Study reveals EpiPens stay effective years after expiration date

pharmafile | May 10, 2017 | News story | Research and Development EpiPen expiration, Mylan, Mylan scandal, epipen 

The Annals of Internal Medicine has published a study that indicated that EpiPen injectors retain a medically significant proportion of its active ingredient, epinephrine, after their expiration date. The researchers took a selection of EpinPens and EpiPen Juniors to determine how rapidly the medical devices lost efficacy, finding that the EpiPens retained enough active ingredient to be medically effective four years after their expiry date.

The study was undertaken after it openly acknowledged that: “Interest and outrage have been mounting over dramatic price increases for the emergency-use epinephrine autoinjection device EpiPen”. For those that remain unaware, the price of EpiPens has risen from $100, in 2008, to the current price of $600.

The price increases led to serious questions of Mylan, the producer of the injector, and its pricing practises. It spurred Mylan to release a cheaper generic version of the product but the damage done to its reputation is here to stay, especially as studies, such as this, continue to emerge.

During their research, the scientists discovered that EpiPens retain 90% of the medication up to 29 months after their official expiration date and 84% at 50 months after. The potency standard is 90% and above – meaning that well over two years after the expiration date, the product would still be above standard for use.

The expiration dates on EpiPens are 18 months after their production but, as they often take 6 months to reach pharmacists, this means that they have a shelf-life with patients for only 1 year.

Those responsible for the study are not suggesting ignoring expiration dates on the injectors but, speaking to Reuters, the lead author of the study, F. Lee Cantrell, suggested: “If my kid’s having a life-threatening reaction, and I had no alternative, absolutely I would use it without hesitation…I don’t think there’s a physician in the world who would rebut that.”

The problem comes when families, who are not covered by insurance, and have to pay large proportion of the cost of the medication, have to make decision about where to spend their money. Many will already be deciding whether the money would be better spent on rent or food, and this research could suggest that keeping hold of older injectors could still be good idea.

Ben Hargreaves

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