Forty EpiPen and EpiPen Jr auto-injectors that had been expired for 1 to 50 months were tested. All 40 auto-injectors contained more than 80 percent of the labeled dose
Probably true but needs proof. They need to test and re-certify the existing devices for higher and lower temperatures, but they had no incentive to do so before there was competition. Hopefully this will be the swift kick in the butt they need.
There's little point in re-certifying, because if the pens only contain 80% of the dose in these conditions, they will almost certainly fail the certification in those conditions. They presumably contain the dose they do to ensure that device is as safe as possible - so that it's high enough that it can save the patient in almost every case but low enough to not cause other issues or side-effects.
What that third-party test shows is that if all you have available is a supposedly 4-year past-expiry pen and it's been kept at all the wrong temperatures, you should probably still use it in an emergency because there's a good chance it will still work. Not a big enough chance that they recommend using expired pens, but enough that if the choice is probably dying or using it, you absolutely should use it.
Of course you should try an expired EpiPen if that's all you have during an emergency. But that doesn't mean you should ignore the storage temperature requirements for EpiPens, even if they are currently a bit conservative, and Neffy's better performance in high temperatures is a huge advantage.
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As a practical matter epi-pens work just fine outside spec. Heat just speeds up the degradation. Also see https://www.foodallergy.org/fare-blog/expired-epinephrine-ca...
Probably true but needs proof. They need to test and re-certify the existing devices for higher and lower temperatures, but they had no incentive to do so before there was competition. Hopefully this will be the swift kick in the butt they need.
There's little point in re-certifying, because if the pens only contain 80% of the dose in these conditions, they will almost certainly fail the certification in those conditions. They presumably contain the dose they do to ensure that device is as safe as possible - so that it's high enough that it can save the patient in almost every case but low enough to not cause other issues or side-effects.
What that third-party test shows is that if all you have available is a supposedly 4-year past-expiry pen and it's been kept at all the wrong temperatures, you should probably still use it in an emergency because there's a good chance it will still work. Not a big enough chance that they recommend using expired pens, but enough that if the choice is probably dying or using it, you absolutely should use it.
Of course you should try an expired EpiPen if that's all you have during an emergency. But that doesn't mean you should ignore the storage temperature requirements for EpiPens, even if they are currently a bit conservative, and Neffy's better performance in high temperatures is a huge advantage.
Why would they retest and recertify so they can sell half the product they used to sell? What company is crazy enough to lose that much money?
This is a medical product. It's sold for like 100x cost. It'll still be more than worth it.
Assuming they were going to do that, it'd likely still be much cheaper to trade the old one in and discard it and get a new one.