Expired Epipens are better than nothing

The Pediatric Insider

© 2017 Roy Benaroch, MD

A small study published this month showed that most Epipens retain their potency for at least 4 years after their expiration date. That’s no guarantee, of course. I’d still recommend as a “best practice” that families replace them as they expire. But it’s reassuring to know that they’ll usually be effective even when expired. And using an expired Epipen is almost certainly better than using nothing when there’s a life-threatening allergic reaction.

It’s a simple enough study. Over 2 weeks, families attending a clinic in California were asked to donate expired Epipens for analysis. They collected 40 devices that had expired up to 50 months before the study, and used state-of-the-art chemical analysis to determine the potency of the medication in the vials. None of them looked discolored or unsafe. All of the pens that had expired up to 2 and half years ago had at least 89% of their original potency, and even most of the older ones remained in the 85% range. Though overall the dose potency slowly deteriorated, all of these devices would have still been helpful to treat an anaphylactic reaction.

A few small previous studies reached similar conclusions in 2015 and 2000. Though these studies looked at the Epipen brand of auto-injectors, it’s likely that studies of similar or generic products would yield the same results.

The authors of the study aren’t recommending that families hoard Epipens, or delay replacing them – but they do point out that their findings support further studies to extend the labeled shelf life of these products. And if an expired Epipen is all you’ve got, it’s probably OK to use it as long as it’s not obviously broken or discolored.

To help keep your Epipens in good shape, store them somewhere relatively cool (not cold), and away from light, preferably in the original packaging. Do not leave them in your car in the summer. Epinephrine is a finicky sort of chemical, and light and heat will speed its deterioration. Although you can hold on to expired Epipens as a “backup”, it’s best to replace them so you’re 100% sure that you’ve got what you need when you need it.

 

Epipen alternatives – there are cheaper options

The Pediatric Insider

© 2016 Roy Benaroch, MD

Epipens have gotten crazy expensive, yes — $600 for a two-pack. Here are some alternatives that might help you save a few bucks.

#1: Wait a few weeks, and see what Mylan does. Mylan, the company that makes the “Epipen” brand of epinehphrine auto-injector, has been under a lot of pressure lately to back off their unseemly price gouging. They’ve introduced a savings card that claims to lower your out-of-pocket expense to no more than $300 dollars, and say they’ve expanded eligibility for their patient assistance program for their less-wealthy-yet-still-allergic patients. Just yesterday, they accounced a new generic version of their own Epipen, claiming it will be identical to the genuine Epipen, but at half the price. Weird, yes, selling two things that are identical (other than the price), but I suppose stranger things have happened. Give Mylan a few more weeks, and they’ll probably start giving away Epipens in cereal boxes.

#2: Find out if you really need to have an Epipen available for your child. Epipens, until recently, weren’t prescribed for many children. A robust marketing program from Mylan (including appearances by Sarah Jessica Parker on daytime talk shows) along with an expanded FDA indication for people at any risk for allergic reactions turned a niche product into a billion-dollar moneymaker – and that was before they raised the prices through the roof. A reasonable question: are all of those Epipens really necessary? Certainly, those who’ve had a life-threatening allergic reaction to a food or bee sting in the past need one available. And high risk patients (for example, those allergic to peanuts who also have a history of asthma) clearly need them, too. But what about people allergic to other foods, who’ve had multiple reactions in the past, but never anaphylaxis? What about the many people who’ve tested positive for allergic sensitization, but have never actually had any reaction at all? Doctors are loathe to withdraw an Epipen recommendation (better safe than sorry!), but there are times when all of this money could be better spent in another way. If you’re not sure if or why your child needs an Epipen prescription, ask your doctor to review this with you before you refill it.

#3: Hold on to expired Epipens, at least for a little while. Epipens keep at least some potency beyond their expiration dates, especially if they’ve been stored in a cool place. Don’t discard your old Epipens until you’ve purchased new ones – it’s better to use an expired Epipen than to have no epinephrine available when needed.

#4: Consider the Other Brand, “Adrenaclick”. Epipens have pretty much flooded and dominated the market, but there is another epinephrine auto-injector out there, the “Adenaclick.” Instructions for using it are a little different, so if you get one make sure you’re familiar with it. A two-pack lists for $140 less than Epipen, and you can get that price even lower by using a coupon from GoodRx.com. Even better: there is a generic Adrenaclick out there, and it’s even cheaper if you can find it (supplies, I’m told, are limited.) To get an Adrenaclick or the generic version, you need a specific prescription from your doctor listing this by name. In most states, pharmacists cannot substitute Adrenaclick for an Epipen. You’ll want to check your insurance formulary, too – the list prices may not matter as much as what “tier” these products fall under for your plan.

Expired Epipens – Safe to use?

The Pediatric Insider

© 2016 Roy Benaroch, MD

The sticker shock for Epipen purchases has some people wondering: Do I really have to buy a new one every year or so? Does it really matter if the drug has aged past its expiration date?

An Epipen is a device that automatically injects epinephrine. It is The Drug for potentially catastrophic allergic reactions to things like foods or bee stings. If someone’s having a bad reaction, epinephrine can save a life. In a medical situation, we’d typically draw up epinephrine from a little vial (which is way cheap, less than 5 bucks) and inject it into an available big muscle. Presto, you’re in the clear (it really can work super-quickly. Quite satisfying.) Since it’s awkward and perilous to draw up epinephrine into a syringe while you or your child is dying of an allergic reaction, for home use an automatically-injecting device is prescribed. Handy! Just remove a cap, press against the skin, and a little spring loaded mechanism fires off, poking out the needle and injecting the medicine in one E-Z step.

Those autoinjectors were first developed by the US military for treating nerve gas attacks. By the mid-1970’s a home version for allergies came out, and though the company that developed it has changed hands, merged, and moved on, the thing that’s currently sold uses pretty much the same technology. The medicine in there, epinephrine, is (and has been) dirt cheap for decades. What makes an Epipen expensive is the device used to inject it, which is currently protected by both patent law and an FDA that seems keen on making sure it’s the only widely available brand. Free from any competition, and with sales buoyed by aggressive marketing, by the manufacturer has been jacking the price through the roof.

Making this even more expensive: a newly purchased Epipen has a manufacturer’s expiration date, typically less than 2 years after purchase. So what happens after that date? Does the medicine really “go bad”?

There aren’t a lot of studies about this. I found two (thanks very much to the Simons, both F. Estelle and Keith, from Winnipeg, Canada – they’re authors on both papers!) In May, 2000, the Simons examined 34 donated Epipen injectors, administering them to 6 New Zealand White rabbits (not at the same time.) The out-of-date injectors delivered less epinephrine, and the drop was proportional to the age past expiration. The older the device, the more it lost its punch. Still, eyeballing their data in Figure 2, devices that were less than 24 months past expiration had between 60-90% of their drug intact, which isn’t terrible. They concluded that as long as the epinephrine wasn’t visibly discolored or damaged, it was better to use an expired Epipen than nothing at all.

Those same authors (with a few extra friends, minus the rabbits) looked at expired Epipens again in 2015, measuring potencies of 80-100% in devices up to three years past their expiration. Again, not too shabby.

Epinephrine is especially vulnerable to breaking down in heat. Epipens stored in car glove boxes aren’t going to last. And the auto-injecting mechanism, while robust, isn’t made for kickboxing practice or roller coaster festivals.

Still, for ordinary households who try to keep their Epipens in a cool, the devices  probably keep at least some potency somewhat past their printed expiration dates. It’s best if families replace them after they expire, to make sure they’re getting a full and reliable dose. But if someone needs a dose of epinephrine, and the only Epipen you’ve got is expired – use it.

And when you do buy a new one, make sure to ask the pharmacist to give you the new stuff, even if she has to reach way in the back. Since they’re so expensive, it might even be worth it to call around a few places, to see whose stock is the freshest.

More about drug expiration dates

Serious allergic reactions to vaccines: Something else not to worry about

The Pediatric Insider

© 2016 Roy Benaroch, MD

A huge study of over 25 million doses of vaccines has shown that serious allergic reactions are super-rare, and even when they do occur they’re typically easy to treat.

Published in the October, 2015 edition of The Journal of Allergy and Clinical Immunology, the study looked at a huge database of 17,606,500 visits for a total of 25,173,965 vaccines. This is seriously Big Data, people. After all of these vaccines, only 33 cases of a severe allergic reaction occurred. Even among those 33, only one child required hospitalization, and none died.

More reassurance: there were zero serious reactions among children less than four years of age. And most of the 33 reactions (85%) occurred in children who had a history of other allergic diseases.

Despite its rarity, anaphylaxis is a potentially serious reaction. If your child experiences a widespread rash, trouble breathing, severe GI symptoms, or fainting after a vaccine, it might be an allergic reaction – a medical evaluation is needed. Most of these reactions won’t turn out to be serious or life-threatening, but they do need attention. Almost all teenagers who faint after vaccines have just fainted, and will be fine, but they need to be watched and their blood pressure checked. If further evaluation shows it’s an allergic reaction, medical therapy given quickly can help stop the reaction.

But: we need to keep these reactions in perspective. They’re really phenomenally rare. 33 out of 25 million vaccines means that your children have a higher chance of being hurt in a car accident on the way to their appointment than of having a serious allergic reaction to a vaccine. Other, non-allergic but serious reactions are really very rare, too. The internet has made otherwise well-adjusted people into parents worried stiff over vaccines. Don’t let it happen to you. Don’t live in fear and worry. Immunizations save lives, they’re safe, and they’re something you don’t need to worry about.

Fixing peanut allergy by eating peanuts

The Pediatric Insider

© 2014 Roy Benaroch, MD

Peanut allergy can be a big deal. And most children who are allergic to peanuts will not outgrow their allergies. Avoidance has been the main way to treat peanut-allergic people, but that doesn’t always work. Peanuts can sneak into foods, especially with young children who may not be able to monitor their intake closely. What if there were an easy way to “cure” peanut allergy?

Researchers in the UK published a study last week looking at the safety and effectiveness of oral desensitization. They enrolled 99 children from age 7-16, all of whom with documented real peanut allergy by prior oral challenge (ie, they had all had serious, immediate reactions to peanut under controlled conditions in the past.) They were randomized into two groups. The control group was told to continue avoiding peanuts. The kids in the intervention group were given a daily dose of oral peanut flour, starting with a tiny dose of 2 mg, and working up every two weeks to a maximum dose of about 5 peanuts worth of protein.  Of the 49 children randomized into the intervention group, 6 withdrew from the study—four of whom because of reactions to the peanut. One child required one dose of epinephrine during the study because of a serious reaction. After the study period, all of the remaining participants in both groups had a double-blind, placebo controlled peanut ingestion to see if an ordinary dose of about 10 peanuts could be safely tolerated without a reaction.

Of the children in the control group, who had been told to just continue to avoid eating peanuts, none could then tolerate a peanut ingestion (46 of the 46 who were still participating at that time reacted.) In the exposure arm, about 85% of the participants who completed the oral desensitization scheme were able to tolerate eating peanuts. After the study period, most of the children who had been randomized into the control arm were offered oral desensitization, and they ended up doing about as well.

Though oral desensitization worked most of the time, some questions remain. It’s not known how long these children will remain desensitized—they may need to continue oral exposures daily to prevent relapse back into clinical allergy. And about 20% of the original intervention group didn’t complete the study for a variety of reasons, some of whom because they couldn’t tolerate the treatment itself. But for most of the children who could complete the therapy, oral desensitization seems very promising.

It makes sense, too—we know that early oral exposures to foods seems to prevent at least some kinds of allergies, and that policies that encouraged delaying foods (especially past six months of age) probably led to increased allergy.

However: this is still an area of active research. Please do NOT try this on your own. The research groups had specific protocols using purified proteins, and though it’s likely that widespread use of this technique will lead to a simple, home-based regimen, we’re not quite there yet. If your child has peanut allergy and you’re interested in pursuing oral desensitization, speak with a board-certified allergist about enrolling in a trial or learning more about this before you give your child any peanut.

edit 2/21/2014 — fixed broken link to study

Allergy myths

The Pediatric Insider

© 2009 Roy Benaroch, MD

I’m writing from my hotel in Washington, DC at the American Academy of Pediatrics annual national convention. It’s definitely pediatrics—some of the exhibitors were handing out lollipops today, and one even brought along a puppy to play with!

One of the best talks I heard today was from an allergist, reviewing the science behind allergy testing, when to do it, what it means, etc. But the biggest eye-opener for me occurred during the questions afterwards. I’m embarrassed to say that it’s obvious that many pediatricians haven’t got a clue about how to diagnose allergies. And if the peds aren’t getting it right, where does that leave the parents? So I’m going to skip right past your pediatrician, and today reveal…the deep dark insider story. It’s time for a top ten list, the top ten myths about allergy that pediatricians are getting wrong.

#1 Food allergies are common

Many people think they’re allergic to foods, but rigorous studies using the best, most reliable diagnostic tools find food allergies to be present in about 2-8% of the population. Most of these reactions are mild. True, life-threatening food allergies are quite rare—in the United States, about 150 people die each year from food allergies, which is only a little higher than the number of people struck by lighting.

#2 Most reactions to food are allergies

An allergy refers to a specific kind of reaction, most commonly hives or wheezing. Other, more common reactions include lactose intolerance (an inability to digest milk sugar, leading to abdominal cramps and diarrhea) and gastroesophageal reflux related to spicy or acidic foods. The distinction is important because rare, very serious allergic reactions can occur. If the reaction was not allergic in nature, it will not possibly be life-threatening if exposure occurs again.

#3 Most reactions to medicines are allergies

The most common adverse reaction to a medication is a rash, but these are usually not caused by allergy (the only common truly allergic rash is hives, which are raised, itchy areas that move about the body.) Most people labeled as “allergic” to penicillin are not in fact allergic, and can safely use this medication. Only a careful history and exam can determine this—there is no accurate test to confirm or refute true drug allergies. If you or your child is thought of as drug allergic, review the exact circumstances with your physician to see if it is a good idea to try the medication again (do NOT do this on your own!)

#4 People who are allergic to a medicine should never take it again

Certainly, if a life-threatening reaction occurred you need to be very careful. And be much, much more wary of medications given as a shot or intravenously (I’m not sure anyone has ever died as a result of an allergic reaction to oral penicillin.) But unless the reaction was a true allergic reaction, usually manifested by hives or wheezing, a medication can usually be given safely in the future (again, do NOT do this on your own!)

#5 If you’re allergic, but can tolerate “a little bit” of the allergic trigger, it’s good to keep taking that little bit

This one was new to me, but someone brought it up. The idea is that there may be some people who seem to be able to tolerate “a little bit” of their trigger, let’s say a little cheese, but has a belly ache if they consume a lot of milk. So maybe it’s OK for them to take that little bit.

No! First, you have to ask, is the patient really allergic? In my cheese example, the patient probably has lactose intolerance, not an allergy—so it’s fine to take some dairy, if it doesn’t hurt.

But in a truly allergic individual—one with true allergic symptoms—even consuming a little bit of the trigger is going to perpetuate the allergy and make it less likely to outgrow it. So if your child is really allergic, don’t cheat!

#6 People with any history of egg allergy shouldn’t get a flu shot

There is a tiny amount of egg protein left over from the manufacturing process of making influenza vaccines. If your child has a severe egg allergy, flu vaccines cannot be given; but for children with far-more-common mild reactions, flu vaccinations are safe and a good idea. If in doubt, egg allergy testing can be done, or the flu shot can be given at the allergist’s office.

#7 People with egg allergy shouldn’t get an MMR vaccine

This just isn’t true. It’s a myth. MMRs can safely be given to anyone with egg allergies.

#8 Allergy testing can tell you if a child is allergic to something

Hoo boy, pediatricians seem to miss this one! The way to know if a person is allergic is entirely in the history: do symptoms of allergy occur upon exposure? If they do, that’s allergy; if they don’t, that is not allergy. If the history is clear, the diagnosis is nailed, done, confirmed, and set. No tests are needed; in fact, tests are quite likely to confuse the picture.

Allergy tests are for when the history is not clear, to help separate exposures that are “likely” from “less likely”, so that further history can be explored and attempts at avoidance attempted to see what the response is. Allergy testing, either with blood tests or skin testing, is far too inaccurate to be used in any other way.

Be especially wary of web-based labs that promise extensive allergy testing to investigate vague symptoms like weight gain, abdominal pain, low energy, fatigue, and behavior problems. These symptoms are not caused by allergy, though fraudulent testing will inevitably lead to false positives and incitements to purchase detoxifying supplements. This is quackery, and expensive quackery at that. Stay away!

#9 Hives are usually caused by allergies to foods

In adults, this might be true; but in kids, hives are more often triggered by minor infections than by food exposures. Sure, if there are hives you ought to think about potential new foods, and if there is a correlation you ought to look into that. But in the majority of cases in pediatrics, isolated or even recurrent episodes of hives are not necessarily from food allergies.

#10 Specific allergies run in families

“Don’t give him penicillin! Mom’s allergic!” While the predisposition to allergies, asthma, and hay fever run in families, it isn’t to the same specific trigger. Junior has a mom with shrimp allergies? That means that he might more likely have food allergies of his own, but not more likely to shrimp than to peanut or egg or anything else. Same for medication allergies.

If your physician is telling you myths from the above list, it’s time to ask for a referral to an allergist to get the best information. If it’s an allergist tell you one of these myths, well, I’m stumped.

Nuts. Allergy!

Allison, whose name was ranked #47 among newborn girls in 2007, has a question about nut allergy: “We just (inadvertently) figured out that our 6 year old son is allergic to pecans. His reaction isn’t life threatening — his eyes swell up and get itchy. What should we do (other than obviously teach him to not eat pecans)? Do we need to get him tested officially? Tell the school? Anything else?”

The first step, as you said, is to avoid pecans: teach him not to eat them, and to ask adults about the nut contents of food, and get used to reading labels on things like cookies or brownies. Since he might not be able to tell the difference between a pecan and another nut by just looking, it’s probably best for him to learn not to eat anything that looks like a nut unless it’s OK’ed by you. Definitely, tell the school, tell grandma, and tell any of his friend’s parents before you drop him off for the afternoon.

You should also travel with Benadryl at all times, and keep some in your house. Make sure grandma has some too. Talk with your pediatrician about specific dosing and usage of medications, and whether you ought to carry injectable epinephrine. People at the highest risk for life-threatening nut allergies are those who have had any sort of nut reaction in the past and who have a history of asthma or wheezing.

Allergy testing can be useful to see if he’s also allergic to other tree nuts, or to peanuts (there are often cross-reactions.) If he’s already had peanuts and other kinds of nuts, and never reacted, there is no need for testing. But if you’re not sure if he’s had different kinds of nuts, it’s a good idea to do a “nut panel” to see if he’s likely to be allergic to other nuts.

Visit the Food Allergy & Anaphylaxis Network for more info—it’s an excellent, non-profit web resource with good info on nut and other food allergies.