Epinephrine oxidizes into ADRENOCHROME
Why EpiPens expire so quickly
Why EpiPens expire so quickly
By Carolyn Y. Johnson
September 27, 2016
Heather Bresch, chief executive of Mylan, holds up EpiPen medication while speaking at a House Oversight and Government Reform Committee on Sept. 15. (Andrew Harrer/Bloomberg News)
Mylan chief executive Heather Bresch said one thing at a contentious hearing last week that should be music to the ears of people with life-threatening allergies: Her company will soon push to extend the shelf life for EpiPen.
Currently, EpiPens expire 18 months from date of manufacturing. Facing criticism for the drug's rapidly rising price, Bresch said the company hopes the expiration date can be extended to a minimum of 24 months.
To make the case, Mylan will need to convince regulators that their data demonstrates that a new EpiPen formulation can remain effective for months longer.
"We hope, within the next 12 months, we will have approved a new formulation that will extend the shelf life," Bresch said during Thursday's hearing.
[Mylan’s EpiPen profits are 60 percent higher than it told Congress]
An extension would increase the time between refills and help quell a common complaint among patients and parents who have to toss out unused EpiPens annually and buy new ones. There's a common misconception that EpiPen's shelf-life is just a year, because time elapses between the manufacturing of the drug and when people pick up their prescriptions.
This wouldn't be the first time EpiPen's expiration date was altered. In 2002, the shelf life was 27 months, but a formulation change by the then-owner Meridian Medical Technologies required a shorter expiration date, said Theresa Eisenman, a spokeswoman for the Food and Drug Administration. Initially, the approval was for 20 months, but subsequent data supported 19 months. The company decided to use 18 months, she said.
EpiPens are, fortunately, needed only in emergencies. Discarding them unused on a regular basis can feel wasteful, particularly when the price tag has gone up to more than $600 for a pack of two – but it's also critical that they work, exactly as designed, when they are needed. Doctors say questions about the expiration date of the product come up all the time.
The origins of EpiPen's expiration date
EpiPen's shelf life has been limited by the chemistry of the drug inside it. Epinephrine is an old and cheap medication, but it's also notoriously finicky. If exposed to light, heat or air, it can degrade, turning rust colored.
The FDA-approved label warns that if the liquid in the pen is discolored, it should be discarded: "Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
But what about an expired EpiPen that looks perfectly normal?
The little published data that exists shows that the drug degrades over time – and color is not an accurate way to gauge whether the epinephrine inside is still good.
Sauce: https://www.washingtonpost.com/news/wonk/wp/2016/09/27/why-epipens-expire-so-quickly/?noredirect=on