Can you use an EpiPen after the expiration date?
The EpiPen is likely to be okay up to 2 years past the expiration date.
An authentic definition of an expiration date is not the date that the drug stops being effective or potentially becomes toxic. It is a date, required by law, that the manufacturer can guarantee greater than 90% original potency of the medication.
PS. Food expiration dates have nothing to do with safety, too. A tad more on this later.
Epinephrine
Epinephrine is a costly drug and is usually replaced when the Epipen expires. Retail costs can be as high as $600 per pen. Weir and colleagues studied six epinephrine syringes 30 months past their expiration date. Three of the syringes and one control, non-expired syringe were analyzed using liquid chromatography-mass spectrometry and nuclear magnetic resonance to determine epinephrine content. The contents of the other three syringes of epinephrine were cultured for bacteria and fungus, which yielded no microbial growth.
The study showed that the content of epinephrine present in the original sample remained unchanged, compared with the control. Rachid et al. looked at 35 EpiPens 3-36 months past their expiration dates.[2] The percentage of epinephrine found remained 84%-101%, with all EpiPens less than 24 months past expiration having > 90% of the labeled epinephrine dose. Cantrell and colleagues evaluated a combination of 40 EpiPens and EpiPen Jrs that were 1-50 months past expiration.[3]
Caveat: These pens had not been kept in ideal conditions, as some had been in cars, outdoor cabins, and other environments without temperature control. Sixty-one percent of the Epipens and 56% of the EpiPen Juniors had > 90% of the labeled epinephrine content.
The moral of this story: Keep expired Epipens as backup options – they are safe to use if there is not an EpiPen available that is not expired.
Shelf Life Extension Program for Other Meds
Lyon and colleagues reported data from the Shelf Life Extension Program (SLEP).[4] A total of 122 drugs were studied representing 3,005 lots. Based on testing and stability assessment, 88% of the lots were extended at least 1 year beyond their original expiration date for an average extension of 66 months, but the additional stability period was highly variable.
Several antibiotics were studied, including ciprofloxacin (mean extension, 55 months), amoxicillin (mean extension, 23 months), and doxycycline (mean extension, 50 months).
What about other drugs not in pill form?
Liquid Eye Medicine
I take Latanoprost, a liquid eye medicine to keep optic nerve pressure more stable and healthy. So this interested me greatly. They are liquid eye drops. What about them? Crazy enough, there is little data on this.
Reis et al. studied whether travoprost that was past the expiration date still lowered intraocular pressures (pressure in the optic nerve).[5] Intraocular pressures in glaucoma patients treated with travoprost 6 weeks after the seal was broken were compared with pressures when drops were used immediately after the container seal was broken. There were no significant differences in intraocular pressure between the two treatment groups during the study.
The author of this Medscape article did find one case report of “harm” from using expired eye medications. The use of expired eye drops was associated with a case of bilateral toxic epithelial keratopathy.[6]
Eye drops can be contaminated and cause irritation from the breakdown products of preservatives.
Hmm, I don’t think I will use outdated Latanoprost. Expired eye meds should be thrown out. Many eye meds need to be refrigerated. This is critical, too. One day not refrigerated does not nullify protection, but effectiveness and safety go way down after 24 hours of non refrigeration.
Inhalers?
Many folks have used inhalers for a long time, even years. This is especially true for albuterol, which is often used for very intermittent symptoms.
Kutty et al. studied expired albuterol inhalers and solutions up to 20 years past expiration.[7] Almost all lots of albuterol maintained > 90% of the product (73%-103%), many years past their expiration date. Even at 73% retained activity, the dose would, according to most doctors, likely be effective.
Pearl: Expired epinephrine and albuterol appear to retain activity several years past expiration.
Probably so do a lot more meds.
The Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration published in the Journal of Pharmaceutical Science, says in their abstract:
The American Medical Association has questioned whether expiration dating markedly ‘underestimates’ the actual shelf life of drug products.
Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. This program probably contains the most extensive source of pharmaceutical stability data extant.
This report summarizes extended stability profiles for 122 different drug products (3,005 different lots).
The drug products were categorized into five groups based on incidence of initial extension failures and termination failures (extended lot eventually failed upon re-testing).
Based on testing and stability assessment, 88% of the lots were extended at least ‘1 year beyond’ their original expiration date for an average extension of 66 months, but the additional stability period was highly variable.
The SLEP data supports the assertion that many drug products, if properly stored, can be extended past the expiration date.
The Creighton School of Medicine published this in StatPearls in May 2023:
Excerpt
In 1972, the United States Congress passed the Drug Listing Act to allow the Food and Drug Administration (FDA) to have an up-to-date list of all drugs that are commercially distributed.
The law stated that all commercially available drugs were to have a unique National Drug Code (NDC).
Every drug establishment, foreign or local, involved in the manufacturing, production, or compounding of commercially available drugs for use within the United States must be listed with the FDA.
Expiration Dates were Birthed in 1979
Starting in 1979, the United States Food and Drug Administration stated that all prescription and over-the-counter (OTC) medications would need an expiration date.
After September 27, 1979, any drug product packaged is required by law to contain an expiration date.
This expiration date would guarantee a medication's stability and efficacy up to that date in the original container.
All expiration dates must be clearly printed on the labels of medications. But many drugs are pretty good up to one year after this date. So take expiration dates with a bit of breathing space. (Even EpiPens.)
Food
With food being so expensive these days, what’s the reality show regarding food expiration dates?
Generally speaking, it is safe to buy food even on its expiration date. Expiration dates have more to do with the food's overall quality and texture instead of when it is safe or not safe to eat. As long as there are no signs of spoilage, you can eat it, but it might not taste as fresh as it once was.
Expiration dates, confuse us about what’s actually edible. They do so by insinuating that food has a definitive point of no return —and it might be dangerous to eat. But…most expiration dates convey only information about an item’s quality. With the exception of infant formula, where they really do refer to expiration.
Food expiration dates generally represent a manufacturer’s best estimate of how long food is optimally fresh and tasty, though what this actually means varies widely, not least because there is no federal oversight over labeling. For example, milk in Idaho can be “sold by” grocery stores 10 days later than in neighboring Montana, though the interim makes no difference in terms of quality. Some states, such as New York and Tennessee, don’t require labels at all. Food expiration labels came about in the 1970s, too. Just like drug expiration labels.
Emily Broad Leib, a Harvard Law professor and the founding director of its Food Law and Policy Clinic, co-authored a study in 2019 that demonstrated that 84 % of Americans at least occasionally throw out food close to the date listed on the package.
But quality and safety are two very different things. Plenty of products can be edible, if not tasty, long past their expiration date. Safety, to food experts, refers to an item’s ability to cause food poisoning that lands folks in a hospital.
Take milk, one of the most-wasted foods in the world. Milk that has already soured or curdled can—get this—still be perfectly safe to consume. (In fact, it makes for fluffy pancakes and biscuits and … skin-softening face masks.) If you take a sip of that milk, you’re not going to end up with a foodborne illness.
In fact, anything you will go on to cook in the stove or oven is safe past its expiration date, so long as it doesn’t smell or look odd.
In “industry speak” cooking is a “kill step”—one that destroys harmful interlopers—if done correctly.
Pantry Items
Generally, dry goods never become unsafe, even if their flavor dulls. You’re not taking your life into your own hands if you’re eating a stale cracker or cereal. If labels were focused on safety, this would make our interpretations easier.
Unsafe Food
Food is considered unsafe if it carries pathogens such as listeria, E. coli, or salmonella that can cause foodborne illness. These occur from contamination, like when E. coli–tainted water is used to grow romaine lettuce.
Proper storage, which means temperatures colder than 40 degrees Fahrenheit (your fridge should be at this temp) or hotter than 140 degrees Fahrenheit, inhibits their growth (except for listeria, which is particularly scary because it can thrive during refrigeration). It would be extremely difficult for any label to reflect all of this information, especially given that unsafe storage and contamination tend to occur after purchase, in hot car trunks, and on unsanitized countertops.
Pregnancy!
There is one category of food that should be labeled. “Foods pregnant women should avoid,” such as deli meats, raw fish, sprouted vegetables, and unpasteurized milk and cheese. These require extra caution because they can carry listeria, which is invisible to the senses, and are usually served cold—so they don’t go through a kill step before being consumed.
Just Think
In America, dates have become a tradition. But we are all now vulnerable to “wallet-ectomies” from inflationary food prices.
Use your judgment. What a concept.
Stop letting others think for you. Manufacturers, meanwhile, maintain date labels because they don’t want to risk consumers buying products past their prime, even if they are safe and still (mostly) tasty.
You can look stuff up. FoodKeeper, an app developed by the U.S. Department of Agriculture, lets users look up roughly how long food lasts.
The Waste-Free Kitchen Handbook, by the food-waste pioneer Dana Gunders, gives detailed practical advice, such as scraping half an inch below blue-green mold on hard cheese to safely recover the rest. What a concept!
There is always the smell test. If Covid ain’t got your olfactory bulb to take a break. Your senses can give you most of the information you need. “If something smells off, toss it.” But because most people are out of practice, as we have been relying on these expiration dates as though they are inscribed by Moses in cement, we struggle to tell good from bad or don’t trust their senses. Smell food regularly. Get your nose into things. Practice sniffing. Many of us eat out often. We go to Whole Foods but tend to buy pre-prepared food. Americans are “several generations removed now from agriculture and food production”, so we don’t know our food as well as they once did.
Let’s reboot our relationship with food. And with meds in our medicine cabinet.
Let’s protect our funds. And our health.
Dr. B.
References
Rachid O et al. Ann Allergy Asthma Immunol. 2015 Apr;114(4):354-6.
Cantrell FL et al. Ann Intern Med. 2017 Jun 20;166(12):918-9.
Lyon RC et al. J Pharmaceut Sci. 2006;95(7):1549-60.
Reis R et al. Clin Ther. 2004 Dec;26(12):2121-7.
AlGhadeer H, AlHumaiden A. J Clin Pharm Ther. 2022 Dec;47(12):2379-82.
Kutty RG et al. Heliyon. 2022 Aug 5;8(8):e10104.
NY Times Food Expiration Dates June 19, 2023
Douglas A. Paauw, MD More on Using Expired Medications - Medscape - Oct 02, 2023.
Stability profiles of drug products extended beyond labeled expiration dates. J Pharm Sci. 2006 Jul;95(7):1549-60
Expiration Dating and National Drug Code Rules. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan–. PMID: 34033382.
https://www.theatlantic.com/health/archive/2022/11/expiration-dates-food-waste-safety/672311/