Allergy Shmallergy

Simplifying life for families with food allergies.

Needle-Free Epinephrine May Soon Be a Reality October 15, 2019

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By now, we all know that epinephrine is the first – and best – line of defense against a severe food allergy reaction called anaphylaxis.  But when symptoms of anaphylaxis first appear, many patients and caregivers hesitate to give it.  Why?

 

Not only are patients unsure about the timing to deliver a dose of the life-saving medication, but they tend to pause at the idea of giving an injection.  Parents worry that it will be difficult to administer or that it will scare/hurt their children. And, patients are at risk for minor injuries associated with delivery such as lacerations and misfirings.  Doctors and clinicians say epinephrine auto-injectors are “underused” in an emergency.  Delays in administration of epinephrine during anaphylaxis put the patient at risk for a more severe reaction that could require more medication to stabilize.

 

To date, patients have had a single option for getting a dose of epinephrine: an injection given to the patient through the outer, muscular part of the thigh.  But the food allergy community has long wondered, is there another way?

 

Enter: intranasal epinephrine.  

Essentially: epinephrine delivered through a nasal spray.

 

Researchers have examined how well the body absorbs epinephrine when it is given intranasally as compared to intramuscular injection (the way epinephrine is currently administered through auto-injectors).  What they found surprised us all:  epinephrine can be absorbed and distributed throughout the body as a nasal spray just as well as it would an injection.

 

This is wonderful news for patients and caregivers that are afraid of needles.  But it’s also good news for those wanting to help in an emergency.  Because nasal sprays are a less invasive treatment, patients and caregivers may find themselves more likely to act quickly, administering much-needed epinephrine sooner and more frequently than they would otherwise.  Nasal sprays could make acting in those first critical minutes of anaphylaxis easier which could make follow-on emergency treatment less complicated and would ultimately save lives.

 

A few pharmaceutical companies have begun developing intranasal epinephrine products.  One such company is Bryn Pharma which developed a portable, easy-to-use spray (currently referred to as BRYN-NDS1C). BRYN-NDS1C was granted Fast Track Designation by the FDA and is currently undergoing human trials.  Bryn’s nasal delivery device has already been approved for use in other conditions by the FDA.

 

Another company, ARS Pharmaceuticals, whose product is called ARS-1, was also given Fast Track Designation to develop intranasal epinephrine.

 

Studies and trials continue, while questions remain about the efficacy of this delivery system when a patient experiences such factors as nasal/sinus swelling or moderate to severe congestion.

 

Although final approval by the FDA and ultimate delivery of this medication to customers is still unknown, we should all have high hopes for more and innovative epinephrine options to consider in the future.

 

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What Food Allergy Kids are Wondering October 3, 2019

Filed under: Social and Psychological Issues — malawer @ 2:15 pm

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I just returned home from the ever-impressive FACES conference in Chicago. This wonderful conference puts patients and caregivers in the room with researchers, physicians, psychologists, counselors, advocates and experts who lead them in discussions about the present and future of food allergy.  It is a fascinating, energizing, and supportive event.

 

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I learned so much over the course of my FACES experience, but one session stands out.  Throughout the day, any attendee – child or adult – could put a question in a box that would be read anonymously and answered during a session, titled, “FACEless, What Do You Want Your Parents to Know?  What Do You Want Your Kids to Know?”

 

The information gained from this session was enlightening – and it wasn’t just the answers (however incredibly informative) that interested me most.  It was the kinds of  concerns on our children’s minds that truly stood out.

 

Do you trust us when we’re out with our friends?

Are my food allergies a burden to you?

Do my food allergies scare you?

What worries you the most about my food allergies?

 

In addition to managing their own concerns and regulating their own emotions, some food allergic children are worried about how their parents are coping.  This is an additional weight they carry on top of the demands food allergies naturally come with.

 

Food allergies have been cited to lower the quality of life for patients, increasing incidences of:

  • anxiety
  • stress
  • depression
  • social isolation

 

At the root of this emotional strain is the hardship of food allergy management.  Patients are saddled with many additional responsibilities – often beginning at a young age.  They must understand where risk exists, how to react in an almost-inevitable emergency, cope with feelings of insecurity and fear and they bear the obligation of educating others, communicating their condition and remaining firm in the face of misunderstanding or objection.

 

How do we address these silent concerns our children may carry with them?  

 

How can we allay their worries so they can concentrate on the busy work of childhood and adolescence?

 

 

Talk the talk and walk the walk:

 

  • Demonstrating a can-do attitude and verbalizing problem solving can be very empowering.

 

  • Model positivity and embrace the values and guiding principles that are important in your lives (kindness, inclusion, empathy, etc).

 

  • Validate the emotions patients are experiencing and discuss productive ways to manage uncomfortable feelings.

 

  • Involve kids and adolescents in overcoming obstacles.  Teamwork and supportive coordination is critical to security and well-being.

 

  • When it comes to the sensitive conversations about how you (the caregiver) are coping, model healthy emotional management and focus on your love for the patient.  It’s okay to acknowledge your feelings with your children – it shows you’re human.  Be sure to also show them your resilience.  Talk about how you handle these feelings and ask them what they do when they feel overwhelmed or insecure. Talking about how you feel encourages your children to be honest about their real feelings and experiences.

 

  • Let negative emotions help motivate you in positive ways.  Focus on the outcomes you’d like to see.  An example conversation might begin, “When you leave the house without your auto-injectors, I do get worried you’ll be unprepared for a reaction. I never want you to feel sick and be caught without your medicine. Let’s come up with a way I can help you remember and find an easy way to carry it.”

 

  • IMPORTANTLY, reassure your children that you will do everything you can to keep them safe and take care of them.  Make sure they know they can talk through future food allergy anxiety and challenges with you.  Reinforce that you are right there with them, partnering with them to overcome any obstacles in their way.

 

The FACES conference was so incredible and this session will sit with me for a very long time.

 

For more information about the psychological side of food allergies, please read:

Parenting Positively in the Face of Food Allergies

Identifying and Recognizing Emotions

Managing Food Allergy Anxiety

 

 

 

FDA Review of Aimmune Peanut Therapy September 13, 2019

 

 

 

I was so honored to be chosen as a speaker at the US Food & Drug Administration’s (FDA) Allergenic Products Advisory Committee (APAC) meeting (September 13, 2019).  The purpose of this groundbreaking hearing was for the APAC to have a discussion and make recommendations to the FDA on the safety and efficacy of Aimmune’s AR101 peanut allergy treatment at reducing the risk of severe allergic reaction (anaphylaxis) after accidental and unintended exposure in children and teens with peanut allergy.

 

Representatives of major food allergy non-profits, knowledgable doctors with deep experience with desensitization, experts in psychology, the underserved population, patient advocacy as well as affected families offered an honest and complete picture of the lives and challenges of living with food allergies to the APAC panel.  Testimony focused on quality of life, psychosocial impact of food allergy, daily challenges, and unmet needs.  Discussion also centered on medical guidance, patient choice in regards to risk/benefit of AR101, and education as it relates to AR101 therapy.

 

It is my hope that the committee approves this treatment.

 

Until now, food allergy families have had only one management option: avoidance.  If the FDA approves AR101, it will standardize dosage, treatment protocol and, hopefully, increase its accessibility.  AR101’s approval could pave the way for more treatment options down the road.

 

APAC has recommended AR101 for approval.  Stay tuned for the full-FDA update.  Approval expected January 2020.

 

Here is the testimony I gave today:


Erin Malawer

Executive Director, AllergyStrong 

 

Food allergies are a challenge that affect both the physical safety as well as mental health of patients and caregivers.  Bringing AR101 (Palforzia) to market as a treatment option has the potential to greatly improve quality of life for these families.

 

What is the experience of having food allergies for patients?  In the words of my 14 year old son, “it’s a second, full-time job.”  And it starts the moment patients wake up beginning with:

  • The toothpaste they use to brush their teeth;
  • The sunscreen they wear;
  • The laundry detergent they wash their clothes with; and
  • The lip balm wear when I kiss my son goodnight.

 

Everything is a risk.

 

And, then there’s the FOOD!  Meals, snacks at school, the baseball stadium, the movie theater.  Patients must be knowledgeable about ingredients; how and where food is prepared and processed; as well as how to communicate and educate others about their condition.  The burden falls on families and caregivers to prepare safe food for holidays, school celebrations, birthday parties, field trips, and travel.

 

The thought and preparation is endless.  Food allergies are always on our minds.

 

Anything misread, any small misstep could potentially endanger a patient’s life.

 

 

The solution we’ve been given to keep him safe is simple, but daunting:  Avoid.

 

In order to do that effectively, each patient and their caregivers must understand both the seriousness of food allergies and the risks of cross-contamination.   But, we also need to be intimately familiar with labeling laws and loopholes as well as manufacturing practices. 

 

That keeps my child relatively safe at home.  But what about when he – and millions of other allergic children – step outside and navigate the real world?

 

Avoidance is challenging – it relies on the understanding of others – who are less experienced – for our health and safety.  Avoidance is cumbersome – labeling laws are incomplete, manufacturers aren’t always forthcoming and decision-making, even at its best, is difficult.  Avoidance accepts food allergies and all the associated worry, guilt, and burden as a life sentence and – because we all make mistakes – it accepts reactions as an inevitable. 

 

From an early age, my son understood these risks.  He has lived under the stress and reality that the next meal could cost him his life. 

 

At age 8, my son educated his own grandparents on what it’s like to live with food allergies.  “Grandpa,” he said, “I can’t be careful 75 percent of the time.  I need to be perfect 100 percent of the time.”

 

AR101 has the potential to change that.  If only he could have undergone treatment to lessen that incredible emotional burden.  AR101 (Palforzia) has the potential to make childhood easier for food allergy families.

 

Food allergic children and caregivers often struggle with anxiety, depression, and social isolation.  Many children experience bullying at the hands of peers as well as adults. 

 

In desperation, families are sometimes driven to turn to unregulated alternative treatments that leave them vulnerable and at risk.  Allowing for well-studied, standardized, accessible food allergy treatment outlines an established course of action for those looking for help.

 

AR101 (Palforzia) would be life changing for patients.  It offers much-needed hope for food allergic families; relieves mental strain on the patient as well as caregivers; allows room for inevitable error; and it dampens accidental exposure and threat of severe reactions.

 

It could specifically be transformative for patients in underserved communities where food allergy resources are often lacking, where emergency room visits are more common, and where reliance on those outside the food allergy community is necessary. 

 

I’d like to end by saying, at the present time my own child is ineligible for this treatment.  No matter what the outcome is today, he will continue to live under the specter of food allergies.  But professionally, I must advocate for patients who lives can be improved by AR101 (Palforzia) and the possibility of leading a more normal life. 

 

With this treatment, it may be possible for food allergy families to thrive and not merely survive.


 

 

 

“Spell It Out” PSA – The ABCs of Food Allergies September 10, 2019

Food allergies are a life-threatening condition that know no race, gender or economic status.  However, lack of awareness, education and preparedness are disproportionately affecting underserved families and communities where there is a higher percentage of dangerous reactions as well as higher costs of emergency care.

 

Filmed at a school that serves this population using real students with food allergies, “Spell It Out” is a public service announcement aimed at school children and their caregivers that addresses several key concepts about food allergies that are often misunderstood:

 

  1. Food allergies are real.  

Food allergies can be serious and life-threatening – different from a food intolerance which is an uncomfortable digestive condition but not life-threatening.

 

  1. Anyone can be allergic to any food at any age.

Food allergies are not simply a passing childhood condition. In fact, recent findings tell us that 1 in every 10 adults have food allergies, too.  And, despite their reputation, peanuts are not the only food to cause a serious reaction – you can be allergic to almost any food.

 

  1. Food allergies should be monitored by a doctor.

If you experience symptoms after eating, it’s important to talk to a doctor or nurse.  They can confirm a diagnosis, teach patients how to manage their food allergy, and help them get epinephrine – the only medicine capable of slowing or stopping a life-threatening reaction.

 

“Spell it Out” comes straight from the thoughtful and generous heart of Sammi Mendenhall, an Emmy-nominated producer who admits to being “that person who demanded peanuts on airplanes.” But after seeing the tragic story of Elijah Silvera on the news, she knew she had to learn more and educate others like herself.  She envisioned a project that could help and give a voice to those most at risk.  This project is a result of an amazing collaboration between several powerful advocacy organizations: End Allergies Together, AllergyStrong, Change for Kids, Elijah’s Echo, Natalie Giorgi Sunshine Foundation and Red Sneakers for Oakley.

 

Please visit spellitoutpsa.org for more information.

 

Feel free to share “Spell It Out” with your school – and contact us if you’d like information about an educational school visit for AllergyStrong or one of our outstanding partners.

 

Open Sesame: Prevalence of Sesame Seed Allergy & Progress in Labeling August 22, 2019

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If you have a sesame allergy, you know how hard it can be to determine whether a food is safe for you or not.  [Read here for more information on the challenges of living with a sesame seed allergy:  Sesame: The 9th Food Allergen?]. Patients and caregivers need more transparency and advocates have been asking the government for this change for years.

 

Last year, the U.S. Food and Drug Administration finally listened and requested additional information to evaluate whether to require food manufacturers to include sesame seeds (and its derivatives) on their ingredient labels.

 

In response, researcher Dr. Ruchi Gupta, Christopher Warren, Avneet Chadha, Jialing Jiang, and Dr. Scott Sicherer got to work figuring out how prevalent a sesame allergy really is.

 

Warren, Chadha and Sicherer revealed that 0.49% of the total US population are allergic to sesame seeds and its derivatives – more than doubling previous estimates.  This equates to approximately 1.6 million patients in the U.S. alone.  This means, more people are allergic to sesame than some tree nuts – for which the FDA currently requires labeling.

 

Their research also found that:

  • 1 in 4 patients developed their sesame allergy as adults
  • Sesame allergies tend to co-occur with other food allergies:
    • Half with sesame allergy are also allergic to peanuts
    • 1/3 also allergic to tree nuts
    • 1/4 also allergic to eggs
    • 1/5 also allergic to dairy

Furthermore, reactions to sesame tend to be more severe.  In fact, sesame is one of the top three allergens for which doctors prescribe epinephrine auto-injectors.

[For a look at the original study by Dr. Ruchi Gupta, Christoper Warren, PhD; Avneet Chadha; Dr. Scott Sicherer, et al, please see Prevalence and Severity of Sesame Allergy in the United States.]

What’s being done to include sesame on food labels?

A lot, actually.

 

First, the FASTER Act (H.R. 2117).  FASTER, which stands for Food Allergy Safety, Treatment, Education and Research, is a federal bill which includes improving the health and safety of those living with food allergies. The bill covers a wide variety of things including adding sesame to the list of food manufacturers must label properly for.  The FASTER Act was introduced to Congress in April 2019.

 

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Thanks to the amazing efforts of State Representative Jonathan Carroll, Illinois is now the first state to require sesame labeling on all foods just as they would under the federal law FALCPA.  Rep. Carroll hopes that law HB2123, now Public Act 101-0129 (July 26, 2019), will inspire other states to follow Illinois’ lead in protecting its citizens with food allergies.  Illinois is doing a lot of things RIGHT for their residents with food allergies!

 

So what can YOU do to help get sesame labeled under the Food Allergen Label and Consumer Protection Act (FALCPA)?

 

Right now, representatives are back home hearing from constituents.  Now is a great time to contact your local congressman or woman and encourage them to support the FASTER Act (H.R. 2117).

  • Tell them about the challenges of living with a sesame allergy.
  • Let your representatives know that the U.S. is one of the only industrialized nations that does NOT label for sesame at present.  The EU, UK, Australia and Canada already include sesame seeds on their labels.
  • Ask them to consider sponsoring a state bill, like the one in Illinois – this is how the stock epinephrine program became so successful.

 

And, please leave a comment below so that others can benefit from your experience advocating and listening to your local representatives as they speak to theirs.

 

 

Crafting a Comprehensive Food Allergy Policy at School July 23, 2019

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Across the country, schools create and reshape policies to balance the needs of their many students.  Every school should – but so often don’t – have a food allergy policy.  This policy should protect students with life-threatening food allergies – and it should be noted that although peanut allergies tend to provoke some of the most severe reactions, an allergy to ANY food can turn deadly. [Read about other allergic reactions here and here, for example.]

 

A food allergy policy is critical to give parents and their food allergic students guidelines about what to expect while their children are at school.  In addition, policies surrounding food allergies allow parents to prepare their children to safely manage their allergies in their school’s setting and gives parents and teachers time to prepare anything they need to keep their student both safe and included at school.

 

Where should schools begin?  And what should schools consider as they think of updating their current policy?

 

Some factors schools may wish to consider when formulating an inclusive food allergy policy and procedures:

 

  1. Creating a culture of inclusion and empathy:  What kinds of lessons are students receiving as part of their social-emotional learning?  What kinds of messages are students taking away from role models?  Does the behavior they see match the kindness and inclusion the school expects?  Read Including Food Allergic Students at School to review the many simple ways to begin the process.
  2. How and where to store epinephrine: Is the nurse’s office centrally located or would it be wise to also store epinephrine with a trained administrator closer to a lunchroom or classrooms?
  3. Keeping stock or unassigned epinephrine: In many states, schools are allowed to store epinephrine auto-injectors that are not prescribed to a particular student.  These stock epinephrine auto-injectors may be used with anyone who experiences a severe allergic reaction.  In a nationwide study, stock epinephrine is used in 38 percent of reactions that happen at school. That means approximately 30% of reactions happen to students and staff without a known allergy.
  4. Nursing schedules and availability: Who is trained to recognize the signs of a food allergy reaction? Do they know what to do in an emergency?  If the nurse is unavailable, who is responsible for handling this kind of crisis? Severe allergic reactions (called Anaphylaxis) are extremely serious and require IMMEDIATE attention.
  5. Hand washing:  Hand sanitizer does not remove food protein.  So actual hand washing is required when handling a student’s allergen to prevent cross-contamination. When and where should teachers enforce this habit?
  6. Communication with parents: Families of food allergic students need advance notice to make alternative arrangements for their children.  Schools benefit from this type of forethought as well.  For example, an upcoming in-school event which appeared to a teacher to be a problem for my food allergic son, turned out to be easy to manage with a few easy tweaks to the plan after we discussed the details involved.
  7. Availability of food storage space (for food allergy-friendly snacks and treats): whether the school supplies allergy-friendly snacks or families send them in, deciding where to store them for convenience and how to label them so that they are easy to identify is helpful.
  8. Field trip protocol: How will epinephrine accompany a student when he/she is off school grounds?  Who is trained to recognize symptoms of an allergic reaction and know what to do in such an emergency?
  9. The bus ride:  Are the students allowed to eat on the bus?  Do they anyway?  Is the bus driver prepared or trained to administer epinephrine if needed? Are students allowed to carry their own medication on the bus?  Is this feasible for your students based on age, maturity, income level, etc (epinephrine auto-injectors are costly in some cases)?
  10. Classroom events:  birthdays, celebrations, holidays, and special events.  Specific guidelines for what is and is not allowed must be set as well as strict adherence to the policy established. Food allergies are NOT a preference. They can result in hospitalization in a matter of minutes.
  11. Nut bans: Worthy of a separate article and discussion, schools need to weigh the burden/reward of banning nuts entirely.  And they need to discuss the extent of the restrictions (will it extend to cross-contamination warnings like, “made in a factory with…”) and how to enforce them.

 

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Faculty and staff should be educated and re-educated about food allergies each year.  They must learn to recognize the signs of severe allergic reactions (called anaphylaxis) and what those symptoms might sound like in the words of a young child. They need to learn how to react to an allergic reaction.  Understanding the basics of cross-contamination and ingredient label reading, among other lessons, will help protect food allergic students in their classrooms.

 

Clear policies that are consistently enforced, as well as appropriate and reasonable accommodations,  will help teachers, administrators and students alike have a safe and fun school year.

 

Effects of Heat and Cold on Epinephrine Auto-Injectors June 24, 2019

It’s that time of year again!  Camp, beach time, days at the pool…    Does weather change how you carry your epinephrine?  It should.

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Available in auto-injectors, epinephrine is the only medicine available that will slow or stop the life-threatening symptoms of a severe allergic reaction, called anaphylaxis.  Because no one plans for an emergency and allergic reactions can be both variable and unpredictable, patients must carry two epinephrine auto-injectors  (EAIs) with them at all times.  Yes, even to the pool.

 

The Ideal Temperature

Epinephrine is temperature sensitive, making it a tricky accessory to carry in the summer and winter months.  To remain 100 percent effective, epinephrine must stay at room temperature (68-77 degrees Fahrenheit or 20-25 degrees Celsius). Short trips between 59 and 86 degrees Fahrenheit won’t harm the product, according to researchers.

 

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Effects of Heat

Research has shown that prolonged exposure to heat can degrade the strength of epinephrine.  And, constant heat resulted in bigger change in epinephrine.

 

 

Confusion

Although short-term exposures outside room temperature conditions are safe – researchers and doctors don’t often define what “short-term” means.  A few studies looked at “real world” temperature fluctuations, mentioning that little or no significant change in epinephrine was observed under these circumstances.  But, what constitutes “real world” and how many degrees outside of the ideal window (68-77 degrees Fahrenheit) is too high?

 

It IS, however, worth noting that keeping an EAI in the car is not a good idea as it often puts the auto-injector FAR outside that ideal room temperature and affects the quality and effectiveness of the epinephrine.  Temperatures inside parked cars even on a mild can soar well beyond 100 degrees in just a few minutes (read more here).  

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Effects of Cold

Recent studies have shown that epinephrine doesn’t appear to degrade if accidentally frozen.  However, if the medicine is kept below freezing, the epinephrine can freeze despite the fact that the auto-injector may still fire – making it useless in an emergency.

 

To Each Injector His Own

Each epinephrine auto-injector is constructed slightly differently.  Extreme heat or cold may not only affect the epinephrine – it might interfere with the mechanism that delivers this life-saving medicine.

 

Watch the effects of extreme heat and cold on EpiPens: please see Allergy Superheroes post, Epinephrine Abuse Experiments – it is very enlightening.

 

Discoloration

Many who carry EAIs point to the color of their epinephrine (shown in a little window on EpiPen brand EAIs) as a way to judge if it’s still potent or viable.  According to manufacturers and pharmaceutical companies, this method isn’t a sure bet.  If your epinephrine is discolored or cloudy, then it is no longer good.  However, if it appears clear, this does not necessarily mean it hasn’t degraded or otherwise expired.

Words to Carry By?

Don’t judge an auto-injector by it’s [lack of] color.  The best way to ensure your epinephrine auto-injector will work properly and at full strength is to keep it as close to room temperature as you can and within its expiration date if possible.

 

Do your best and get out there and enjoy the weather whatever it is!