Degraded tetracycline has been documented to be dangerous in those who are suffering from renal failure.
There's also the possibility that a person may be suffering from a new undiagnosed condition, which hadn't yet onset when they were initially prescribed the drug. In this case you could think of it less as an expiration for the drug, and more of a suggestion to seek additional medical guidance on continuing after a certain date.
There's also the remote possibility that a new drug is developed which could potentially become dangerous when expired. The general population would have to unlearn little morsels of knowledge such as this, in the meantime people could be harmed.
Edge cases like this are enough in my opinion to warrant not spreading blanket advice like this, even if it's nearly always true. Erring on the side of caution is the best approach with medical affairs, even if it costs a bit extra monetarily. Giving patients potentially dangerous advice so they can save money is ethically questionable at best.
> I was strongly under the impression that medications with expiration dates do not become dangerous after their expiration, but they may be less effective.
A few like tetracyclines can become dangerous, apparently that's caused Fanconi syndrome and other kidney problems in a few cases. But that drug is the exception rather than the norm, but since I used to keep doxycycline around for treating Lyme I made sure it was stored in a cool/dry area and never got too far past the expired date.
Aspirin is a pretty easy one to tell if it's past its prime, it'll smell like vinegar as it decays into acetic acid. This falls into the 'loses its potency' category where the thing it decays into isn't harmful.
(former pharmaceutical developer here). This article makes it sound like there's a big conspiracy, which there isn't.
A very few drugs (like erythromycin) become toxic so should be discarded.
Some drugs become less efficacious over time, but nobody really knows the shape of the curve as they are simply tested to see if they have the same efficacy on day E as they did on day 0. Well of course all drugs will become worthless as t approaches 8 but you can guess that since tablets have a very low moisture content, if they are kept in a cool dark place it's likely they'll last a very long time. I also happily keep expired drugs in a controlled environment and use them; all drugs in my car's and backpack's first aid kits get replaced annually because they are exposed to harsh environments.
(Stockpiling drugs doesn't prove anything BTW: if you are stockpiling them against an emergency the presumption is that some efficacy is better than none).
Nobody is going to do accelerated life testing beyond what they have of course. I think extending the required lifetime is a good idea, though I question the size of the economic return claimed in the article.
The expiration dates on food are slightly more scandalous: the FDA doesn't require the same level of testing as they do on the medical side so they are mainly set stupidly short. Last week purchased some vacuum-packed lamb that had a manufacturer label with an expiration date a month away, but was prominently labeled to expire this week. And of course US egg producers take steps that reduce the storage time of eggs, which can be months old when you get them -- and then "expire" a week after getting home.
I was strongly under the impression that medications with expiration dates do not become dangerous after their expiration, but they may be less effective.
if my reading of the shelf life extension program paper from 02006 is correct, doxycycline is especially good at surviving past its expiry date. maybe manufacturers are especially conservative about doxycycline expiration dates due to the toxicity risk? the paper didn't mention toxicity risk or safety at all
Even if it didn't cost a dime, some drug companies might not be interested in longer expiration dates. If the expiration date is passed, and you throw it out, you'll have to buy a new supply. More profit!
It's a perverse effect, but that's the way it is.
I believe the OP's point is that really isn't when it not be effective but when you are supposed to throw it away as per the FDA. It could very well be effective well past that expiration date.
> Lot of expiration dates you see in medicines is FDA regulated and should be taken seriously.
This is not true. The FDA dates are ultra-conservative for liability reasons. The military has done a lot of research (well, asked other people to do research) on this, and found that the vast majority of "expired" medicine is perfectly fine:
> To save money on regularly replacing its drug stockpile, in 1985 the US Air Force asked the FDA to test some products. Since then, the FDA has found that 90% of over 100 prescription and over-the-counter drugs tested could be used safely past their expiration date, a Pentagon spokesman told the Associated Press, adding that the dates tended to be very conservative. Products were tested by either the manufacturer or the FDA, but always with agency supervision.
I would assume there's also liability to think about. If something goes wrong with a medicine after the expiration date it has to be better for the manufacturer. Also you probably want to leave some room for suboptimal storage
....and be a smart person and throw away what is expired
I understand what you mean but the advice to 'throw away what is expired' is just plain silly. Throw away what has spoiled, use the rest. Make sure to rotate your storage - first in first out - and use what you rotate out. Expiry dates are theoretical limits, not absolute cut-offs. This goes for not only food but also for medicines, most pharmaceuticals work just fine after the expiry date [1].
A big chunk of this article's message is that those considerations seem to not have anywhere near as much of an effect as currently assumed. (EpiPens viable 50 months past their marked date)
I would push two prongs: reinforce that expiration dates are serious, and at the same time test and extend any/all dates to the actual behavior of each drug. turn a one year into 5, 10, 20? Hell yes.
Pretty obvious that big chunks of the health care system are rigged for profit, not efficiency or usefulness.
I had a similar 'secret language' experience, though not at all related to AS. I have a diabetic pet, and the vet was explaining how to use insulin. Naturally, one of our concerns was cost. He kept mentioning how he'd seen many people use insulin for months after it's expiration-date. He was clear that you should "always follow the instructions", but that occasionally he'd seen people use old insulin, and, as long as they were consistently checking their glucose, it worked fine for them.
We finally figured out his message: The insulin expiration date might or might not be valid. Testing is better than going by the bottle's expiration date, within reason of course. He couldn't tell us to ignore the date, but he could tell us about when he'd seen it work past the date.
The main problem is that there just isn't data on how much these drugs degrade. The expiration date is based on some preliminary measurements and conservative guesstimates. Neither the FDA nor the drug companies really cares or wants to see these dates extended.
Nobody said they need to find the absolute last day the drug expires before they can get it to market.
If it's a new drug and they can only say for sure that it lasts 6 months then put that on the label and ship it out. But assuming the drug will be out for 10+ years they should be continually testing the expiration date and updating as they've had more time to make that determination.
But like I said initially (and as you nicely pointed out) that costs money so why bother?
> The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations.
What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured", and the sentence implies some of those dozen weren't close to 100%.
> The idea that drugs expire on specified dates goes back at least a half-century, when the FDA began requiring manufacturers to add this information to the label. The time limits allow the agency to ensure medications work safely and effectively for patients. To determine a new drug’s shelf life, its maker zaps it with intense heat and soaks it with moisture to see how it degrades under stress. It also checks how it breaks down over time. The drug company then proposes an expiration date to the FDA, which reviews the data to ensure it supports the date and approves it. Despite the difference in drugs’ makeup, most “expire” after two or three years.
That seems to be the problem. There was a procedure in place to set expiration dates scientifically, and it was ignored for some reason, limiting the legal shelf life of even the most stable compounds to a few years.
Beyond that, what is the incentive on the part of the company? No one is evaluating medications based on shelf life. Longer expiration dates -at best- do nothing favorable for the company, and at worst both reduce the purchase of more of the drug, -and- open the company up to litigation in the even it's dangerous. Why take that risk? There is simply no economic pressure to.
You are right, I was concentrating more on the second half of the quote which is about someone's personal experience. If what they describe is what they've encountered, it should not have an expiry date.
For the extrapolating "surprisingly large fraction" part, I have no idea. Maybe someone is keeping count on these numbers; it would be interesting to see them.
There's also the possibility that a person may be suffering from a new undiagnosed condition, which hadn't yet onset when they were initially prescribed the drug. In this case you could think of it less as an expiration for the drug, and more of a suggestion to seek additional medical guidance on continuing after a certain date.
There's also the remote possibility that a new drug is developed which could potentially become dangerous when expired. The general population would have to unlearn little morsels of knowledge such as this, in the meantime people could be harmed.
Edge cases like this are enough in my opinion to warrant not spreading blanket advice like this, even if it's nearly always true. Erring on the side of caution is the best approach with medical affairs, even if it costs a bit extra monetarily. Giving patients potentially dangerous advice so they can save money is ethically questionable at best.
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