EpiPen May Retain Potency up to Four Years After Expiration Date

While pharmaceutical company Mylan recommends patients replace their EpiPens each year, a new study suggests that the active ingredient inside the medical device could still be potent up to four years after the expiry date. The team of researchers from the University of California in San Diego, published their findings in the journal, Annals of Internal Medicine.

Mylan has faced increasing scrutiny over the past year in relation to their drug pricing practices. The company has increased the price of their EpiPen autoinjectors by almost 450 percent over the past decade.

Concerned that the rising costs may make it hard for those with severe allergies to afford replacement autoinjectors each year, Dr. Lee Cantrell, a professor of medicine and pharmacy at the University of California, San Diego, set out to determine whether the epinephrine inside the autoinjectors would still be potent even after the printed expiry date.

Over a two-week period, the study investigators collected unused, expired EpiPens from patients at a medical clinic. Cantrell and his team then used liquid chromatography–tandem mass spectrometry to quantify the epinephrine concentration in the medical devices.

While the drug did show lower potency after the expiry date, the EpiPens retained 84 percent of the original concentration of epinephrine after 50 months post-expiry. According to the researchers, this potency level is sufficient to treat a patient with severe allergies who goes into anaphylactic shock.

The EpiPen Jr – a device used to treat pediatric patients – showed the lowest potency of 81 percent epinephrine after the expiry date had passed. Based on these findings, Cantrell and his team are urging Mylan and pharmaceutical regulators like the FDA, to extend the life span of these lifesaving devices.

“Our paper is not suggesting that people take expired medication,” said Cantrell in an interview with CNN . “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.”

While patients with severe allergies must carry an EpiPen with them at all times in the event that they experience a life-threatening allergic reaction, many patients will never need to use the medical device. Recent cost increases have prompted some patients to avoid filling their prescription to get a new EpiPen on an annual basis.