Allergy Shmallergy

Simplifying life for families with food allergies.

IMPORTANT: EpiPen Recall April 1, 2017

IMG_3211Expanding on its recall in other countries, Mylan is now recalling EpiPens in the United States.

 

The recall began when reports of two devices outside of the U.S. failed to activate due to a potential defect in a supplier component.

 

According to Mylan, “The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). ”

 

As a precaution, Mylan is recalling EpiPens made my their manufacturer, Meridian Medical Technologies, between December 2015 and July 2016.  This recall applies to both their EpiPen Jr. dose (0.15mg) and their regular dose (0.3mg).   The recall does NOT affect generic EpiPens introduced in December 2016.

 

Please see below for lot numbers and expiration dates.  Remember to check any EpiPen sets you may have including those outside of your home (for example, at school, daycare or a relative’s house).  Mylan said that recalled EpiPens will be replaced at no cost to the consumer.

 

For more information as well as product replacement information, please visit Mylan’s site directly.

 

Mylan EpiPen recall April 2017*Please share widely with friends and family as well as school administrators and nurses.*

 

UPDATE:

If your EpiPens are affected by the recall:

  1.  Contact Stericycle to obtain a voucher code for a free, new replacement EpiPen.  Stericycle: 877-650-3494.  Stericycle will send you a pre-paid return package to ship back your recalled EpiPens.
  2. Bring your voucher information to your local pharmacy to receive your free replacement EpiPens.
  3. Send your recalled EpiPens back to Stericycle using their packaging.  Remember: DO NOT send back your recalled EpiPens until you have replacements in hand.

 

Mylan continues to update its recall page with their latest information at mylan.com/epipenrecall.

 

6 Tips for Traveling with Food Allergies March 7, 2017

pool-690034_1920 via pixabay

 

Spring break is on the horizon!  Can you smell the fresh air already?  Are you mentally packing your bags? (I am!)

 

Here are a few tips when traveling with food allergies:

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  1.  Call your airline and inquire about their food allergy policy in advance.  Ask specifically about early boarding and in-flight announcements.
  2. Most airlines will allow passengers to board the plane early in order to wipe down surfaces (this includes seat backs, seat belts, tray tables and knobs, armrests). Be sure to bring enough baby wipes or antibacterial wipes (such as Wet Ones) to cover all the legs of your travel.  Again, ask about pre-boarding at the gate.
  3. Carry your epinephrine auto-injectors and antihistamines ON BOARD.  Do not pack these away in your luggage.  [*ALLERGY SHMALLERGY TIP*: Zyrtec makes dissolvable tablets which eliminate the worry over bringing liquids through security as well as anything spilling in your bags.]
  4. If you’re traveling to a warm weather destination, you’ll need to remember to keep your epinephrine auto-injectors at room temperature – even while enjoying the beach or pool.  Pack a cool pack (like this one) and an insulated bag (like this cute lunch bag).  Store the cool packs in your hotel’s mini-fridge (who needs a $15 bag of M&Ms anyway!?) or plan on ordering a to-go cup of ice to keep the medicine cool poolside.
  5. A hotel or resort’s food services manager can usually help you navigate menus.  On our last vacation, the food services manager had food allergies himself and was invaluable in hunting down ingredients and safe alternatives for our family.  Befriend this fantastic person!
  6. If you’re planning on visiting an amusement park, taking a hike or being similarly active, consider packing a backpack into your luggage (or use one as your carry-on!).  You’ll need to bring your epinephrine auto-injectors wherever you go – especially on vacation when you’re away from home cooking, familiar restaurants and local knowledge of hospitals and doctors.  Backpacks can make carrying it easier depending on the activity – simply slip the insulated bag into your backpack and go!

 

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Two more notes:

  • Airline travelers should bring their own snacks/meals on board flights to ensure their safety.
  • Refrain from using airplane blankets and pillows as allergen residue may reside there.
  • Bring a baby or antibacterial wipe to the bathroom to wipe down door  and knob handles.

 

 

 

The Fire Drill – 5 Key Lessons from an Intensely Scary Night February 22, 2017

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I had been home from the restaurant only ten minutes with my preschooler almost tucked into bed when I got the call.

 

“Miles isn’t feeling well. He’s nauseous and is having terrible asthma. We’re heading home early,“ my husband informed me calmly. My husband and two sons left our regular sushi dinner to attend a tennis lesson, still chewing as they walked out the door.

 

My oldest son has suffered from asthma since he was 10 months old, but this just didn’t sound like the typical onset of asthma for him. Something about Eric’s voice suggested something “other.” “Do you think it could be a food allergy reaction?” I asked.

 

“I don’t know; but we’re getting home as quickly as possible.”

 

Completely abandoning my daughter in her bed, I walked to our emergency medication and unsheathed the freshest EpiPen. I was reviewing our emergency action plan as headlights tore into the driveway.

 

Calm but focused, I greeted my son at the door. He was red and hot and choking out words as I tried to check in with him about his symptoms. He could barely speak. He felt nauseous and clutched his stomach as he made his way into the bathroom, afraid he would throw up. His description of his symptoms came out in – sometimes inaudible – spurts. He was fighting for breath. He felt and looked worse than I had ever seen him.

 

While my hand calmly rubbed his back and my eyes scanned his face assessing the situation, a million thoughts raced through me in a nanosecond. Was it something he ate? Was he possibly reacting to a new allergen? Was this anaphylaxis or pure asthma…or both? The flu and other upper respiratory viruses were spreading so rampantly that nearly a third of my son’s class was out that week. And, he had mentioned having a headache and feeling a little nauseous after school – something that had seemingly subsided by dinner.

 

No matter how I weighed my options, a few small words reverberated in my brain: two systems. Most emergency action plans state that if two or more essential systems (gut/stomach, lungs, skin, heart) are affected in an allergic reaction, epinephrine should be administered immediately. I held up the auto-injectors behind my son’s back, signaling to my husband that we might need to use them. Neither of us have had to use an auto-injector on my son before (knock on everything wooden). We knew it was probably the right call now. We were both looking for the other to validate that decision.

 

As with all things, I wanted the use of the auto-injector to be the absolute right decision. I called my father-in-law, a doctor of more than 40 years, for one last vote on how to proceed. It was a brief conversation. “Get him breathing! Give him albuterol, I’m coming right over.”

 

Having caught sight of me waving the EpiPen in the air to my husband, my son had now begun to sweat with panic – making everything much worse. I sat him on the couch and tried to cool him off for just a moment – considering the facts again. Asthma. Nausea. No throat, mouth, or tongue swelling. No hives. No clear relationship between this reaction and food – but always a real possibility.

 

I looked at my sweet boy once again, suffering for breath, and noticed his pallor wasn’t quite as red any longer; it was now tingeing blue. I grabbed the epinephrine and pulled off the safety cap. At that very moment, my brother-in-law (another doctor) and father-in-law walked through the door. With stethoscope in hand and exuding a calm and caring in doses that make me tear up in appreciation even now, they examined my son and set him up on a nebulizer – a machine that delivers asthma and other respiratory medications as a penetrating, breathable mist.

 

We monitored Miles’ pulse (which was steady) and his breathing (which was labored and difficult). It took a lot of medication and effort, but Miles began processing air more efficiently. I didn’t realize until the second hour of treatment that I had been clutching his auto-injector the entire time.

 

As Miles’ color returned and the dust began to settle, he began to recall details about his day – clues that might have been helpful earlier. Like, the fact that he experienced asthma during recess at school. As he continued to improve, we noted that he was simultaneously experiencing a migraine, which can bring about nausea. Together, we determined that this was likely an acute asthma attack and not a result of his food allergies.

 

All four adults watched Miles for another several hours (well into the night) before anyone was willing to even entertain sleep. And, by then, sleep didn’t come so easily. I awoke in a gasping sweat several times that night and slipped into my son’s room to check on him. At around 5:45 am, I placed my hand on his back and he broke the quiet of the pre-dawn, humorously stating, “Mommy. Your hand is like a furnace!” Smiling and with great relief, I knew the sun would come up that morning and all would be well.

When I relayed these events to my own father, he captured it perfectly. “You had a fire drill last night.” We certainly did. And, as with any good training exercise (intentional or not), we learned some valuable lessons that night.

 

  1. Trust your instincts. I knew we needed to use epinephrine. Had there not been two doctors in the family within arms’ distance from me, I would have absolutely used it. And, so would my husband. Even though it was not anaphylaxis and everything turned out well, I STILL regret not having used the auto-injector sooner. I had my doubts about a food allergy reaction for a number of reasons. The afternoon nausea as well as the absence of hives and swelling gave me pause – which is why I called my father-in-law. But, did being right about his diagnosis make me feel better about my hesitation? No. Severe food allergic reactions can present themselves with a number of symptoms and they can escalate very quickly.

 

  1. Always, ALWAYS carry your epinephrine auto-injector with you. EVERY TIME. And, make sure that your friends, family and/or whoever is caring for your child knows how to use it (procedures are slightly different for Auvi-Q, the Adrenaclick and the EpiPen, so I recommend reviewing often). In our case, we accidentally forgot to transfer the auto-injectors from my purse to my husband’s bag, taking for granted that he’d no longer be around food; out only for an hour to play tennis. Thankfully, we live two minutes from the tennis courts. But had they been further, my husband would ABSOLUTELY have needed those auto-injectors.

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  1. As if you needed an extra reason to carry your auto-injectors: Those who have asthma are more likely to suffer from severe food allergic reactions– particularly if that asthma is not well-controlled. Asthma can complicate food allergies. Asthma occurs when there is narrowing of the airways, making it difficult for an individual to take in the proper amount of air. In my son’s case, his lungs were taking in so little air that initially my father-in-law couldn’t hear any movement with his stethoscope. No wonder he was turning blue. In an emergency situation, epinephrine can be used to treat a severe asthma attack. We were milliseconds from using it.

 

  1. If you use an epinephrine auto-injector you must go the nearest emergency room immediately. This is not because you gave the injection. Rather, those having severe food allergic reactions need additional medication and treatment. Furthermore, patients can suffer something call a bi-phasic reaction – that is, a second, delayed bout of anaphylaxis. It is estimated that up to 20% of patients suffer such a reaction.

 

  1. Once Miles went to sleep, we recapped the night with my father-in-law, who’s served in some fast-paced emergency rooms. I’ve been repeating something he said that night to everyone who will listen:

“We used to tell surgical residents,” he began, “‘If you’re considering performing a tracheotomy, then you need to do a tracheotomy.’”  The same holds true for anaphylaxis. If you think you might need to use an auto-injector, then you DO need to use one. If you’re considering it, then the time is now.

 

I’m beyond grateful that our story ends happily.  I pray you all never have to experience the intensity of a severe reaction (whether that be from food allergies or acute asthma).  But I hope that by sharing our experience and the lessons we learned, your story will end happily, too.

 


 

Essential Resource:

I can’t recommend enough this informative piece on when to give what medication during a severe allergic reaction. The information contained in this article echoed in my head during the above incident.

 

From the Food Allergy Treatment Talk blog:

Putting the Fire by Dr. Brian Schroer

 

Auvi-Q’s Returning to Market With an Innovative New Approach January 23, 2017

Oh, happy day!

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Auvi-Q is coming back to market on February 14, 2017!

As many of you already know, Auvi-Q is an innovative, FDA-approved epinephrine auto-injector that is about the size of a deck of cards.  Auvi-Q was invented by twin brothers, Eric and Evan Edwards, who suffered from severe, life-threatening food allergies as children. Eric Edwards, an MD, and Evan Edwards, an engineer, teamed up as adults to invent this unique and effective life-saving device.

 

This product has a very valuable place on the market:

  • It fits in your pocket – making a great choices for dads, preteens and teens;
  • It speaks the instructions, step-by-step – reducing the worry over training and operation;
  • Auvi-Q’s needle retracts immediately after injection, mitigating the possibility of lacerations and making it safe to handle.

 

But that’s not even the best part.  Not only are Eric and Evan patients, they’re also food allergy parents who understand the needs of our community from a unique, first-hand perspective.  After speaking to patients and considering their own family’s needs, they wanted to ensure all families had access to and could afford their product.  So they are introducing AffordAbility, a first-of-its-kind program under which the vast majority of patients (including those with high deductibles) can obtain Auvi-Q for $0.  And, not only will the product be free for so many patients, but Auvi-Q will also be available for direct-delivery to your home (in most cases, in less than 48 hours in insulated packaging).

 

The makers of Auvi-Q, kaléo Pharma, wanted to remove as many of the barriers families face in order to ensure that the patients who needed this life-saving medication would be able to obtain it.  No family should have fear they are unprepared to help in a life-or-death severe allergic reaction such as anaphylaxis.

 

The Auvi-Q website is a wealth of information: Auvi-Q.com.  Please refer to it for further questions the device, prescription, the AffordAbility program, and direct delivery service.

 

 

 

Managing Food Allergies In the Snow November 30, 2016

winter sledding in the snow, winter break

photo taken by Kevin Jarrett

Winter is an important time to get outside. It leaves you feeling refreshed and invigorated. Winter weather invites us to engage in all kinds of fun and unique activities. Ice skating and hot chocolate go hand in hand. Snow days beg for sledding down sleek hills. Cross-country skiing, snow shoeing, and even hiking are fabulous ways to appreciate the quiet beauty of the season.

 

And, of course, there’s my personal passion: skiing.

 

No matter what your winter passion is, please read Let It Snow! (below) for some important tips on how to carry your epinephrine auto-injector and how to manage your food allergies in the cold and on the slopes!

 

See our story and read how to enjoy – not endure – the season in the Winter 2016 edition of Allergy & Asthma Today:

 

Allergy & Asthma Today – Winter 2016

Or read it here:

Let It Snow!  Managing Food Allergies In the Snow

Our family loves wintertime and winter sports – skiing, sledding, ice skating, you name it. My son has multiple food allergies, so we always carry epinephrine auto-injectors with us, even in the cold, and we make sure they are safe and secure.

 

Epinephrine must be kept at room temperature in order for the medication to remain effective. When you plan to go outside in the cold, carry your auto-injectors in the inside pocket of your winter coat.

 

If you have no interior pockets, or they’re not big enough, get creative. We made a holder for our epinephrine auto-injectors using a pencil case and a lanyard – anything to keep the epinephrine close by and at the correct temperature.

 

Gone Skiing

 

When my son was old enough, my husband – an avid skier – was excited to get him on the slopes. But the idea of trying to manage his food allergies on a ski vacation seemed challenging.

 

Who could I track down to get ingredient information for food in the ski lodge cafeteria? How was I going to store and easily access snacks and lunches that were safe for my son? Could I rely on the ski school to look out for him and his food allergies?

 

During recent ski trips, we found food service employees were knowledgeable about food allergies. Several of my son’s ski instructors needed no introduction to epinephrine auto-injectors – some had food allergies themselves, which made them even cooler in my son’s eyes.

 

The staff walked him through cafeteria lines, read ingredient lists, and helped him find safe alternatives for group snacks – all at 10,000 feet.

 

If you’re planning a trip to a ski resort, here are some food allergy tips:

 

  1. Call ahead. Ski lodge operations may seem relaxed, but they do take food allergies seriously. We spoke with a food services manager at one ski lodge who outlined their offerings, looked up food suppliers and tracked down ingredients for us – all before we stepped foot in the snow. Ask about the lunch routine during ski school and what kinds of food students receive. Are they given snacks? Do they have free choice in the cafeteria?

 

  1. Show up for ski school classes early with your epinephrine auto-injectors. Talk with your child’s ski instructors and if necessary, teach them how to use an epinephrine auto-injector – and when to use it. Remind them they will need to store it in an inside pocket of their ski jacket to keep it close to room temperature.

 

  1. Consider meeting up with your child’s ski school class for lunch to help your child navigate the cafeteria line. But don’t expect to eat with them! Skiing creates fast friendships and your child will have more fun hanging out with their ski buddies.

 

  1. Pack some safe snacks and store them someplace readily accessible. Kids are often hungry when they get off the slopes and ski lodge cafeterias typically close right when the lifts do.

 

Now … Bring on the snow!

 

 

Breathing Easy On the Slopes

 

Many people with food allergies also have asthma. When outside in wintertime, cold, dry air can be an asthma trigger. Wrapping a scarf around your nose and mouth warms the air you breathe and helps keep the rest of you warm as well. Tuck a quick-relief bronchodilator inhaler into an inside pocket of your jacket just in case you start to cough or wheeze.

Food Allergies

Enjoying a fantastic winter vacation. Skiing in Park City, Utah.

 

Motivations: Dr. Douglas McMahon, Doctor, Inventor and Entrepreneur October 4, 2016

Filed under: Preparedness — malawer @ 7:30 pm

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Dr. Doug McMahon is more than your average allergist.  His out of the box thinking led him to create an affordable epinephrine auto-injector whose practical design could save lives. His device, named AllergyStop, is a palm-sized auto-injector – small enough to attach to a key chain.  Read about his journey below: what led him into allergy and immunology; the inspiration for his invention; and how you can follow the process of getting AllergyStop to market.

 

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1.  What led you to become an allergist?  Did you feel a connection to the field?

When I was very young I had food allergies, environmental allergies and asthma.  I was under the care of various doctors who said that  I should be home schooled, shouldn’t play sports or go to friends houses.  My mother knew that there were many other kids in my situation living a normal life so we found a specialist to work with and I lived a ‘normal life’.  This impact made me want to become a doctor and an Allergy specialist in particular.

2.  Have you experienced an allergic reaction yourself?  Anaphylaxis?
Yes, I have had a few significant reactions.  Thankfully no anaphylaxis in the last 25 years.  Most of the severe anaphylactic reactions were when I was very young and they didn’t know yet I was allergic to tree nuts.
3.  What led you to develop AllergyStop?  Describe your “Aha!” moment.
When I was in high school and realized I needed to start carrying this bulky device everywhere. I took apart my EpiPen and realized it didn’t need to be so big.  I started playing around with parts over the years and when I became a doctor I realized the small amount of epinephrine needed.  I was busy in medical school but still toyed around with it.  In residency, I learned how inexpensive the medicine and parts were so I started building prototypes.  AllergyStop is the best one I developed that is efficient, compact and inexpensive.  We will be working on other improvements on the device through the years.
4.  How does AllergyStop differ from current epinephrine auto-injectors?
It is more compact and you can have an adjustable needle as some patients are too big for the EpiPen needle length and it does not go intramuscular as intended.  Some are too thin and it goes into the bone.  AllergyStop has resolved this issue.
5.  Where does the product stand now?
We have a functional prototype that I currently carry on my keychain.  We have a patent pending and are finalizing the patent.  We are contracting with manufacturers that will make the device and fill with epinephrine and have a few bids in right now.  Once secure we have an outline of the regulation tests required by the FDA and then we will submit to the FDA ‘fast track’ via 505 b2.
6.  What hurdles remain to overcome?  How can those interested stay informed on its progress?
Hurdles include the money for the testing that is estimated at upwards of $3 million.  The problem is that venture capitalists are interested but they often expect a large return on their money and would want AllergyStop’s price to increase.  We want to keep the cost affordable for patients.
7.  How has your experience both having food allergies and developing AllergyStop changed/enhanced your relationship with your patients?
I can relate well to my patients that have had reactions and have the burdens of watching what they eat.  I think it makes the patients more appreciative and comfortable.  It’s actually tough to see some of them wanting my device now and yet the FDA advises against giving it out without all of the regulatory steps.  Hopefully soon.

 


If you want to help support the process of getting AllergyStop to market, please visit AllergyStop’s IndieGoGo page.

 

 

The High Cost of High Prices: EpiPens’ Real Cost to Families August 25, 2016

Filed under: Advocacy,Preparedness — malawer @ 9:12 am

With all the talk about rising cost of EpiPens, it’s important to remember who this situation impacts the most.  At-risk and food insecure families.  There has been a lot of media attention recently focused on the price of EpiPens, but these families, who are already living paycheck to paycheck, have been bearing the burden of added anxiety over whether they can afford the only life-saving medication available for their children for years.  Add in what I most recently learned about the limitations of some ambulances to carry and use epinephrine and there may be a healthcare superstorm brewing on the horizon.


 

By way of background…

 

It’s all over the news:  EpiPen prices have climbed over 400% in the last 10 years, making this one and only lifesaving drug nearly – if not completely – unaffordable for many families.  Ten years ago, a pair of EpiPens cost between $75 and $100.  Today, they are sold for $600-700.  Understanding that families need multiple sets (for school, aftercare programs, home and on-the-go), the financial burden becomes even greater.

 

While there may be programs that do benefit families with certain kinds of healthcare plans and help mitigate the cost of EpiPens, there are a significant number of families who are struggling to justify the cost of this medication.  These aren’t always low income families, some are typical middle class families who earn just enough to take care of their current needs.  The rising cost of EpiPens is tipping that delicate balance unfavorably.

 

As EpiPen prices soar, so does the cost of NOT carrying them.

 

Given the high cost of EpiPens coupled with their relatively short shelf life, families are being forced to make a difficult choice.  And some are choosing to forego filling their prescriptions. More and more, families whose finances are stretched thin are relying on emergency responders as their first line of defense should a severe allergic reaction occur.  They are operating without a safety net and hoping that emergency medical care will catch them.

 

But what do you do if the ambulance you’re waiting for isn’t carrying epinephrine?  What if the EMT that arrives isn’t authorized to administer it?

 

This is the case in many cities and counties across the United States.  The ability to carry epinephrine as well as the local protocols authorizing EMTs to administer it vary from place to place. [Please read: Does Your Ambulance Carry Epinephrine?]

 

This collision of high EpiPen costs and the inconsistent ability of emergency responders to help may cause a far larger problem.  Already low income families* pay 2.5 times more per year on emergency room visits and hospital care than higher earning families.  And, in a 2013 study conducted by FARE, results showed that when people suffering from anaphylaxis used emergency care, epinephrine was not usually used to treat their condition.  It appeared to the researchers that even seasoned emergency medical professionals were reluctant to use epinephrine – despite the fact that it is known to be a safe drug with few short-term side effects.

 

In FARE’s study, 58% of those who called 911 administered epinephrine before an ambulance arrived.  In a life-threatening situation when every second counts, what will happen if more cases of anaphylaxis arrive at the emergency room without having received epinephrine on scene OR en route?  It appears many will also not receive it in the emergency room either.

 

How will lower-paying municipalities compete with higher paying counties and cities to retain competent, capable paramedics and advanced EMTs (those most often allowed to administer epinephrine)?

 

What role does cost play in local government decision-making regarding whether or not to stock ambulances with EpiPens and who has the authority to administer them?

 

These are only some of the unanswered questions that are starting to boil to the surface.   I hope Mylan’s expanded efforts to get EpiPens in more hands helps some of these at risk families.   But I remain concerned that the confluence of high prices and inconsistent policies governing emergency medical use of epinephrine will continue to cause a ripple effect across the healthcare spectrum.  I just hope it remains a ripple and not a tidal wave.


 

* A study, co-authored by Dr. Richi Gupta, published in Pediatrics defined low income families as those earning less than $50,000 per year.