Allergy Shmallergy

Simplifying life for families with food allergies.

Important Story: FDA Warning to Mylan, Maker of the EpiPen, on Device Defects and Review November 6, 2017

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Earlier this fall, the FDA issued a warning to Mylan, the makers of EpiPens.  In a scathing letter, the FDA highlighted manufacturing defects as well as Mylan’s failure to conduct adequate internal reviews after receiving many complaints about the life-saving device, EpiPen’s malfunctions.  To date, there have been 7 deaths, 35 hospitalizations and 228 complaints about EpiPen and EpiPen Jr. devices this year.  [See F.D.A Accuses EpiPen Maker of Failing to Investigate Malfunctions, New York Times, Sept. 7, 2017]

 

Following an FDA inspection of the manufacturing plant, FDA’s letter to Mylan describes EpiPens that were leaking epinephrine and others that malfunctioned.  In March of this year, Mylan issued a recall of a small batch of EpiPen and EpiPen Jr devices.

 

While it is difficult to connect these defects to the deaths reported, as anaphylaxis itself can be deadly even with properly receiving epinephrine, these reports are not encouraging.

 

In February of this year, we had a frightening experience. [Please read the full story,  The Fire Drill- 5 Key Lessons from an Intensely Scary Night.]  Not long after eating at a restaurant, my 12 year old, food allergic son was rushed home, wheezing severely and coughing.  He was so weak and nauseous that he could barely stumble to the bathroom.  As I asked him questions, trying to evaluate the situation, it was becoming increasingly impossible for him to speak at all.  I wheeled around to grab my EpiPens just steps from where my son sat.  When I turned back around, he was blue.

 

This is every parent’s worst nightmare.  It was certainly mine.  Amidst the chaos of an increasingly critical and deteriorating situation, my only saving grace was that I held in my hand an EpiPen that would contain the correct amount of the life-saving drug, epinephrine and deliver it safely.

 

I can’t imagine being in that same moment now, knowing that the EpiPen in my hand may or may not save my son’s life.  That it may or may not have the right dose of medicine.  That the needle may or may not misfire.  Would the knowledge of EpiPen defects cause you to hesitate?  Would you instead call an ambulance that would take even more time to arrive?  When minutes matter, these short hesitations in action, improper delivery of medication, and any other complications that arise during anaphylaxis could be costly…. even deadly.

 

Bear in mind, Mylan has also increased the cost of EpiPen from $50 in 2008 to over $600 currently.  And, while the high cost of EpiPens are prohibitive, parents are still buying them, and they’re paying for one thing:  reassurance.  They pay for the firm knowledge that this product administers the correct amount of medicine properly every time.  If that can’t be demonstrated, there are plenty of other auto-injectors on the market with a proven track record of reliability to consider.

 

Despite these less-than-comforting reports, please continue to carry and use your EpiPens and other auto-injectors.  According to the FDA in a recent Bloomberg article, “We are not aware of defective EpiPens currently on the market and recommend that consumers use their prescribed epinephrine auto injector. We have seen circumstances in which adverse events reports increase once a safety issue is publicized, like a recall. We continue to monitor and investigate the adverse event reports we receive.”

 

I plan to keep you all informed as we continue to follow this story.

 

To read more on this story, please see EpiPen Failures Cited in Seven Deaths This Year, FDA Files Show posted on Bloomberg, Nov. 2, 2017.

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Prep Your Meds for School: Refill Options July 28, 2017

Time to get your emergency medications ready for school.  Don’t worry:  there’s still lots of summer fun to be had!  But to maximize summer fun over back-to-school frenzy, there are a few things you can do.

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  1. Check the Date:  Check the expiration dates on your epinephrine auto-injectors.  If they are due to expire between now and December, it may be a good time to consider refilling your prescription.
  2. Know Your Options:
    • There are several choices of epinephrine auto-injectors these days and they all efficiently deliver the same life-saving drug (epinephrine) in different ways.  I’ll outline those different auto-injectors below.
    • Talk to your doctor and consider your lifestyle when choosing your auto-injector.
    • Be sure you, your school nurse, caretaker, and child are all familiar with how to operate the auto-injector(s) you choose to stock at home, school and elsewhere.
  3. Update Your Emergency Action Plan:  Your doctor may have provided you with one or you can take Allergy Shmallergy’s Emergency Action Plan to your doctor on your next appointment.  Make a copy for home, your car, on-the-go, and school.
  4. Ask Directly:  You may need to ask your doctor specifically for the auto-injector you wish to use.  Some doctors prescribe only one without discussion, but are certainly willing to write a prescription for the auto-injector that works best for you.

 

What ARE the options for epinephrine auto-injector:

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Auvi-Q:

Yes, it’s back on the market and better than ever.  Auvi-Q delivers epinephrine via a compact package that speaks to you.  You heard that right: it talks you through an injection, even counting down the length of time you are supposed to hold the device in place.  Plus, the needle automatically retracts, reducing the possibility of post-injection injury.  Each Auvi-Q is about the size of a deck of playing cards, easy to carry for everyone (especially teens, young adults and fathers – who can fit them in their pockets).

 

*Auvi-Q automatically ships and delivers their auto-injectors directly to you.  Initiate this process with your doctor.  To read more about their direct delivery service as well as their cost-coverage programs, refer to the Affordability program page.

 

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Adrenaclick:

Adrenaclick has a slimmer profile than the well-know EpiPen, but is about the same length. Adrenaclick is a no frills epinephrine auto-injector, often used as a generic for EpiPen.  In fact, responding to the rising costs of brand name epinephrine auto-injectors, CVS pharmacies (among others) replaced its stock of auto-injectors with Adrenaclick. In their words, “Patients can now purchase the authorized generic for Adrenaclick®… This authorized generic is a Food and Drug Administration (FDA)-approved device with the same active ingredient as other epinephrine auto-injector devices.”

 

*IMPORTANT, Adrenaclick operates differently than EpiPens and they DO NOT come with a trainer.  If you choose to use this useful auto-injector, be sure to also place an order for an Andrenaclick trainer.  And, do your research for best pricing locally.

 

EpiPen:

EpiPens are the most widely used and most familiar of the epinephrine auto-injectors.  In fact, its familiarity is what keeps many customers coming back.  School nurses and even non-allergic individuals may be more accustomed to its look and how to use it.  In addition, EpiPens are substantial – making them easy to find in a backpack or purse.  In 2016 Mylan, the manufacturers of EpiPen, released a generic of its own product in response to public pressure over its pricing.  Both products contain the same medication and use the same or similar injector mechanisms.  EpiPen’s price has not been reduced in any way and is the most expensive auto-injector on the market.  The generic version is less expensive, but still a price worth considering for many.

*Mylan does offer coupons which can be found on their website.

 

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.

 

Your Growing Child: How to Carry Epinephrine August 11, 2015

Filed under: Preparedness,Uncategorized — malawer @ 10:00 am
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As a parent of a food allergic child, you are the person responsible for carrying your son/daughter’s epinephrine and other rescue medication.  As your child ages, however, he will not only go on play dates or attend sports practices and games without you, but she’ll want to go the movies with her friends or walk around the school fair.

My son, who is now 10, has shown a definite preference to carry his own epinephrine in certain situations.  If he’ll be indoors (or it’s cool out), he’ll stick it in his sporty cinch backpack alongside an inhaler and whatever else he brings along that day.  If it’s hot out, we throw the meds in an insulated lunchbox alongside an ice pack or a bottle of ice water and place that inside a cinch bag.

As he grows he may wish to try a few alternatives to remain prepared.  If you’re an adult or teenager with allergies, there are a few convenient ways to wear (yes, wear) epinephrine below.  In fact, I plan to get a few for MYSELF to help him carry his rescue meds while we’re active or on-the-go.

Keeping your or your kids’ rescue meds with them should be easy – no matter which autoinjector you prefer.  Below are some pretty cool and easy ways to carry epinephrine no matter where you go or what you do.  *Just remember, epinephrine needs to be kept at room temperature or below to keep from compromising its potency – see EpiPens in Sun or Snow for further details.*

Auvi-Q Epinephrine Auto-injector Case (Red)

Auvi-Q Autoinjector Case by Rescue Shot Case

  • LegBuddy by OmaxCare

  • Gourmet Getaway Mini Snack Tote

    BuiltNY’s Gourmet Getaway Insulated Lunch Sack

AimTrend All-Purpose Pocket Cinch Drawstring Gym Bag, Lime/Smoke

AimTrend’s Cinch Backpack Gym Bag

Skecher’s Sequin Backpack