29 months after expiring, tested EpiPens contained at least 90% of the stated amount of epinephrine
"Essentially, all of these would still be in the recommended therapeutic range," expert says
"Expiration date is the final day ... that a product has been determined to be safe and effective," company says
EpiPen products can still deliver an effective dose long after they have expired, according to a study published Monday.
The active ingredient in auto-injectors like the EpiPen is epinephrine, more commonly known as adrenaline, a hormone that can help relax muscles. It can open airways and reduce swelling during a severe allergic reaction.
The price of the auto-injection devices has gone up 400% since 2007, drawing the ire of patients who rely on them to quickly counter life-threatening reactions. Outrage grew as more insurance providers dropped coverage of the EpiPen.
Amid the criticism, manufacturer Mylan developed a cheaper generic alternative priced at $300 for two pens.
With these patients in mind, researchers tested devices whose expiration dates had passed to determine whether they were still potent and safe.
Study author Lee Cantrell, professor of medicine and pharmacy at the University of California, San Diego, and his team measured the epinephrine concentration of 40 expired EpiPens and EpiPen Jrs. They found that 29 months after expiration, the pens contained at least 90% of their stated amount of epinephrine. Pens 50 months – more than four years – past the printed expiration date had more than 84% of the medication.
“Essentially, all of these would still be in the recommended therapeutic range,” said Dr. Thomas Casale, a professor of medicine at the University of South Florida and executive vice president of the American Academy of Allergy, Asthma, and Immunology.
The new study builds on previous research finding that epinephrine auto-injectors have a much longer shelf life than labels said. A 2015 study found that some retained more than 90% of their stated dose two years after expiring.
Despite the findings, Casale, who was not involved in the new study, said patients probably won’t want to take a chance with a potentially life-saving medication.
“Until those labels are changed, patients are in a bad situation, because they’re concerned about having a life-threatening event and not having a medicine that’s effective,” he said.
Both Cantrell and Casale say that if someone has an allergic reaction, expired epinephrine is better than nothing at all.
“Our paper is not suggesting that people take expired medication,” Cantrell said. “We can’t make that leap based on our data. But what we can say is that if you have nothing else, and you’re having a life-threatening reaction, certainly use the expired epinephrine.”