32

Heard a bunch of people claiming that there was a study that EpiPens were found to be medically effective well past their expiration date.

Is the claim true, and if so how sound is the study?

user5341
  • 31,075
  • 8
  • 130
  • 178
  • 3
    This comes down to "what is effective?", but I found an interesting side-effect in [this](http://time.com/4471773/expired-epipens-what-you-need-to-know/) Time article: *“The primary concern is that epinephrine will oxidize over time, and because of that, create a byproduct that is associated with hallucinations and other psychiatric symptoms.”* It certainly shows that it isn't smart to keep the same EpiPen with you till you need it. – Jordy May 09 '17 at 14:58
  • 2
    @Jordy - googling around, the quote used was "the vast majority of the pens we tested **were clinically potent**" – user5341 May 09 '17 at 15:00
  • 2
    I think that definition is on par with CPerkins answer. – Jordy May 09 '17 at 15:03
  • 2
    Where's the "notable claim" in this question? I thought it needs to be published or whatever. – cat May 09 '17 at 20:24
  • 40
    This really isn't that surprising. The expiration date on things doesn't represent the absolute last date it will be safe. It represents the end of the time period which the manufacturer is confident *all units* will still be of acceptable quality (assuming proper storage, etc.). Even if a company wanted to find out an exact date, there's probably a good amount of variability just depending on precise details of the production and the care. – jpmc26 May 09 '17 at 22:32
  • 4
    Common sense says yes. They're not going to immediately stop working on their expiration date. They may just decline in effectiveness past the manufacturer's guarantee. – user253751 May 09 '17 at 23:43
  • 9
    My understanding of US drug expiration dates is that they are the point the manufacturer promises that the drugs are at least 90% as effective at the time of manufacture, assuming they were stored properly. As this is a low bound, not an average, most drugs will retain more than 90% effectiveness at their date. – Loren Pechtel May 10 '17 at 02:41
  • 1
    It's the same for food. "Best before...", "Use by..." etc. etc. are *legal* statements, and just give a certain point on the probabilistic curve of "good" vs. "spoiled". – DevSolar May 10 '17 at 13:38
  • 1
    @DevSolar: Actually, at least in the EU, there are specific rules for the use of "Best before" vs. "Use by". I think the relevant regulation is [1169/2011](http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32011R1169). "Use by" is for "foods which, from a microbiological point of view, are highly perishable and are therefore likely after a short period to constitute an immediate danger to human health". Other stuff gets "Best before", or no date at all (fresh fruit, alcoholic drinks...). And yes, they only indicate probabilities and minimums (the "date of minimum durability"). – sleske May 11 '17 at 08:30
  • 1
    @jpmc26 Moreover, even, it's the date the manufacturer is willing to *guarantee* this, which is possibly a bit earlier still than when they are confident about it. – Jasper May 11 '17 at 12:12

1 Answers1

58

Yes, there was such a study, if by "medically effective", you mean something like "better than not using any epinephrine treatment".

From the NIH, a study first published in the Journal of Allergy and Clinical Immunology titled "Outdated EpiPen and EpiPen Jr autoinjectors: past their prime?":

For prehospital treatment of anaphylaxis, we recommend the use of EpiPen and EpiPen Jr autoinjectors that are not outdated. If, however, the only autoinjector available is an outdated one, it could be used as long as no discoloration or precipitates are apparent because the potential benefit of using it is greater than the potential risk of a suboptimal epinephrine dose or of no epinephrine treatment at all.

The linked abstract is pretty clear: the effectiveness does decline, and some units will be discolored or contain particulates, but the data appear to support a conclusion that if you have no other choice, an expired treatment is better than none.

David Mulder
  • 4,124
  • 2
  • 23
  • 41
ReasonablySkeptical
  • 4,350
  • 3
  • 15
  • 18
  • 65
    Much like when you're starving, spoiled food is *slightly* better than no food. Eat the spoiled food, you *might* get sick. Don't eat the spoiled food, you *definitely* starve... But that doesn't mean that anyone sane recommends keeping spoiled food around just in case you'll ever find yourself starving. – Shadur May 09 '17 at 15:18
  • 1
    @Shadur - Agreed, good simile. Also, no one sane recommends ignoring spoilage or expiration dates altogether. But yeah, even spoiled food beats starvation. – ReasonablySkeptical May 09 '17 at 15:53
  • 12
    The thing is, many of the expiration dates on drugs are set for commercial considerations, as well as safety and efficacy. Consider how the exact same drugs can have different expiration dates in the USA and Europe. – PoloHoleSet May 09 '17 at 19:15
  • 4
    @PoloHoleSet I agree that's true, but that doesn't make expiration dates uselessly arbitrary. The study I linked shows that there is a correlation between decline of epinephrine and number of months past the expiration date. And at some point, you start getting discoloration and precipitates (which I believe are associated with negative side effects). – ReasonablySkeptical May 09 '17 at 19:18
  • 1
    Not uselessly so, but before tossing a pen I'd probably check to see what its European expiration date would be. – PoloHoleSet May 09 '17 at 19:43
  • 7
    @PoloHoleSet Are the differences in expiration date due solely to administrative decisions, or are there differences in any preservatives used? – chepner May 09 '17 at 21:05
  • @PoloHoleSet Are you going to check the European expiration date while you are having a bad asthma attack, or just inject it? – kingledion May 09 '17 at 22:50
  • 11
    @PoloHoleSet Do the USA and Europe have different standards for how much degradation is acceptable? – user253751 May 09 '17 at 23:45
  • 3
    Maybe different *handling* procedures (e.g. temperature) in different countries, so the EU date doesn’t apply to US items. – JDługosz May 10 '17 at 10:36
  • 12
    Different handling could be an issue when comparing expiration dates between different countries. For example, eggs in Germany are not refrigerated but in the US they are. The difference is that the US relies on cleaning the eggs before sale in order to get rid of any germs, but the cleaning destroys the natural protection of the eggs so you have to refrigerate them, whereas German eggs are not even washed in order to keep the protection intact, so you can store them at room temperature but have to wash them before use. I don't know examples in medicine but it seems plausible that they exist. – Sumyrda - remember Monica May 10 '17 at 11:23
  • 3
    @Sumyrda What! You have to wash eggs in Germany? I have never heard of doing that, and have never done it. In fact I grew up on a chicken farm, so I know that eggs are often washed when they are visibly dirty, but otherwise not. Germans generally keep eggs in the fridge at home, though in the supermarket they are displayed on normal shelves. – RedSonja May 10 '17 at 12:31
  • 3
    @RedSonja maybe "have to" is too strong an expression but eggs from the German supermarket sometimes have some dirt or feathers on them - and even if they don't have visible dirt on them, that doesn't mean there isn't dirt on them. So yes, you might want to wash them, but of course you're free not to do that and it probably won't be a problem. Also, you can store the eggs in the fridge and many people do, but you can also just keep them in a cupboard for a few weeks and some people do that, which is supposedly not possible with US supermarket eggs (although I've only done it with German eggs). – Sumyrda - remember Monica May 10 '17 at 13:13
  • 1
    @immibis you are right, we do have different standards for freshness and safety of drugs, and totally separate and unrelated paths to have drugs and expiration dates of drugs validated and accepted. Also, different handling rules, different rules on allowed packages and so on. Similar, but certainly not the same. – Mołot May 10 '17 at 13:50
  • @kingledion - That's kind of obtuse. I'm going to check the expiration date when making the decision whether to discard the product or not. If I have it and have already decided to keep it, there's nothing to check if I have an asthma attack. – PoloHoleSet May 10 '17 at 13:54
  • 3
    @Sumyrda - Huge populations of chickens living in small, crowded, enclosed areas, covered in their own feces in "factory farm" conditions is the cause for the US need to wash the eggs. It's my understanding the other nations are not so lenient in allowing those kinds of operations, and certainly not with the minimal level of regulation that we do here for any that might be allowed. – PoloHoleSet May 10 '17 at 14:01
  • 1
    I find the best way to approach expiration dates is to treat them as a duration of fungability. Within the window, you should feel comfortable treating any one pill (or pen, etc.) just the same as any other pill within the expiration period. You don't have to be concerned about their history because any pill should be as good as a fresh pill. After the expiration date, you no longer have this guarantee. You must now consider *your* pill or *your* pen and what it has gone through (some of which might even be invisible). It is now different, and may work or may not. – Cort Ammon May 10 '17 at 23:25