to 50 months were tested. All 40 auto-injectors contained more than 80 percent of the labeled dose. About two-thirds of the auto-injectors – including 22 of the 24 auto-injectors expired for 25 months or less – contained a full dose.

For more information on anaphylaxis and epinephrine, please visit foodallergy.org/anaphylaxis.

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