Tag: food allergies

Options During the Epinephrine Shortage

Although there are still shortages of epinephrine, you have more options than you might think.

Of the medicines that you would hope that we would never run out of, epinephrine is probably on the top of the list for many people.

Unfortunately, many parents are still stuck dealing with shortages and delays of epinephrine injectors.

Why?

“The purpose of this letter is to inform you that in a very small number of cases, some EpiPen® 0.3 mg and EpiPen Jr® 0.15 mg Auto-Injectors, and their authorized generic versions, may not easily slide out of their carrier tube, which could delay or potentially prevent use of the device during an emergency.”

Dear Healthcare Provider Letter for Potential Label Defect of EpiPen Auto-Injectors and its Authorized Generic

For EpiPens, there was a problem with the labels on the injectors so that “in a very small number of cases, labels were not fully adhered to the surface of the auto-injector such that the device label may become stuck to the inside of the carrier tube.”

And for the Adrenaclick generic injectors, “Some lots of Epinephrine Injection auto-injector have passed all levels of inspection and met product specifications at the manufacturing facility, but have been found to contain particles upon further inspection.”

So both are now suffering from manufacturing delays after fixing these issues.

Luckily, most still have options for their kids with severe allergies.

Options During the Epinephrine Shortage

Can’t get your child’s prescription for epinephrine filled?

“Currently, EpiPen, EpiPen Jr and Adrenaclick remain in either a spot shortage or constrained supply.”

Alert – Epinephrine Shortage Update September 17, 2019

One of the first things to keep in mind is that the FDA has allowed for temporary extensions of expiration dates:

So check the NDC number and the original expiration date and see if you even need a refill yet.

The FDA has allowed for temporary extensions of expiration dates for some epinephrine injectors.

Next, know that many more versions of epinephrine are available than ever before!

If you can’t refill your child’s prescription because your pharmacy doesn’t have it, you might ask them which form of epinephrine they do have in stock, and then ask your pediatrician if you can use that version.

There are now six forms of epinephrine injectors available (with three that may be hard to find), including:

  • EpiPen, EpiPen Jr – coupon – the auto-injector with the notorious reputation for the $670 retail price tag
  • Epinephrine injection (EpiPen, EpiPen Jr authorized generics) – coupon
  • Epineprhine injection (EpiPen, EpiPen Jr Teva manufactured generics) – coupon
  • Adrenaclick Adult, Child authorized generic – coupon – this is the epinephrine auto-injector that is available for $109.99 at CVS
  • SYMJEPI 0.3mg, 0.15mg – coupon – a new epinephrine pre-filled, ready-to-use device – not an auto-injector!
  • Auvi-Q – financial support – the epinephrine auto-injector that talks to you and has the notorious reputation for the $5,000 retail price tag

Whichever version you get, if you have commercial insurance without a high deductible, the coupon will likely cover your copay.

There are now six versions of epinephrine injectors available for children and adults with severe allergic reactions.
Can your pharmacy get you the Teva manufactured generic EpiPen or EpiPen, Jr?

And in a worst case scenario, if necessary, use an expired epinephrine injector, even if it is out of range of an extension, and seek immediate medical attention.

“If an in-date auto-injector is not available, it is better to use an expired auto-injector than to not give epinephrine.“

Expired Epinephrine Can Still Save Lives

Still confused?

Hopefully you won’t be when you need to use your child’s epinephrine injector!

One very big issue with so many different types of epinephrine injectors is that their instructions for use are a little different.

“There are several different epinephrine auto-injectors available – Mylan EpiPen and Mylan Generic, Auvi-Q, and Adrenaclick; these auto-injectors have different steps for use.”

How to Use an Epinephrine Auto-Injector

We can also hope that once the shortages are resolved, a little competition will bring down the prices of all of these drugs, as even the generic EpiPens are at least $300!

More on Options During the Epinephrine Shortage

Have Questions About the First Generic Version of EpiPen?

Now that we have a real generic version of the EpiPen, what can we expect to happen to the prices of epinephrine injectors?

Have you heard the news that the FDA has approved the first generic version of the EpiPen?

“The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds.”

FDA Press Announcement on FDA approves first generic version of EpiPen

That’s likely surprising news to all of those folks who have been prescribing and using generic epinephrine injectors this past year.

Is This Really the First Generic Version of EpiPen?

Many remember that we all talk about EpiPens so much because their cost jumped from about $100 in 2006 to over $600 in recent years.

The current generic epinephrine injectors are authorized generics, so didn't need FDA approval.
The current generic epinephrine injectors are authorized generics, so didn’t need extra FDA approval.

That prompted Mylan, the company that makes the EpiPen 2-Pak and EpiPen Jr 2-Pak, to come out with a half-price authorized generic version last year.

“An authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer.”

An authorized generic Adrenaclick injector also became available for a cash price of $109.99 CVS pharmacies. Combined with a $50 coupon, that’s often your best deal on an epinephrine injector if you don’t have insurance.

How Much Will the First Generic Version of EpiPen Cost?

And now we have a true generic version of the EpiPen 2-Pak and EpiPen Jr 2-Pak, from Teva Pharmaceuticals USA.

“The reduction in upfront research costs means that, although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at substantially lower costs.”

FDA on Generic Drug Facts

Will it be cheaper than current EpiPens?

“When multiple generic companies market a single approved product, market competition typically results in prices about 85% less than the brand-name.”

FDA on Generic Drug Facts

It should be, but how much cheaper will it be?

“A company spokeswoman declined to say when it would be available, or how much it would cost.”

F.D.A. Approves Generic EpiPen That May Be Cheaper

While most folks would be happy with a $90 EpiPen and a tier 1 generic copay, I wouldn’t count on it. For one thing, we technically don’t have multiple generic EpiPens competing against the TEVA EpiPen yet.

And looking at drug prices of some of TEVA’s other medications, you can get a clue about their pricing plan:

  • Airduo generic (similar to Advair, but about 1/4 the price) – $98
  • Qvar (similar to Flovent) – $200
  • ProAir (albuterol inhaler) – $71
  • Budesonide Inhalation Suspension (generic Pulmicort Respules) – $176
  • Levalbuterol Inhalation Solution, USP (generic Xopenex) – $121
  • Clindamycin Phosphate and Tretinoin Gel (generic Ziana) – $600
  • Cefdinir oral suspension (generic Omnicef) – $45
  • Syprine (generic trientine hydrochloride) – $18,375

Their drugs typically ain’t cheap…

Will the first generic version of the EpiPen simply be a little cheaper than the authorized generic or can we expect TEVA to offer it at substantially lower cost?

What’s your guess?

More on the First Generic Version of EpiPen

Is There a Cure for Peanut Allergies?

Oral immunotherapy and some other treatments are providing new options to help kids with severe food allergies avoid life-threatening reactions.

Many parents likely got excited recently when they read about a possible cure for peanut allergies.

Peanut allergy could be cured with probiotics
Medical News Today

While these types of treatments are called cures by some people, what they do is desensitize you to peanuts, so that if you have a reaction, it is less severe. Some don’t have reactions anymore though. Probiotics were just part of the ‘cure’ though. They were paired with oral immunotherapy.

Is There a Cure for Peanut Allergies?

So is there really is a cure for peanut allergies?

I’m guessing it doesn’t matter if you call it a cure or a treatment if you have a child with a severe peanut allergy, you really just want to know if it is available for your child, right?

And again, there isn’t a simple answer.

Although it does seem like they are being used more and more, many of these treatments are still being tested, so they likely aren’t available everywhere, or in some cases, anywhere outside of a trial.

Among the treatments for peanut allergies, besides avoidance and treating anaphylactic reactions with epinephrine, you some day soon might be able to get your child with peanut allergies:

  • a wearable skin patch to provide epicutaneous immunotherapy (EPIT)  – in phase III studies
  • a pill to provide orally administered biologic immunotherapy  – in phase III studies
  • oral immunotherapy with Xolair (FASTX) – in phase II studies
  • a combination of probiotics with peanut oral immunotherapy (PPOIT)
  • sublingual immunotherapy (SLIT) – in phase III studies
  • a vaccine – in early phase I studies

How do these treatments work?

The patch is the easiest to explain. Kids simply apply a new patch that contains peanut protein on their skin each day.

Oral immunotherapy is similar, kids are exposed to peanut protein, but unlike the patch, the dose is steadily increased each day, until you read a maintenance dose, that you continue eating each day. Most of these treatments use some variation of the characterized oral desensitization immunotherapy (CODIT) method to control and maintain desensitization.

And these treatments are not just for peanuts. Similar studies are being done for eggs and milk. And theoretically, they can be done for anything that can trigger an IgE-mediated allergic reaction, from foods and medicines to environmental allergens.

The downside? In addition to side effects, in most cases, you have to continue eating the thing you are allergic to every day, otherwise your allergy might return.

So, Is There a Cure for Peanut Allergies?

While many of these treatments are promising, they are not ready for regular use in every doctor’s office.

“The aim of OIT is to administer a food allergen slowly, in small but steadily increasing doses, until the patient stops reacting to the food (termed becoming desensitized to the food). OIT studies have shown promising results, though adverse reactions are frequent and may cause significant side effects like abdominal pain, wheezing and/or diarrhea. Published data from placebo-controlled trials have shown that only 50 to 70 percent of patients attempting OIT complete desensitization, with the failures primarily due to side effects. Also, there currently are no standardized protocols or foods used in OIT and no FDA approved approach that could allow insurance to reimburse for this therapy. Thus, there are challenges with the current practice of OIT.”

FARE Statement on Oral Immunotherapy for Food Allergies

That doesn’t mean that you can’t get some of these treatments right now or overcome those challenges.

Avoiding peanuts is not always as easy as you think... Peanuts under my seat on a plane.
Avoiding peanuts is not always as easy as you think… Peanuts under my seat on a plane. Photo by Vincent Iannelli, MD

Just keep in mind that “An allergist doing OIT for patients in a private practice develops his/her own individualized protocols and uses his/her unique food preparation.”

If your child’s food allergy has led to severe stress and anxiety for your family, that might not matter though. You probably don’t want to wait anymore if there is a chance at reducing your child’s chance of having a severe, life-threatening allergic reaction.

Still, find a pediatric allergist who has a lot of experience doing private practice OIT.

On the other hand, if you are fine refilling your child’s epi-pens every year and working hard to avoid peanuts, then maybe wait until the jury comes in and we get an official recommendation and more standardized treatments become more widely available.

What Else Should You Be Doing About Food Allergies?

If you don’t do private practice OIT, then in addition to strictly avoiding the things to which your child is allergic and making sure that an epi-pen is always readily available, the latest guidelines recommend that your child have:

  • annual testing if they have a milk, egg, soy, or wheat allergy
  • testing every two to three years if they have a peanut, tree nut, fish, or shellfish allergy

Why retest?

Kids do sometimes outgrow their allergies, especially if the allergy isn’t to peanuts or tree nuts. And even for peanuts, about 20% of kids have a chance of outgrowing their allergy.

Also remember that it is now recommended that infants at high risk for peanut allergies, especially those with eczema, have an early introduction of peanut proteins, sometimes as early as four months of age.

Hopefully that will help decrease the number of kids who need these kinds of treatments in the future.

What to Know About Treating Peanut Allergies

Oral immunotherapy and some other treatments are providing new options to help kids with severe food allergies avoid life-threatening reactions.

More About Treating Peanut Allergies

What is Causing your Child’s Diarrhea?

While diarrhea is common in kids and we often don’t figure out the specific cause before it goes away on its own, there are clues that can help you figure out if your child’s diarrhea is caused by a virus, bacteria, parasite, or other condition.

Often described as the "cruise ship virus," you can get norovirus infections in daycare centers, schools, or after eating at a restaurant.
Often described as the “cruise ship virus,” you can get norovirus infections in daycare centers, schools, or after eating at a restaurant. (CC BY-SA 2.0)

Why does your child have diarrhea?

Could it be the “stomach flu,” food poisoning, or just an intolerance to something your child eat?

Common Causes of Diarrhea

While parents often quickly jump to the idea of “food poisoning,”  infections are typically the most common cause of diarrhea in kids.

These include:

  • viruses – rotavirus (a vaccine preventable disease), adenovirus, and norovirus
  • bacteria – C. diff, Salmonella, Shigella, E. coli, Campylobacter jejuni, Bacillus cereus, Listeria, Cholera
  • parasites – Cryptosporidium, Giardia, Cyclospora

Not all diarrhea is caused by infections though. If the diarrhea lingers for more than a few weeks or keeps coming and going, then you might consider that your child might have a lactose intolerance, irritable bowel syndrome, Celiac disease,  or other non-infectious cause.

Hints of Diarrhea Causes and Risk Factors

To help figure out what might be causing your child’s diarrhea, consider these questions and share the answers with your pediatrician:

  • Does your child have bloody diarrhea (sometimes a sign of a bacterial infection)?
  • Is your child getting dehydrated? While that doesn’t tell you want is causing the diarrhea, it is a good sign that you need to seek medical attention.
  • Does your younger child (under age 2 to 4 years) have bloody diarrhea that is becoming jelly-like and episodes of severe, colicky abdominal pain (sign of intussusception)?
  • Is your child in daycare? Has anyone else recently been sick with diarrhea or vomiting?
  • Has your child recently been on antibiotics (a risk for C. diff)?
  • Does your toddler with diarrhea drink a lot of juice (Toddler’s diarrhea)?
  • Have you recently traveled out of the country (Traveler’s diarrhea)? Did your child get sick a few days later (could be a bacterial or viral cause) or a few weeks later (parasites have longer incubation periods)?
  • Has your child recently spent time on a lake or river and possibly drank untreated water (risk for Giardia infection)?
  • Do you have any high risk pets, including turtles, snakes, lizards (or other reptiles); frogs, salamanders, newts (or other amphibians); chicks, chickens, ducklings, ducks, geese, and turkeys (or other poultry); mice, rats, hamsters, and guinea pigs (or other rodents); or farm animals (all can be a risk for Salmonella)?
  • Have you recently visited a farm or petting zoo (risk for Salmonella and E. coli)?
  • Has your child recently visited a water park or public swimming pool (risk for Cryptosporidium)?
  • Does your child drink raw milk, unpasteurized juice, raw or undercooked eggs, or undercooked beef, pork, and poultry (risk for food poisoning)?
  • Has your child recently eaten leftover food that had been unrefrigerated for more than two hours (risk for food poisoning)?
  • Is the diarrhea worse after your child drinks a lot of milk or eats a lot of dairy (a sign of lactose intolerance)?
  • Does your child have alternating episodes of constipation and diarrhea (irritable bowel syndrome)?
  • In addition to chronic diarrhea, is your child irritable, with poor weight gain and other symptoms (a sign of Celiac disease)?
  • Does your child also have abdominal pain or just diarrhea?
  • Is your child taking any medications that might cause diarrhea as a side effect?

Once you have narrowed down the possibilities, blood and stool tests, including stool culture tests for bacteria, parasites, and viruses can sometimes help to figure out what is causing your child’s diarrhea. Keep in mind that these are usually reserved for diarrhea symptoms that are severe (bloody diarrhea, fever, weight loss, etc.)  or lingering for more than a few weeks.

And remember that the most common causes of diarrhea, including food poisoning and viral infections, typically go away on their own without treatment. In fact, you can make things worse if you treat some causes of diarrhea with antibiotics, including some Salmonella, Shigella, E. coli infections.

Still don’t know what is causing your child’s diarrhea? In addition to your pediatrician, a pediatric gastroenterologist can be helpful when your child has diarrhea.

What To Know About Diarrhea

While diarrhea is common in kids and we often don’t figure out the specific cause before it goes away on its own, there are clues that can help you figure out if your child’s diarrhea is caused by a virus, bacteria, parasite, or other condition.

For More Information on Diarrhea

Avoiding Confusion During an Allergy Attack – Adrenaclick vs EpiPen Directions

Learn how to avoid confusion by learning when and how to use different epinephrine injections, including the EpiPen and Adrenaclick injectors.

Whether you have an EpiPen or Adrenacick injector, make sure everyone around your child with allergies knows how to use it.
The FARE Food Allergy & Anaphylaxis Emergency Care Plan provides detailed instructions for all available epinephrine injectors.

The price of EpiPens has been in the news a lot recently.

Most people know that they went Mylan’s EpiPen 2-Pak went from costing about $100 in 2006 to over $600 today and that there has been little or no competition.

One competing device, Auvi-Q was recalled in 2015, but it was fairly expensive too.

Good News and Bad News About EpiPens

Things have gotten better recently.

First, a generic EpiPen 2-Pak is now available. It costs $339.99. While still expensive, it does lower co-pays for many people with good insurance.

The latest news? A generic Adrenaclick injector for $109.99 at CVS pharmacies.

Even better, coupons are available that can make the injectors free for many people.

So what’s the bad news?

The directions for using the EpiPen 2-Pak and the Adrenaclick are not the same. That can cause some confusion. Do you want someone to grab one and not be sure how to use it when your child is having a life-threatening allergic reaction?

That makes it important for everyone to be familiar with both types of epinephrine injectors.

Adrenaclick vs EpiPen 2-Pak Directions

The fact that the Adrenaclick has two caps that you need to remove before use, while the EpiPen only has one, can lead to confusion. Also, the Adrenaclick injector, despite its name, doesn’t actually ‘click’ after you use it, like the EpiPen does.

EpiPen 2-Pak auto-injector directions:

  1. Remove the EpiPen Auto-Injector from the clear carrier tube to find an EpiPen Jr (green label) or EpiPen (yellow label).
  2. Remove the blue safety release by pulling straight up without bending or twisting it.
  3. Swing and firmly push orange tip against mid-outer thigh until it ‘clicks’.
  4. Hold firmly in place for 3 seconds (count slowly 1, 2, 3).
  5. Remove auto-injector from the thigh and massage the injection area for 10 seconds.

Remember that the orange end is the needle end! And you know that your child got your dose if you heard the click sound.

Adrenaclick epinephrine auto-injector directions:

  1. Remove the outer case.
  2. Remove grey caps labeled “1” and “2”.
  3. Place red rounded tip against mid-outer thigh.
  4. Press down hard until needle enters thigh.
  5. Hold in place for 10 seconds. Remove from thigh.

With the Adrenaclick injector, the red tip end is the needle end! Do not touch this end or you could unintentionally inject your self. After use, the needle should be visible.

Avoiding Confusion About Your Epinephrine Injector

All of the epinephrine injectors are easy to use. At least on paper.

In the heat of the moment though, when a child is having a life-threatening allergic reaction, it may not seem so easy though.

It will likely be even more difficult if the epinephrine injector you grab is not what you are expecting. Make sure you know how to use your epinephrine injector, both when your pediatrician prescribes it and when your pharmacist dispenses it to you (in case you get a different one, which is allowed in some states).

  1. Read the instructions.
  2. Watch a video.
  3. Use a trainer device.
  4. Be prepared!

It is also important that anyone that watches your child, whether it is a family member or the school nurse, knows how to use your child’s epinephrine injector.

“Individuals and caregivers are often reluctant to use self-injectable epinephrine in anaphylaxis despite instruction to do so.”

Pediatrics March 2007

Other things that can lead to confusion about epinephrine injectors include that you:

  • use an EpiPen or Adrenaclick training pen instead of the real injector with active medication when your child is having an anaphalytic reaction
  • use the real injector when you meant to use the training pen
  • don’t carry your child’s epinephrine injector with you at all times, which is why it is important to get more than one injector each time, allowing you to keep one at school, one at home, and one and travels with your child, etc., eventually allowing your child to carry his or own epinephrine injector at an age-appropriate time
  • forget to move to a higher dose of epinephrine as you child grows, keeping in mind that the Jr (0.15mg) dosing is only for kids under 66 pounds
  • aren’t sure when to use your EpiPen or Adrenaclick injector or are afraid to use it, which can lead to an unnecessary delay in your child getting a lifesaving treatment
  • don’t get a refill if your epinephrine injectors have expired or you actually needed to use one
  • understand that you still need to call 911 after you have used your epinephrine injector, even if your child begins to immediately feel better. Symptoms can return, which is why you are given two doses (2-Pack) of epinephrine.

A good Food Allergy & Anaphylaxis Emergency Care Plan can help avoid much of this confusion. In addition to easy to read instructions on when to give epinephrine, this type of plan should include directions for your child’s epinephrine injector.

When in doubt – you should usually give epinephrine if you have any concerns that your child is having an anaphylactic reaction. It is a safe medicine.

More Information About Epinephrine Injectors

Save

Save

How To Avoid Peanut Allergies

To prevent peanut allergies, parents of high risk kids are being told to go out of their way to be sure that they actually feed their infants peanut-containing foods!

Infants with eczema are at high risk for developing peanut allergies.
Infants with eczema are at high risk for developing peanut allergies. Photo courtesy of the NIAID.

The worst part of having a severe allergy to peanuts isn’t the high price of EpiPens.

It is that peanut allergies can be deadly, even when you have access to an EpiPen.

And since there is no 100% fool proof way to avoid peanuts and peanut containing foods, doctors have been trying to come up with ways to prevent kids from ever developing peanut allergies.

The first efforts, to avoid peanuts and other high risk foods during pregnancy and early infancy, likely backfired, leading to even more kids with peanut allergies. That’s why recommendations for starting solid foods changed back in 2008, when the American Academy of Pediatrics began to tell parents to no longer delay giving solid foods after age 4 to 6 months and that it wasn’t necessary to delay “the introduction of foods that are considered to be highly allergic, such as fish, eggs, and foods containing peanut protein.”

The latest guidelines are the next evolution of that older advice.

Now, in addition to simply not delaying introducing allergy type foods, as part of a new strategy to prevent peanut allergies, parents of high risk kids are being told to go out of their way to be sure that they actually give their infants peanut-containing foods!

Prevention of Peanut Allergies

Developed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, with 25 professional organizations, federal agencies, and patient advocacy groups, these clinical practice guidelines recommend that parents:

  1. introduce peanut-containing foods into your infant’s diet as early as 4 to 6 months of age if they have severe eczema, egg allergy, or both (strongly consider allergy testing first)
  2. introduce peanut-containing foods into your infant’s diet around 6 months of age if they have mild to moderate eczema
  3. introduce peanut-containing foods into your infant’s diet in an age-appropriate manner with other solid foods if your infant has no eczema or any food allergy

Keep in mind that it is possible that your baby already has a peanut allergy, so discuss your plan to introduce peanut-containing foods with your pediatrician first. But don’t be in such a rush that you make peanut-containing foods your baby’s first food. Offer a cereal, veggie, fruit, or meat first. If tolerated, and you know that your baby is ready for solid food, and with your pediatricians okay, then consider moving to peanut-containing foods.

And although not always necessary, it is possible to do allergy testing even on younger infants. Testing is an especially good idea if your infant has severe eczema or an egg allergy. For these higher risk kids, referral to an allergy specialist might even be a good idea, where infants can start peanut containing foods in their office (supervised feeding) or as part of a graded oral challenge. Your pediatrician might also consider supervised feeding for your higher risk child who is not allergic to peanuts.

Peanut-Containing Baby Food Recipes

So how do you give a 4 or 6 month old peanut-containing foods?

It’s not like Gerber has any 1st or 2nd foods with peanuts – at least not yet…

So for now, you can:

  • add 2 to 3 tablespoons of hot water to 2 teaspoons of thinned, smooth peanut butter. Stir until the peanut butter dissolves and is well blended. You can feed it to your baby after it has cooled.
  • mix 2 to 3 tablespoons of a fruit or veggie that your baby is already tolerating in 2 teaspoons of thinned, smooth peanut butter.
  • mix 2 to 3 tablespoons of a fruit or veggie that your baby is already tolerating in 2 teaspoons of peanut flour or peanut butter powder.

Each of these recipes will provide your baby with about 2g of peanut protein. Since the goal is to give your child about 6 to 7g a week, you should offer them three separate times.

During the first feeding, it is important to only “offer your infant a small part of the peanut serving on the tip of the spoon,” and then wait for at least 10 minutes to make sure there are no signs of an allergic reaction, such as hives, face swelling, trouble breathing, or vomiting, etc.

Of course, because of the risk of choking, you should not give infants or toddlers whole peanuts or chunks of peanut butter.

More Information on Preventing Peanut Allergies

%d bloggers like this: