Allergy Shmallergy

Simplifying life for families with food allergies.

FDA Issues New EpiPen Warning – November 2018 November 19, 2018

Filed under: Preparedness — malawer @ 8:45 am
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Before you head out of town for Thanksgiving, please be sure to check your EpiPens!

 

A new advisory issued by the FDA warns that some EpiPen Auto-Injectors may not slide of out the plastic carriers case easily.  The labels attached to some of the EpiPen 0.3mg and 0.15mg auto-injectors as well as the authorized generic versions of the same strengths may prevent the devices from easily slipping out of the protective carriers, making access to the auto-injectors difficult or impossible.

 

In a letter of explanation, Pfizer (the makers of Mylan’s EpiPens) notes that the labels may have been improperly applied during manufacturing.  In an emergency, this may make it hard for patients to get their auto-injectors out of the carrier tube, delaying administration of epinephrine.

 

*It is important to note that neither the medication (epinephrine) nor the auto-injector itself is affected by this warning.  Both the medication and the auto-injector will work properly once removed from the protective carrier case.*

 

If a patient has a device that does not slide out easily from the tube or a label that is not affixed properly, please contact Mylan Customer Relations at 800-796-9526.

 

For more information, please read the joint statement from Mylan and Pfizer here.

 

Carrying Epinephrine: Stunning Stats and Easy Solutions October 16, 2018

Filed under: Preparedness,teens — malawer @ 9:00 am
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epinephrine flickr

We all know that the best treatment for anaphylaxis, a severe life-threatening allergic reaction, is an immediate dose of epinephrine.  So, why then do patients not carry it?

 

Some patients do not have access to epinephrine.  Although the drug epinephrine itself is not expensive, the devices used to administer it can be very costly.  Sometimes prohibitively so.  Many are working to reduce the price families must pay at the pharmacy.  The makers of Auvi-Q, for example, are offering their product for free to those with commercial insurance (including those with high deductibles and for whom it is not covered) in an effort to get epinephrine in the hands of patients who need it [read more here].  A generic EpiPen has just been approved by the FDA to be introduced in the coming year.

 

Teens are a group known for their non-compliance in carrying epinephrine.  Teenagers, wired to take risks and extra concerned about fitting in with peers, are often found without epinephrine when they critically need it.  In an effort to be like everyone else,  they some times purposely leave their auto-injectors when socializing with friends.  Adolescents will also mentally minimize the perils of leaving their auto-injectors at home and/or not reading ingredient labels while basking in the potential benefits of acting and operating like their friends and not drawing attention to themselves – a dangerous combination.

 

An Alarming Study

 

Dr. Dave Stukus and his colleagues from Nationwide Children’s Hospital conducted a study  four years ago of patients and their caregivers being seen by an allergist at their clinic.  Among their patients at high risk, only 40% carried auto-injectors even though 60% knew that epinephrine should be carried with them at all times.  Nearly 50% of patients carried expired devices and of the 60% diagnosed with asthma (which could make an anaphylactic reaction even more serious) only 38% carried had epinephrine with them at their clinic visit.

 

But Adults Surely Know Better…

 

Nope.

 

Adults with food allergies fared no better.  A survey was conducted earlier this year (March – June 2018) of 597 people representing themselves and their children (a total of 917 patients).   While the majority of those questioned filled their prescriptions for epinephrine, almost half (45%) didn’t have their auto-injectors with them at the time of their most severe reaction.  Shockingly, 21% didn’t know how to use their epinephrine auto-injectors (EAIs).

 

#AlwaysCarryTwo

 

In the same 2018 study, fewer than 25% of patients or caregivers routinely carried multiple auto-injectors despite the advice that all patients carry at least two self-administering epinephrine auto-injectors.  Carrying two EAIs is critical in case one fails or a second dose is needed before emergency services arrives.

 

To Sum It Up

 

According to Dr. Stukus, there are several reasons for not carrying epinephrine:

  • inconvenience
  • cost
  • forgetfulness
  • complacency if a long time has passed between reactions
  • expiration of previous EAIs
  • lack of understanding that patients should carry two EAIs at all times

and, I would add

  • denial of severity of conditions and the reality of a reaction

 

Solutions

 

First, all patients need access to epinephrine.  Financial assistance is available!  If you need help affording an auto-injector, please consider savings programs offered by the various pharmaceutical companies.  The non-profit Kids with Food Allergies has an excellent article to help make EAIs more affordable,  What to Do if You Can’t Afford Epinephrine Auto Injectors.

 

Second, education about the difficulties and dangers of managing a severe allergic reaction without epinephrine is needed.  This begins in the doctor’s office.  Physicians should ask about how and how often patients carry their auto-injectors and discuss best practices to make carrying two EAIs a habit.  In between visits, patients can learn how to properly use an epinephrine auto-injector and why there’s no need to be afraid of using it.

 

Smart placement of epinephrine will help you remember to take it with you.  It is important to note that you cannot store auto-injectors in your car (temperature fluctuations can affect whether the device will fire properly and how well the medication will work once injected).  Instead, consider leaving it on a hook by the door you exit out of, next to your phone or keys, or set a reminder on your phone to alert you 10 minutes before you’re due to leave the house.

 

There are always many ways to carry epinephrine.  A purse makes it easy.  But a drawstring cinch bag, gym bag or a backpack will work for men.  Some auto-injectors fit right into a pant pocket!  There are specialty products that help you carry your auto-injectors in inventive ways, such as running belts, wristlets, arm bands, leg holsters, clip-on bags, etc.

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Lastly, make it a habit.  You know that feeling when you forget your phone?  Or your lunch?  With regular practice, remembering your epinephrine will become second nature.

 

As Dr. Stukus sagely points out, emergencies are never planned.  They are not predicted.  Epinephrine auto-injectors are meant to be kept in arm’s reach.  Carrying your epinephrine is certainly a lot less hassle than going to the emergency room for the night.

 

Yes, You Can Get a Food Allergy at Any Age October 1, 2018

Food allergies aren’t always something you’re born with.  Many believe that once they reach preschool age without a food allergic reaction, both they and their children are out of the woods.  Not so, says allergists.

 

Unfortunately, food allergies can begin at any age.  In fact, you can get a food allergy to any food at any age.  We can all agree; that’s a bummer!

 

Unfamiliar with symptoms and without epinephrine, many adults discover their allergy through a reaction.   My own father-in-law had enjoyed seafood for decades before having a severe allergic reaction (called anaphylaxis) on an airplane when he was in his forties.  Thirty thousand feet over the Atlantic Ocean, he was served shrimp – something he had eaten many times before.  No sooner had he finished his meal than his symptoms begin: swollen eyes and esophagus, itchy mouth and skin.  Thankfully, he made it to their destination with the help of an overwhelming amount of Benadryl.  But I think we can all agree, that’s no place to discover a food allergy.

Shrimp salad chongdog pixabay

It can be confusing to adults (as well as to their families and friends), when someone can tolerate a food one day and react to it the next.  As with all families adjusting to food allergies, there is a huge learning curve that accompanies diagnosis.  Adult food allergy patients need to relearn how to shop, cook, order food and – importantly – they must learn to recognize symptoms of allergic reactions including anaphylaxis.

 

Just as with pediatric food allergies, symptoms range from mild to severe to include:

  • Itching or tingling mouth, lips and/or tongue
  • Hives, itching skin, eczema
  • Swelling of the tongue, throat, lips, eyes, face, or other parts of the body
  • Wheezing, nasal congestion or other trouble breathing
  • Abdominal pain, diarrhea, vomiting
  • Dizziness, lightheadedness, fainting

 

Symptoms of a severe reaction (called anaphylaxis) include:

  • Constriction of the throat or tightening of the airway
  • A swelling or lump in the throat that makes it feel hard to breath
  • Shock, a severe drop in blood pressure
  • Rapid pulse
  • Sense of impending doom
  • Dizziness, lightheadedness, loss of consciousness

*Emergency medical care is needed if experiencing any symptoms of anaphylaxis.  Even after administering an epinephrine auto-injector, seek immediate medical attention.

 

Busy adults sometimes miss symptoms of food allergies.  On occasion, adults experience vomiting without itching, swelling or hives – a symptom which imitates a virus or the flu.  After a suspected reaction, adults should meet with an allergist.  At their first appointment, patients should also discuss their other medical conditions as well as bring a list of prescription medication they take.  Specialists can help decipher between symptoms of one condition and food allergic reactions as well as give advice about any issues with administering epinephrine or taking antihistamines.

 

Too little is known about why adults develop food allergies.  Fifty-one percent of people with food allergies developed at least one as an adult.  Approximately 5% of adults live with food allergies in the United States.  The most common among them is shellfish (present in 54% of adults with food allergies), followed by tree nuts (43%).  But adults suffer reactions to all kinds of food allergens.  Although you can truly get a food allergy at any age, most adult reactions occur between ages 30 and 40 and affect women more often than men.

 

There is an initial emotional burden of being diagnosed with food allergies.  This is common. Food allergies can be especially stressful as patients are adjusting to their condition and retraining their behaviors or overcoming a severe reaction.  Experiencing anxiety is normal to some degree [please read Managing Food Allergy Anxiety]; however, if the stress and anxiety of food allergies becomes overwhelming, it is recommended that patients reach out to a mental health professional and mention it to their allergist.  Both can work to give you practical and easy-to-implement strategies to reduce fears.

 

 

FDA Approves First Generic EpiPen September 6, 2018

The U.S. Food and Drug Administration (FDA) has recently approved the first generic EpiPen to be made by Teva Pharmaceuticals.  There are currently several brands of epinephrine auto-injectors available to patients:  Mylan makes EpiPen, EpiPen Jr. and its own brand-sponsored generic; kaléo offers Auvi-Q; and Impax Laboratories markets Adrenaclick.  However, this generic EpiPen by Teva Pharmaceuticals will be the first time a non-brand alternative is available.

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Obtaining approval from the FDA for a generic was complicated by the fact that both the medication (epinephrine) as well as the device itself had to be reviewed.  There is no firm estimate on when to expect this new generic on the market or the cost of the product once it gets there.

 

The competition generated by a generic should help the epinephrine auto-injector market. To date, Mylan’s EpiPen has nearly monopolized the market but its exorbitant cost has gained unwanted attention.  Mylan’s EpiPen price has risen over 400% in the last 10 years to over $600 a set.  To counter the negative press, Mylan created their own generic EpiPen which still average $300 per set.  Patients and families are hoping the introduction of a true generic device will drive down the cost of the absolutely necessary, life-saving devices as well as help to prevent epinephrine auto-injector shortages like the one we’re experiencing presently.  They’re also hopeful this generic will help expand options covered by their insurance plans.  Doctors, emergency workers and advocates are also optimistic that this may help get epinephrine in the hands of patients who may otherwise be unable to afford it.

 

 

 

In-Flight Free-From Meals – Airlines Addressing Dietary Restrictions August 29, 2018

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If you’re taking to the air soon, you may be pleased to be able to request a special meal from your air carrier.  Airlines all over the world are responding to calls for special meals ranging from low-sodium and halal (made without pork or alcohol) to gluten-free.

 

Requests for special meals have increased over the years.  Historically, passengers have asked for specific meals for medical reasons or those that adhere to their belief system.  Experts wonder if the number of requests has increased because of the popularity of certain diets or the idea that special meals may be healthier or better tasting than those regularly served.  While that remains to be seen, the willingness to offer such meals is uplifting to patients with food allergies.

 

Both domestic and international travelers can take advantage of special orders covering a wide range of meal choices, but which ones your airline offers will vary from carrier to carrier, ticket type and destination.

 

Here’s a sampling of available allergy-friendly meals by airline.  As you will see, the meals Click on each airline to be directed to their site more details, including their policies on nuts and other allergens.

 

in-flight-meal-732953_1920 thank_you

 

Domestic Flights:

 

American Airlines

Glutose-Intolerant

Lactose-Intolerant

Vegan

 

Delta Airlines

Gluten-free

Vegetarian

 

United 

Vegetarian

Gluten-Intolerant

United policy for passengers with food allergies

 

 

International Carriers:

 

ANA

Allergen-Free Meals (choice between the 7 Allergen Free Meal and the 27 Allergen Free Meal)

7 Allergen Free Meal for Children

Gluten-Friendly

Low-Lactose

Seafood Meal (does not contain meat)

 

British Airways

various Vegetarian Meals

Gluten Intolerant

Low Lactose

 

JAL 

Gluten-Free

Vegetarian

Seafood Meal

Minimal Allergen Menu Meals

 

Luftansa

Gluten-Intolerant

Lactose-Intolerant

Vegan

Vegetarian

 

Malaysia Airlines

Gluten-Intolerant

Low Lactose

Vegan

various Vegetarian Meals

Seafood Meal

Special Meals

 

Qatar Airways

Gluten-Free

Non-Lactose

various Vegetarian Meals (also excludes fish, seafood, eggs and dairy)

 

Singapore Air

various Vegetarian Meals

Vegan

Gluten Intolerant

Low Lactose

Non-Strict Nut Free Meal

 

Turkish Airlines

various Vegetarian Meals (also excludes fish, seafood, eggs and dairy)

Gluten-Free

Low-Lactose

 

 

Please comment below if you’ve had one of these meals and let us know how it was!

 

EpiPen Shortage: What You Need to Know Now August 27, 2018

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You’ve likely heard that there’s a shortage on EpiPens through the United States, Canada, United Kingdom and Australia.  What began as spot shortages throughout Australia and North America has escalated into a worldwide panic.  Let’s separate fact from fiction to better understand this ongoing problem and talk about interim solutions.

 

1. There is NO epinephrine shortage.  The life-saving drug epinephrine, also known as adrenaline, is in full supply.

 

2. The shortage refers to pharmacy stock of Mylan’s EpiPen , EpiPen Jr. as well as its authorized generics in North America and the UK and only EpiPen 0.3 (300 mcg) in Australia.  According to Mylan, this shortage is due to manufacturing delays by their partner Pfizer/Meridian.

 

3.  There had been a shortage of Impax Laboratories’ Adrenaclick, but that appears to have been resolved.

 

4.  Some pharmacies in the United States (including Kaiser) are reportedly rationing out only ONE pen to customers.  This is not recommended.  Customers should always carry two auto-injectors in case one pen malfunctions or two doses of epinephrine is required while waiting for emergency services.

 

5.  There IS NO SHORTAGE of Auvi-Q – the innovative epinephrine auto-injector that talks you through how to administer a shot and has a retractable needle to prevent accidental injury.

 

While this problem affects everyone trying to refill a prescription at this time, I am particularly concerned with those trying to fill a prescription for the first time.  Those patients and families who are just getting a diagnosis and hoping to find a little security in the sometimes overwhelming world of food allergies may find themselves unprepared or totally confused by the process.  I’m also worried for schools and daycares, whose stock epinephrine program saves lives.

 

What can you do while you’re waiting for the EpiPen supplies to increase?

 

1. The U.S. Food and Drug Administration has extended the expiration date of Mylan’s EpiPens by 4 months.  There is a list of which batches are affected and their extended expiration dates listed on FDA’s site – be sure to check your boxes.

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2. Should you need a set of epinephrine auto-injectors now, there ARE alternatives to EpiPens:

auvi-q-production-line

  • In the United States, Auvi-Q is in full supply.  Please visit Auvi-Q’s website for instructions on how to arrange direct delivery.
  • Adrenaclick is also in stock in the United States.  Talk to your doctor and pharmacist about getting this filled in EpiPen’s place.  Be reminded, you’ll need to order a free trainer from Impax Laboratories to practice on this device.  It’s smaller than an EpiPen but operates just a little differently.  You may call Impax Laboratories at 1-855-EPINEPH to order them directly.
  • In the UK, both Jext and Emerade are available epinephrine auto-injectors.

 

3.  Should you prefer to wait for EpiPen to become available: 

  • Check the expiration date on your auto-injectors.  As long as they are stored at room temperature (and not, for example, in the car in the heat), you should be fine to use them past their expiration date according to the FDA.  According to Dr. Baker (formerly director of FARE), EpiPens can be used up to 6 months past their expiration date.
  • Check the epinephrine in your EpiPen.  If you look through the window of your EpiPen and see that the epinephrine is discolored or cloudy, it is no longer good.
  • Be sure to speak with your child’s school about the expiration date extension so that you will be allowed to store that set of EpiPens there.
    • Make a plan (and put it on the calendar!) to replace the EpiPens and deliver a fresh set to school when they become available;
    • Discuss if and how procedures will change with an expired EpiPen.  Will the school use that auto-injector or will they choose to use stock epinephrine instead?  Does that effect the timing of a call to emergency services? What is YOUR preference?
  • As always, store your epinephrine properly.  That means keeping them at room temperature as much as possible.
  • Be careful about accepting a refill from a pharmacy that wants to give you only one auto-injector, splitting up a set.  Heads up: We have heard reports of pharmacies charging a regular co-pay for even just ONE pen.  And, again, patients at risk for anaphylaxis must ALWAYS CARRY TWO auto-injectors at all times.
  • The beginning of a school year is the perfect time to review food allergy safety with your children (wash hands with soap and water before eating, no sharing food, symptoms of a reaction, what to do and who to tell).  Here are some great books to use as a jumping off point for your conversations.

 

If you’re new to the food allergy world and getting an epinephrine auto-injector for the first time, consider one of the available auto-injectors on the market if possible.  They are all equally effective and potent.  You may even find that they fit your needs and lifestyle Discuss with your doctor which one may be most appropriate for you based on your age, capabilities and lifestyle.

 

For more information, please read WebMD’s article “EpiPen Shortage Causing Concern as School Starts”.

 

kaléo Introduces First Ever Epinephrine Auto-Injector for Infants and Toddlers April 30, 2018

Filed under: Preparedness — malawer @ 8:30 am

A food allergy diagnosis is jarring at any age.  But it is particularly unsettling when your baby or toddler is diagnosed.  Parents worry that they may not be able to recognize the symptoms of a severe allergic reaction called anaphylaxis.  Large-sized auto-injectors seems especially intimidating and parents often worry that the dose of epinephrine will overwhelm their infants’ small, little bodies.

 

Until recently, the 0.15mg dosed auto-injectors – typically used for children weighing between 33 and 66 lbs (15 – 30 kilograms) – were the only option for infants and toddlers.  However, kaléo Pharma, the makers of Auvi-Q, just announced that the FDA has approved Auvi-q 0.1mg  – a strength intended for infants and toddlers.

 

At a time when the rate of food allergies is still increasing and pediatricians are recommending the early introduction of peanuts and other allergens to prevent the development of food allergies, this device is arriving in the nick of time for food allergy parents.  It is everyone’s hope that Auvi-q’s correctly-dosed auto-injector will embolden parents to confidently administer epinephrine to their young children without hesitation.

 

Image result for Auvi-q 0.1

The FDA-approved Auvi-q 0.1mg will have several features that are better suited for little ones.

  • It is dosed properly for infants and toddler weighing between 16.5 and 33 lbs (7.5 to 15 kilograms)
  • It contains a needle length appropriate for smaller bodies, reducing incidents of injury.

 

If you’re not familiar with the Auvi-Q epinpehrine auto-injector, it’s a compact auto-injector about the size of a deck of cards.  Auvi-Q features voice prompts to guide you through injection step-by-step and contains a needle that automatically retracts for safety.

 

 

If you have a baby or toddler and would like more information, here is a link to Auvi-q’s 0.1 page and, as always, speak with your doctor.