Question: I have severe food allergies and I’m at risk of suffering anaphylaxis, making it difficult, maybe even impossible, for me to breathe. I always carry an EpiPen auto-injector just in case I need emergency medicine. Now I see in the news that these life-saving products are in short supply. How long will an EpiPen still work after it’s past its expiry date?
Answer: The medication in an EpiPen doesn’t suddenly become useless once the expiry date on the label has gone by. But how long it remains effective is a matter of some debate and conjecture. That uncertainty also applies to other prescription and over-the-counter drugs.
More accurate dating might reduce the waste that results from the disposal of unused, expired drugs and could potentially save patients and health care systems a lot of money.
Before reviewing the evidence, though, a bit of background is in order.
Pfizer is the sole Canadian supplier of an auto-injector (known by the brand name EpiPen) that enables patients to quickly give themselves a shot of epinephrine which acts as an antidote to anaphylaxis, a potentially deadly allergic reaction.
The company says a “manufacturing issue” has led to delays in shipping new supplies of the adult-dose EpiPen to pharmacies, some of which may run out of stock before the end of August.
This supply problem prompted Health Canada to take the unusual step of advising patients to use an expired EpiPen—if that’s all they have—and call 911 to get to a hospital emergency department.
In general, drug manufacturers are required to provide Health Canada with evidence that their products retain potency for at least a certain period of time. “Expiration dates indicate the time at which the full potency and safety of the medication may begin to diminish,” says Christina Antoniou, a spokesperson for Pfizer Canada Inc.
Typically, the expiration dates for most drugs are set at two or three years from the time of manufacture. EpiPens have an even shorter shelf life—about 18 months. But there’s been very little research done on how quickly—or slowly—drugs break down after they’re past the expiry date.
Several intriguing studies suggest that certain medications, including the epinephrine in an EpiPen, might be relatively stable and still effective for a surprisingly long time.
“We found that the vast majority of expired EpiPens had at least what might be considered a therapeutic dose for up to four years after the expiration date,” says Lee Cantrell, director of the San Diego division of the California Poison Control System.
Cantrell and his research colleagues decided to do a study of expired EpiPens after the manufacturer dramatically increased the price in the United States.
He noted that many American patients had been asking their health care providers if they could use expired EpiPens because they couldn’t afford to replace them. (EpiPens come in double packages in the United States and can cost over U.S. $600. In Canada, they’re sold as singles with a price of about $100.)
The researchers collected 40 expired EpiPens from patients and physicians at a community health clinic. The samples ranged from one month to 50 months over the expiry date.
“Although we observed declining concentrations of epinephrine over time, we expect the dose available 50 months after the expiration date would still provide a beneficial pharmacologic response,” say the researchers, whose results were published in 2017 in the Annals of Internal Medicine.
Cantrell led another study that suggests expiry dates significantly understate the actual shelf life of many other medications.
Through a colleague, he gained access to a box of old medications that had been stowed away in a family-run pharmacy.
Some of the drugs—which included pain relievers, diet pills, and stimulants—were still sealed in their original containers and exceeded their expiry dates by 28 to 40 years.
An analysis of the contents revealed 12 of 14 drug compounds were present in concentrations at least 90 percent of their labelled amounts, which is generally considered an effective dose. The results were published in 2012 in the Archives of Internal Medicine.
Despite his own study findings, Cantrell does not recommend the use of expired drugs.
“You can’t say in broad strokes that all medications are good well past their expiry dates,” he says. Some drugs—such as acetylsalicylic acid (ASA or Aspirin)—are known to break down relatively quickly.
What’s needed, says Cantrell, is more research to determine the true shelf life of most medications.
But, he laments, “it’s not in the financial interest of any pharmaceutical manufacturer to do those studies.” After all, they make money whenever an expired drug is discarded and a new one purchased.
“If we had additional data, we could potentially save billions in health-care dollars,” says Cantrell.
In fact, the U.S. government—which stockpiles medications in the event of a national emergency—took action long ago to reap some of those savings.
In 1986, the U.S. military, along with the Food and Drug Administration, established the Shelf Life Extension Program. Samples of drugs stored by U.S. government agencies are routinely analyzed. If they pass a potency test, their expiry date is extended.
Unfortunately, the U.S. government doesn’t routinely share those test results with anyone else. So pharmacists and health care institutions are professionally obligated to adhere to the existing expiry dates.
“The bottom line is the safety and health of the patient,” says Karen Lam, a pharmacist at Sunnybrook Health Sciences Centre in Toronto.
“In emergency situations like the current EpiPen shortage, we do suggest patients use their expired EpiPen because some medication is better than none, especially in life-saving situations,” she explains.
“However, if there is a choice between the expired and the non-expired EpiPen, I would always recommend the one that’s not past the expiry date.”
Sunnybrook’s Patient Navigation Advisor provides advice and answers questions from patients and their families. This article was originally published on Sunnybrook’s Your Health Matters, and it is reprinted on Healthy Debate with permission. Follow Paul on Twitter @epaultaylor.
If you have a question about your doctor, hospital or how to navigate the health care system, email AskPaul@Sunnybrook.ca
The comments section is closed.
This was hardly what I would call a clear answer about epi pens and their usefulness and safety after they expire. More double talk because nobody wants to be held accountable if something happens if someone uses a expired epi pen. That I understand, to a point.However, who do we turn to get a straight answer about it?
I went to the pharmacy and they flat out refused to give me a answer. I was then told to call the manufacturer about it. Really? More gutless BS!
My wife is a nurse in private practice and she has severe food allergies to mushrooms. As our workforce speaks and understands less english she has a epi pen with her all the time now in case they don’t understand the ” No mushrooms!” Or she may die statement from her to them.
She did a little research and she got her two pack for 15 dollars. Through better Rx or something other than our Blue Shield. The Dr. She work for is going to write me a prescription for two also. For the first time in my life My mouth is tingling and throat is itching after eating at restaurants. Why? Who knows, but I will have one with now….Our lives, our food, our water, our air is being destroyed in case you haven’t noticed. I’ve also never had pets with so many allergies to everything..My cats may need a mini epi soon….
I feel this answer is not clearly explained. I’m not sure if I should put it in my diabetic sharps container or toss it in the trash.
My epi pen was issued July 2020 when I began my allergy shots. I did not notice the expiration date: March 21.(8 months?) I paid 266 dollars for it. Now, the refill has been called in–another 266 dollars–I have never had a reaction. I am only allergic to pollen, grass, trees–no food….I made it 62 years before getting allergy shots for sinus congestion and an epi pen comes with it?
This time when I pick up my prescription at the pharmacy, I will look at the expiration date before I pay for it. I will insist on the product have more than 8 months shelf life.
How long is supposed to last a fresh new prescription of epi pen.( 1 or 2 year)
Why is the government not doing anything to control this problem that causes excessive cost to their voters?
My daughter is Alergic to bee stings she has a Epi pen usually renews it every 12 months, how long after the use by date should it be renewed,
sincerely
Janette Martin.
My Dr told me if the liquid was clear it was still good.I learned to look at the expiration date when I get a new one.If the date isn’t at least one year out I ask for a newer one.
I’m new to be allergies of yellow jackets just used my first EpiPen the articles were very helpful considering I pay $110 for 2 pens . Fall is here and I was just stung but it’s good to know the pens have a longer shelf life .
Who would I donate an expired epicenter to for research?
Who would I donate an expired epicenter to for research?
Amazed by how many comments are from people in the US (this being a Canadian site). I can’t believe they charge $600 for two pens in the US for a lifesaving drug! Seems a disgusting way to make such a huge profit. Luckily I’m Canadian and my epi pens don’t cost me, but it rules me when I hear this type of thing since I have so many dear friends in the US. I wonder how many in the US know that their government spends more money per person (nearly double what Canada pays!) on healthcare… yet you’re also expected to pay for doctors, hospital visits, and crazy high drug costs. I personally wish Americans would revolt about this. Pretty much every other western country has free health care and yet the US pays more per person than any of them. VOTE people. You need a leader who actually cares about your citizens!
Yes I’m looking at my expired EpiPens and thinking what a waste. I was looking at the little window and the liquid still looks clear to me, seems like their should be something could be done with these pens. I just read the pens are good up to fifty months, is this correct?
I just read all the comments. I inherited food allergies from my grandmother. I started in my 30’s. One of my sons inherited my food and bee allergies which started in his 20’s. My Dr ordered a 2 pack EpiPen for me and I gave one to my son who couldn’t afford to pay for them at the time. He has a 9 year old son who we are praying doesn’t inherit our allergies. Although my son and I both are allergic to MANY foods. We are allergic to different foods.
I just went through my EpiPens and they expired in 2014, 2016 and 2017. I’m going to use the 2017 first then the 2016 when I need it. Your article was very helpful.
Thank you
It would also be helpful if someone would post a photo of the discolored epipen, since the product says do not use if discolored. The liquid already has a slight tint to it, and it would be helpful to see one side-by-side with a discolored one.
dear.
I need to know about adrenalin injetion. What happen if I use for the Patient adrenalin injection after expired.
Thank you, this information was very helpful.
I find your comments regarding the epipen expiry life closure to what I had been told in the past,
but this morning I went into a local pharmacy to hand my expired epipens in for them to dispose of
and I was told they could be used if needed for at least 5 years after the expiry date. Is this correct?
I recently had to use an EpiPen that had a 4 year old X date after being stung by a hornet. It WORKED Fine!!!
M Faulson, Thank YOU for your honesty and input. BIG PHARMA and AFFORDABLE HEALTH in this country have a tight grip on American’s personal finances. I practiced nursing for over 40 years in this USA. With PREexisting conditions like DIABETES working and insured Americans are forced to pay for injectable insulin, syringes and blood slugar testing strips out of their own pocket. I am now a MEDICARE health consumer. Even with paying my own pharmacy insurance. this insurance will not pay for Injectable Epinephrine !! or even give YOU any discounts !! Sue Sweet REGISTERED NURSE, BSN
Ruth Baker, Thank you for this information. The pharmaceutical companies in this country have a tight grip on everyone’s finances and affordibility !! I am a registered nurse and have been for over 40 years. The health insurance companies and BIG PHARMA have taken advantage of Americans for decades. I am under MEDICARE rules and regulations. Guess what ?? MEDICARE HAS CLAMPED DOWN ON MANY preexisting conditions. Diabetics still have to pay for INJECTABLE INSULIN, blood sugar strips and needles to inject this daily .
That is a most interesting article. I have often wondered about that myself. I have been involved in the medical field whereas my involvement is directed at establishing access to affordable health care and controlling cost. This one single issue could save an emense amount of money and lower health care costs by a significant margin. Well with further study.
Robert, Thank YOU for your information and absolute frankness or honesty. I have been a practicing registered nurse for over 40 years in this Country. BIG PHARMA and AFFORDABLE HEALTH INSURANCE programs have had a tight grip everyone’s personal income for decades. Diabetics are forced to purchase their own injectable insulin, syringes, blood sugar testing strips, insulin pumps for years. They have never had coverage for any of their daily life sustaining supplies. I now am under Medicare Rules. Even with Drug Insurance Coverage the policy will not reimburse you for INJECTABLE EPINEPHRINE. Sincerely, Sue Sweet BSN MACEP
I understand that businesses in the drug industry is not a good one they charge thousands of dollars for medicines that save a life but small amounts for the meds people get addicted to. My spouse has hep c and twenty eight pills cost almost $27,000. But if I want zanex or hydrocodone type meds I could get it for lease than ten dollars. As a person who is in a dilemma I feel out government should step in and help this type of situation. I understand that some rxs. Are not. Good after expiration but those that are should be given to those who are not capable of paying for them and it would save Medicade and Medicare so much money it is unethical for our government not to take advantage of the savings and have extra money to help more of our citizens instead of them feeling that there is no sense in trying to get help because they could not afford it anyway. We as a nation need to look into this matter and help our fellow Americans. I would check to see who is invested in the meds world and maybe sure our elect is not making a profit at Americans welfare and. Well I will stop now
A friend has two unopened bottles of Hep C meds and has no idea what to do with them. It’s ridiculous what those cost!