The Auvi-Q Effect: The Recall, The Reverberations, The Rebound

Sanofi Recalls Auvi-QManaging food allergies, where one tiny contact with our allergens can have huge consequences, has left me keenly aware of what is known as the butterfly effect.

According to the Meriam-Webster Dictionary, the butterfly effect is “a property of chaotic systems (as the atmosphere) by which small changes in initial conditions can lead to large-scale and unpredictable variation in the future state of the system.”

When the Auvi-Q first hit the market, I must say it soared in, hot and shiny. With its relatively smaller size, faster delivery and voice activation, I felt myself breathe a little easier.

As opposed to looking like a big needle that they say we need to swing into the thigh, its credit-card-like size and the promise of a helpful voice to walk me through the scariest emergency of our lives gave me a sense of comfort.

But now I know it likely was a false sense of comfort. And the repercussions of what could have happened are frightening. Sometimes when something is too good to be true, it unfortunately is.

So when the maker of our formerly beloved Auvi-Q epinephrine auto-injectors, Sanofi US, in an Oct. 28 press release issued “a voluntary nationwide recall of ALL Auvi-Q due to potential inaccurate dosage delivery,” the food allergy community was hit with a huge blow.

In many ways, on social media, I felt like our dear community imploded and exploded that night. For many food allergies families who made a total switch to the Auvi-Q (as mine did), things truly became chaotic.

Recall Leaves Many Scrambling

The Auvi-Q has been one of the epinephrine auto-injectors available for treating life-threatening allergic reactions, or anaphylaxis. It has been a blessing for many of us food allergy mamas and papas due to its conveniently smaller size as well as its comforting voice that talks you through the steps for epinephrine delivery and faster, five-second administration.

So we switched to it. We practiced with the trainers that come with it. We did role plays with it. We gave it a nickname: our “stamper.” We trained our teachers and friends with it. My husband finally never asked if he “had” to carry them to the nearby playground, as he did with the Epipens. And we forgot about the bigger epinephrine auto-injectors we used to rely on.

To be honest, when I first saw the announcement on social media, I thought it was a prank. But sure enough, after visiting their site, my heart sank and the nerves and confusion began to kick in.

I didn’t realize how much of the past six years of my life have depended on that little device until the moment I read Sanofi’s press release for myself. I was left scrambling that night, because we no longer have Epipens–or even an Epipen prescription. We had switched completely to the Auvi-Q for both home and school.

I imagine allergists, pharmacies and many schools have been swamped. I not only immediately contacted my allergist for a new Epipen prescription, but also called our pharmacist (who had just learned about the recall from another food allergy mom).

What was equally nerve-wracking was that everyone who had Auvi-Qs along with Epipen scripts was calling that night to make the switch. The fact that I had to wait until the next day for a new prescription left me (correctly) worried Epipens would be back-ordered and unavailable.

Even now, four days later, we only have two of the five Epipen packs we need for ourselves and our school. Another huge issue is that our school still won’t accept what we do have, because our allergist still hasn’t rewritten and signed a new allergy action plan giving the school permission to give my son the Epipen as opposed to the Auvi-Q.

Believe me. On the day before Halloween with parties and parades going on at the school with my son’s allergens in tow, I wasn’t feeling good.

What Exactly Has Been Recalled?

What also was upsetting that night was the confusion. I consider myself to be pretty good at reading press releases because I used to write them, but I wasn’t 100 percent clear whether ALL Auvi-Qs were recalled or just the lot numbers highlighted in the initial press release.

The pharmaceutical company has since confirmed that ALL Auvi-Qs have been recalled. It also confirmed that the recall involves all injectors currently on the market, not just the originally highlighted lot numbers.

These lot numbers “include every consecutive lot number beginning with 2081278 through 3037230,” it said in its edited Oct. 29 release.

Moreover, as many food allergy friends have pointed out and the press release specifies, it is not a defect in the mechanism but rather a potential “dosage delivery” issue. That initially made me feel better, because I told myself if something happened and  there wasn’t enough epinephrine in the first Auvi-Q, I would use the second.

However, I just read on SnackSafely.com that according to a recent Dow Jones News article, a Sanofi spokesperson said the Auvi-Q devices in question “potentially delivered too little epinephrine or none at all.”

Yikes. I guess as food allergy parents we can play out in our minds the “what if’s” but we really just have to move forward and focus on what we can do about it now.

What If I Don’t Have an Immediate Replacement?

So I’m quite nervous that everything won’t line up in time and my son will be at school another day without immediate access to his Epipens. I know our school thankfully has stock epinephrine in the form of Epipens now, but there’s a reason quick access to epinephrine in the classroom emergency bag and in his backpack on the way to school is advised: EVERY SECOND COUNTS.

I’m sure Sanofi is doing everything it can to figure this out for us. It’s just a shame this happened.

And it’s a shame we couldn’t have known earlier, so we all would be equipped with our alternate epinephrine auto-injectors on Halloween–a day that already is super scary for families managing food allergies because unfortunately many children are around more of their allergens.

I’ll be honest. After six years of planning and preparing for allergy-laden holidays, before the recall, I’d been feeling somewhat confident about Halloween this year. But I definitely took a few steps back.

At least I did have two Epipen packs by the time trick-or-treating was upon us. But I still felt less prepared, because I’ve been training for so long with the Auvi-Q.

Taking Steps to Move Foward

Too, many of us have to tell our children that the “stamper” we’d been playing up for so long will no longer be with us. It’s no longer part of our emergency action plan. Many of us have to reintroduce this larger Epipen.

Now please don’t get me wrong, I’m SO very thankful for the Epipen. Especially now. And I admit that I do feel guilty for not being more steadfast over the past year, as if I cheated on it.

But these little wrinkles in our allergy action plans inevitably make us and our children a bit less certain. We have to start from scratch–delicately. A lot rides on how we reintroduce a new plan and train again.

For those who are old enough to self-carry, especially teens, this may involve finding new carriers and figuring out how this larger auto-injector can be hidden underneath our clothes, for example.

I know we can all do it. And thank goodness we have an alternate epinephrine auto-injector to turn to. But for a few moments or days, if you’ll excuse my language, all hell broke loose in the food allergy world. And rightly so; these auto-injectors can save our lives if used properly.

Helpful Food Allergy Community Resources

What got me through that first night and was so helpful the following morning was the outpouring of support from the food allergy community on social media and in my inbox. And actually, social media is how most of us found out about the recall.

I also think it’s wonderful that despite this blow, the food allergy community recognizes that the Auvi-Q is a brilliant concept and continues to support Sanofi as it figures out what went wrong. There is even a pledge going around showing everyone’s support.

The food allergy community knows how important epinephrine auto-injectors are. Having a choice between what brand works for each family is valued and appreciated.

So while some people of course may be hesitant to or even won’t go back to the Auvi-Q, others aren’t turning their backs and instead are saying, “What’s done is done. We have your back. Let’s work together to improve the safety and efficacy of what could be a wonderful product for our community.”

I’m hopeful answers will be found and Sanofi will show us that their new Auvi-Qs will deserve our trust once again.

Until then, this is a good opportunity for us to show Mylan, the maker of the Epipen, that we truly appreciate everything they do for us.

Moving forward, here are some resources I’ve been so grateful for that continue to give me more answers:

Allergic Living

Caroline Moassessi at Gratefulfoodie.com

Food Allergy Research & Education (FARE)

Gina Mennett Lee with Mennett Lee Food Allergy Consulting

Homa Woodrum at Oh Mah Deehness! 

Kids With Food Allergies (KFA)

Kristin Beltaos with A Gift of Miles

Sharon Wong at NutFreeWok.com

SnackSafely.com

If you still have questions, keep checking back. I will be adding more helpful resources, sites, updates and blog posts as I see them.

And for all of my fellow food allergy mamas, papas and friends scrambling to get safe epinephrine replacements, reimbursements, new action plans in place and a return to the foundation of training and readiness we had, I hear you. Deep breaths. We can do this–together.

Please note the recall is for all Auvi-Q and Allerject brand epinephrine auto-injectors in both the United States and Canada. Please visit Sanofi US for more specific information on reimbursement, what hotline numbers to call, etc. Too, don’t forget to refresh yourself on the Epipen, its differences in administration, etc. If you have any advice or comments, I’d love to hear from you!

2 Responses to “The Auvi-Q Effect: The Recall, The Reverberations, The Rebound”
  1. Robin

    What a week indeed! Great post and thanks for sharing. Your whirlwind experience sounded a bit like ours….thankfully I still had some not-quite-expired-but-almost epis still around to give me a little comfort for the 2 day wait, but if we sit too long and think about the “what-ifs” over the last year–wow, that’s crazy–best not to think too deeply about it. We thought we were covered but thank goodness we had no issues! I’m still hoping Sanofi figures out what’s going on–I am happy for the epi-pen, but can’t imagine Sanofi won’t figure this out and get it right, so we can use this great little device moving forward. And you wonder why Mylan isn’t working on something smaller, and similar for us to use as an alternative too?

  2. Christina Black

    Thanks for the wonderful article. I think the food allergy community responded very quickly and well.

    I wanted to hear more from Sanofi and from the FDA. I think the recall notice was very poorly worded, as I was left thinking my son’s expired Auvi Q devices were OK. I don’t know that I would ever trust a device from them again. Any manufacturer should be doing random testing and quality control. Were they not ? They are innovative but irresponsible.