EpiPens still effective past expiration date, new study finds
People in the midst of a severe allergic reaction shouldn’t hesitate to use an expired EpiPen if that’s all they have, a new study indicates.
According to a research letter published in the Annals of Internal Medicine this week, the auto-injectors retained much of their potency well after the expiration date. EpiPens have a shelf life of 18 months, but that includes the time it takes to distribute the product, so patients typically must replace them annually.
The study analyzed 40 expired pens collected over two weeks at a clinic in San Diego from patients and health care providers.
It found that 29 months after expiration, the pens contained at least 90 percent of the original epinephrine used to stop the life-threatening allergic reaction called anaphylaxis. The concentration was still at 84 percent after 50 months, or some four years, past the expiration.
“That would fall within the recommended therapeutic range for epinephrine if someone was having a life-threatening allergic reaction,” said Lee Cantrell, a pharmacist, professor and director of the California Poison Control System in San Diego, whose team did the analysis.
Mr. Cantrell said he decided to conduct the study because of last summer’s public outcry over the soaring price of the EpiPen, which is sold by generic drug giant Mylan.
People who could no longer afford to replace their pens — which skyrocketed some 500 percent in recent years to more than $600 a two-pack — were calling the poison control center asking whether they would get sick using expired pens, he said.
Despite his findings, Mr. Cantrell said he wasn’t telling people to stop refilling their EpiPens on time.
“But if someone is having an acute reaction, it’s better to use an expired EpiPen — as long as it is not discolored — than no EpiPen at all,” he said. “I’ve never seen a reported case of anyone getting sick from using an expired EpiPen.”
If the medication, which can be seen through a little window on the device, is not clear, “The manufacturer says you shouldn’t use it,” he said.
Mr. Cantrell said that five years ago he analyzed various medications that had been expired for at least 40 years. “The vast majority retained their full potency.”
He said he wasn’t advocating that people routinely take expired medications, but said further study was needed.
“In my personal opinion, there is a clear need to revisit our practices for medication expiration dates in the U.S.”
Mylan, which is run from executive offices in Cecil, did not return emails seeking comment.
In an email to Reuters, a Mylan spokeswoman said EpiPen expiration dates reflect “the final day, based on quality control tests, that the product has been determined to be safe and effective” when stored properly. She said patients were encouraged to refill their prescriptions upon expiration.