The epinephrine in auto-injectors appears to have a longer shelf life than the expiration date indicates, a California study finds.
Lee Cantrell, a professor of medicine and pharmacy at the University of California, San Diego, and his team collected 40 expired EpiPens and EpiPen Jrs. over a two-week period to determine if the medicine inside the device can retain its potency.
The researchers found range of effectiveness, including:
- Nineteen devices that were 29 months past their expiration date contained at least 90 percent of the stated amount of epinephrine.
- Two EpiPens that were 50 months past expiration retained 84 and 88 percent of the medication.
- Three EpiPen Jrs. that were 30 months expired contained up to 88 percent of the stated epinephrine.
There has been considerable controversy over the price of a set of two EpiPen auto-injectors, which has jumped an estimated 500 percent (to about $600) since 2007. The sudden increase has led a lot of people to ask their doctors if expired EpiPens are OK to use because they could not afford replacements. “My wife, who worked on the study as well, is a pediatrician and gets the question a lot,” Cantrell told Allergic Living.
Commenting on the study, Dr. Thomas Casale, executive vice president at American Academy of Allergy Asthma and Immunology (AAAAI), said by email: “We would still recommend that patients refill their epinephrine according to the expiration date listed. However, if they do not have a new auto-injector and only an expired auto-injector, it is better to use that than nothing, as the medication may still be good.”
In October 2016, Mylan, which markets the EpiPen, told Allergic Living that it would be submitting a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking to lengthen the shelf life of EpiPen auto-injectors to 24 months (from 18 months). Julie Knell, Mylan’s senior director of communications, confirmed the company has now filed that application for a “new formulation that will extend the product shelf life.” She said the company hopes to offer a device with a 24-month shelf life within a year.
Until the FDA responds to the application, Mylan encourages patients to refill their auto-injectors upon expiration. “An expiration date is the final day, based on performed quality control tests, that a product has been determined to be safe and effective when stored under the conditions stated in the package insert,” says Knell.
Cantrell as well is not advocating using expired epinephrine, but says his team’s findings, published in the Annals of Internal Medicine, suggest that the process of determining the expiration date of medication needs to be revisited and potentially revised in the United States.
“I think the biggest message you can get from this study is that it’s probably safe to say many medications retain full potency well beyond their expiration date,” he said.
The FDA has issued statements in past warning people against using expired medication as a general rule.
If you do choose to use expired epinephrine, Cantrell cautions to check for discoloration in the auto-injector’s window panel.
“If expired epinephrine is the only alternative, and you or a loved one is having a potentially life-threatening reaction, I’d look to see if it was discolored. If it wasn’t, I’d use it.”
He says discoloration doesn’t indicate epinephrine would be harmful, but rather that it’s lost its potency. Two previous small studies have also indicated the potential longer shelf life of epinephrine.