Auvi-Q News, Sanofi to drop the Auvi-Q

When Sanofi recalled Auvi-Q last October, it would be fair to say that a lot of people were upset. Plenty of people preferred the Auvi-Q to the EpiPen, and it isn't hard to see why.

The Auvi-Q:

• Is smaller
• Is pocket-sized
• Talks to you

We've never carried Auvi-Qs, but that didn't stop our kids from falling in love with the testers they received at our FARE walk last summer. It was months before I stopped hearing those instructions on a daily basis. (Although on the other hand, the Auvi-Q tester is also how our son Zax learned that Epis have needles inside them, and aren't just magic devices that deliver medicine, which has led to greater Epi fear around here...)

Anyway, I digress. Just yesterday we heard the news that Sanofi is not going to be bringing the Auvi-Q back. 

http://www.in-pharmatechnologist.com/Drug-Delivery/Sanofi-abandoning-Auvi-Q-after-dosage-problems-led-to-total-recall

HOWEVER!

Here are some things you might not know (especially if you haven't read the article yet.)

• Sanofi did not develop the Auvi-Q. They licensed it from Kaleo, a pharmaceutical company founded by twin brothers Eric and Evan Edwards. Both have life-threatening food allergies of their own. The two were determined to create a better epinephrine device, and they tailored their post-graduate education to do just that.

• Kaleo is alive and well, and currently sells another device, Evzio, which bears a remarkable resemblance to the Auvi-Q. It delivers emergency medication to treat an opiod overdose. There has been no news that Evzio has had any problems.

• Kaleo has a number of options regarding how to proceed here, including producing the Auvi-Q themselves or licensing the device to another company. I'm not going to speculate as to what they'll do. It is, of course, far too soon to tell. And there's no word in this round of news regarding how the problem that led to the recall is being resolved.

But I will say this. The Auvi-Q was the flagship product of Kaleo and the Edwards brothers. The company is larger than those two, and it has grown, but at its core it came from the desire of two teenage boys to carry a better epinephrine auto-injector. It was their passion project.

The way I see it, the Auvi-Q coming back on the market is just a matter of time.

Feeding Tubes and Food Allergies

A few weeks ago, my husband's grandmother got a permanent feeding tube. At 95 years old, this was only one in a line of medical interventions addressing her declining health for the last several months.

Despite her various health issues, she has not taken this transition well. And who can blame her? Food is tied to so many of life's rituals and pleasures. Food itself gives us pleasure and no matter how limited our diet, we take pleasure from some of the foods that we can eat. It is part of our survival. We enjoy food so that we will eat so that we will live.

Her socializing is someone crippled at the moment anyway with hospital stays, but I keep thinking of how much this will impact nearly all of our interactions with her. This is a woman who loves food. A woman who is renowned in her circles for her crab salad and pear pie. A woman for whom Christmas would not be complete if she couldn't give family members homemade fudge and pecan tarts (the latter of which I, of course, have never tasted.)

This is also a woman who long ago admitted that she doesn't need more stuff, and to whom we have mostly given consumable gifts as well. Wine, Kahlua, and other alcohol; our own homemade cookies; and meals to help her out. What sort of gifts do you give a person who doesn't want more things and now cannot eat?

Not eating is even slowing her recovery. During a previous stay at a rehab center, she had 3 long walks every day on her way to and from the dining hall for meals. If she was unwilling to do any other physical therapy, she got that much exercise, at least. Now she doesn't even get that, plus she's missing out on the social time of meals.

She does get to drink a little water and try eating some easy-to-swallow foods when a speech therapist comes by, but that's all. (And by the way, the liquid nutrition prescribed to her contains dairy and soy. Just an allergy side note.)

During this time, I can't help but think about the parallels between her current situation and the lives of people with food allergies. As we all know, food allergies limit us in social situations that involve food. Getting a feeding tube just exacerbates these situations. It's like all-of-a-sudden being allergic to everything, but without the cross contact risk.

Something else I've been thinking about is that this situation just goes to show that while food allergies aren't fun (in fact food allergies can often suck) there are still many other and worse things that can happen to us. I'm grateful that our family can still eat out as long as we are careful of ingredients. I'm grateful that we have fun food rituals and can enjoy our favorite meals and desserts. I'm glad that we are all healthy so long as we avoid our triggers. I'm glad that food allergy living forces us to cook more from scratch and so we are eating healthier, more wholesome food most of the time. And I'm glad that we are learning so much about nutrition and can teach our children healthy eating habits, so that hopefully we can all remain healthy long into our twilight years.

My husband's grandmother has made miraculous recoveries in the past, so we are all hoping that she can regain her throat strength and her overall strength, and begin feeding herself again. Because no matter how allergy-friendly you slice it, food is a very important part of our lives.

Auvi-Q Recall

Troubling news just in: ALL Auvi-Q autoinjectors currently issued are being voluntarily recalled by Sanofi because of potentially inaccurate dosing. Allergic individuals who have Auvi-Qs should still use them until a replacement can be obtained, but you should contact your doctor for a prescription for a different auto-injector as soon as possible.

"The recall involves all Auvi‑Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016."

Sanofi has received 26 reports of suspected device malfunctions. No deaths are associated with these malfunctions. Sanofi is is arranging for return and reimbursement of all recalled products.

"Customers with questions regarding this recall can go to www.Auvi‑Q.com and call1‑866‑726‑6340 Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return their Auvi‑Q devices. Customers may also email cs@sanofi.com. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto‑injectors with proof of purchase."

Update: Please call EITHER 1-877-319-8963 OR 1-866-726-6340. Sanofi US previously noted that, due to the high volume of calls, callers may have received a message that the line is down. They are asking consumers to please call back and try both numbers if this happens. 

This sucks on all sorts of levels, folks. Sorry to have to report. Take care of yourselves!

"Sanofi US Issues Voluntary Nationwide Recall of Auvi‑Q® Due to Potential Inaccurate Dosage Delivery

Sanofi US is voluntarily recalling all Auvi‑Q® (epinephrine injection, USP). The recall involves all Auvi‑Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.

If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.

Auvi‑Q (epinephrine injection, USP) is used to treat life‑threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Auvi‑Q is packaged with two active devices and one trainer device in a corrugate box. Auvi‑Q was distributed throughout the United States via wholesalers, pharmacies and hospitals. All Auvi‑Q is being recalled.

Sanofi US is notifying its distributors and customers who include doctors, pharmacies, wholesalers and other customers in the supply chain by letter, fax, email and phone calls and is arranging for return and reimbursement of all recalled products.

Customers with questions regarding this recall can go towww.Auvi‑Q.com and call1‑866‑726‑6340 Monday throughFriday 8 a.m. to 8 p.m. ET for information about how to return their Auvi‑Q devices. Customers may also emailcs@sanofi.com. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto‑injectors with proof of purchase.

Customers should immediately contact their healthcare provider (HCP) for a prescription for an alternate epinephrine auto‑injector. In the event of a life‑threatening allergic reaction (anaphylaxis), patients should only use their Auvi‑Q device if another epinephrine auto‑injector is not available, and then call 911 or local medical emergency services. Customers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online:www.fda.gov/medwatch/report.htm or by Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call1‑800‑332‑1088 to request a reporting form, then complete and return to the address on the pre‑addressed form, or submit by fax to 1‑800‑FDA‑0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Sanofi US is committed to patient safety and the quality of Auvi‑Q, and will continue to work closely with customers and regulatory authorities to resolve this issue in a timely manner."

More Details from auvi-q.com

Additional Information

What is the potential or theoretical risk if the recalled product is administered to patients?

The current manufacturing issues are not related to the drug epinephrine. However, the products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction (i.e. anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition.

You say this is a voluntary recall, but did the FDA advise you to recall Auvi‑Q?

We discovered these issues as part of our routine manufacturer quality review and reported our findings to U.S. FDA. As a precautionary measure and in cooperation with the FDA, we are voluntarily recalling all Auvi‑Q currently in the market.

What should U.S. consumers do if they have this product?

People with an Auvi‑Q device are being asked to call 1‑866‑726‑6340, Monday through Friday, 8 a.m. – 8 p.m. ET for information about how to return Auvi‑Q. They may also email cs@sanofi.com. They should also immediately contact their healthcare providers for prescriptions for alternate epinephrine auto‑injectors. Details about reimbursement will be available on www.Auvi‑Q.com as soon as they are available.

Will patients have to pay for their replacement medication?

Initially, patients will need to pay for their replacement device. Sanofi US will reimburse patients for the full out‑of‑pocket cost when they receive a new epinephrine auto‑injector.

Have you alerted healthcare professionals?

Yes, we have actively been in contact with healthcare professionals.

What drug can be substituted as the replacement for Auvi‑Q?

Auvi‑Q is one of three epinephrine auto‑injectors available in the U.S. The other two are EpiPen® and Adrenaclick®.

What should a patient do if the Auvi‑Q product they have fails to work?

Please immediately call 911 or local medical emergency services for emergency medical attention. Any adverse event that may be related to the use of this product should be reported either to Sanofi US or to FDA's MedWatch Program.

Do you expect to ultimately reintroduce this product in the U.S.? If so, when?

Our focus right now is on patient safety and resolving the issues. Once our investigation is complete and we have corrected any related issues, we will announce our future plans at a later date.

A Food Allergy Lesson from a Headache

We believe that Zax gets migraines.

They haven't been officially diagnosed, but we've got the family history and they certainly fit the pattern. A few years ago, we learned to medicate him at the first complaint of a headache, because if we don't, we'll regret it when the screaming and vomiting set in.

We've also wondered if these migraines are tied to altitude and/or dehydration, because just about every time we take a trip to the mountains, he complains of a headache--and several vacations have been less fun because that's how they began.  I bring this up because Zax had a migraine yesterday when I picked him up from school.

The moment I saw him, I could tell that something wasn't right. He told me his head hurt, and as I dug through my bag for his ibuprofen, I asked whether he had told his teacher. We keep ibuprofen in the nurse's office for this very reason. He said he had told her, but she'd just encouraged him to drink more water. So of course I chatted with his teacher before we left, to make sure she understood that his headaches need to be treated right away.

When I asked if Zax had reported his headache, she said "No." All he'd said was that he was thirsty, so she'd told him to drink water. I explained about his migraines, and that I'll tell him to communicate better, but that he needs to get ibuprofen at the first sign of any headache. She seemed to understand migraines, and so I took my miserable child home.

Yesterday's headache was a doozy, and Zax threw up in the car before curling up on the couch at home for a few hours. He definitely needed earlier meds.

Looking at both sides of the story, I think that what probably happened was that he'd said "My head hurts but maybe I'm just thirsty and need to drink more water," ...or something to that effect. Out of context, his teacher probably didn't hear the first few words, and once she understood what he was saying, she just heard him report thirst. When I discussed it with Zax before bed, when his headache had, thankfully, resolved, he agreed that he'd probably said something like that. I told him that his teacher knows that he needs headache medicine now, so if he reports a headache and she doesn't respond the right way, then she probably didn't understand him. In that case, he should say it again, more clearly.

And then, of course, we started talking about his allergies in the same context. It occurred to me that the way he reports an allergic reaction may not always be clear to the teachers. Together, we discussed that if he reports a reaction and doesn't get the right response (meaning anything other than sending him with a buddy to the nurse's office) then he should say it again but make sure he says he's having an allergic reaction.

Kids don't always realize that they aren't clear to adults, and we parents don't always realize that our children's speech patterns don't necessarily make sense to people who don't know our kids as well. Just one more reason to make sure our kids speak up until they're heard if they ever have an allergic reaction!

Don't Lick the Dough!

Zax had a minor allergic reaction last night. And it was my fault.

We've been baking without egg for basically his whole life, but recently we were given the green light to start feeding him baked egg. On top of that, we've entered him into a Clinical Research Study where we've pledged to feed him baked egg on a regular schedule (I'll blog about it in detail at some point, I promise.)

Yesterday evening I was experimenting with a new bread roll recipe that had egg in it. The dough was so sticky that I needed help in the kitchen. I asked Zax to help me scatter some extra flour and get an extra baking sheet out. After he helped me, he pretended he was going to eat the rolls raw. I jokingly told him "no," so instead he ran around me and licked the dough that was stuck to the counter.

Alarmed, I told him to stop, so he started scraping the dough off with his fingernails so that he could eat it that way. I managed to prevent this and sent him off to wash his hands with the admonition that the dough had egg in it, and raw egg at that. I asked if he'd actually licked it and he said 'yes,' so I said I hoped it wouldn't be enough.

"For an allergic reaction?" he asked.

"Yes," I replied. "Or salmonella."

Sure enough, maybe five minutes later Zax reported that his throat felt funny. Benadryl resolved all symptoms within about 15-20 minutes, but still. Licking the raw bread dough.

I realized pretty quickly that this was really my error. I hadn't warned Zax that this particular dough contained egg. He's used to his allergens being in the house (not touching someone else's plate, etc) but he's never before been told he can't eat dough or batter. I don't let the boys eat it while we're actively baking, but since our baked goods never carry the threat of salmonella, my kids have never met a beater they aren't allowed to lick.

Until now.

I honestly hadn't thought about this risk in baking with egg until it happened. I also hadn't expected him to want to eat raw bread dough--but then, I seldom make bread products so he probably didn't realize it wasn't going to be sweet like pastry dough.

Lesson learned.

I apologized to Zax over dinner, for not realizing this risk and warning him about the dough I was making. He didn't seem too upset over it, for which I'm grateful.

And to top it all off, the rolls didn't even turn out that great. Zax didn't like them, which means I'll be baking (with egg!) again today.

*sigh*

A Pleasant Surprise

As I mentioned a few weeks ago, we discovered that Zax's threshold for egg white was a whopping 21 mg (3/1000ths of an egg) after entering him in a study at National Jewish Hospital. Entering that study was a long and involved process though. We'd been directed to them from the administrator of a different study--one that would aim to desensitize Zax to his egg allergy by various methods of OIT therapy. His high history of reactivity in the past seemed like he wouldn't be eligible for the OIT study, so they suggested we try the other one first.

In order to be eligible for the OIT study, Zax would need to react before 1,400mg of egg white (no problem) but also be able to tolerate 1/3 of an egg (roughly 2,000-2,333mg) in baked form.

Zax failed his baked egg challenge when we tried it prior to entering preschool almost three years ago. I anticipated that he would again, but then I found out that our allergist likes to challenge baked egg every two years because that tolerance can change. We also had an incident at a restaurant where Zax might have eaten a hot dog bun containing egg with no reaction, but we didn't know for sure. There was still a chance to get Zax in the OIT study, so we decided the time was ripe for another baked egg challenge.

I'll admit that I fully expected him to fail, but the challenge would be in a safe environment and it would be useful to know one way or the other--plus I really wanted a crack at trying to desensitize him--avoiding egg is HARD!!! So we went ahead and tried a baked egg challenge in our Allergist's office.

And you know what? HE PASSED!!!!!!

It really seemed to be by the skin of his teeth, though. They divided the muffin dose in quarters, taken at 15 minute intervals. He said his tongue felt funny after the first dose, and I figured it was over, but when I asked him if it felt the same as his confirmed reaction at National Jewish, he said no, it was different. Then he felt better in a few minutes. The nurse suggested we press on, because it really was worth it to know one way or the other. Zax was

reluctant, but I assured him that they had all the medicines to take care of him if something happened and if it was a reaction, it would get a little stronger and then we'd stop. He agreed to eat a half-size dose again, but with frosting.

Playing with the Food Challenge room toys. What is the
allure of little-kid toys for older kids?

About five minutes later, he said his mouth felt completely better and maybe the frosting made it go away! I said maybe it just meant that he'd been nervous. He happily played and completely acted like his normal self after that, further confirming the "nervous" diagnosis.

To my complete surprise, he continued to do well for all the subsequent doses. Considering how quickly he had reacted the last time we tried baked egg, and how quickly he reacted to his food challenge at National Jewish, I was flabbergasted. By the time he'd completed 3/4 of his full dose, I texted my husband that I was feeling very optimistic. This was farther than he'd ever been before, and it was progress even if he didn't fully pass the challenge.

About five minutes after his final dose of muffin, he reported that the back of his throat felt just a teensy bit achy. I asked if that was the same feeling as from his reaction at National Jewish, and he said Yes. We told the nurse and she examined him, but except for a red mouth from the red frosting (a potential issue that hadn't even crossed my mind when I grabbed the frosting I already had in the fridge) she didn't see any physical symptoms. We continued to wait, and maybe 10-15 minutes later he reported that his mouth felt fine again. And he never crashed the way he did at National Jewish--he continued to run around the room and play with all the toys with his usual energy level.

The nurse declared it a Pass, and said that if he were reacting to that 4th bite of muffin it would have gotten worse, not resolved on its own. I don't think that's quite right though. I think it's more likely that we just barely touched on his baked egg threshold. He got enough to barely feel it, but his body was able to metabolize it and move on without drugs. I've had reactions like that, where I've tasted just enough to know that I shouldn't eat it, and the feeling went away within minutes. So I'll be starting at a lower dose at home, just to be safe.

Something I've learned is that my son is a trouper when it comes to his allergies. He can ramp up the anxiety pretty high for a lot of things (going on boats, putting his face in the water--pretty much trying anything new) but he's never thrown a fit or completely refused or run away from anything I've asked him to do to study his allergies. We've explained that we need information, that he'll be safe, and that we and the doctors will take care of him if anything happens, and he's trusted me and done what we've asked, even when it has involved uncomfortable things like needle sticks and eating things that might hurt him. I don't think about it when my son is freaking out about swim lessons, but he's a very brave boy and I'm very proud of him!

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This is a whole new world and I'll confess that I feel somewhat adrift. I know the parameters for what we should offer Zax at home, but how does that apply to things baked outside my home? How do I determine if another child's birthday cake meets the parameters? How about breads, do they meet the requirements? How about bakery cakes and cookies (although those often carry CC risk from nuts)? How about processed foods like snack cakes? What about breadings on fried foods? Are egg pastas cooked enough to qualify? How will this affect our restaurant ordering? How about candy (like the nougat in 3 Musketeers)? I didn't even think of most of these questions until we were home, so I have yet to ask an expert. The only thing I know for certain is that I'm no longer concerned about cross contact with baked goods containing egg--and that's nice, but only one small element.

Of course, the answers to these questions are probably not definite, they depend on the sensitivity of the individual. And they may all be moot, because now that he's passed a baked egg challenge, we're pursuing the OIT research study that I first learned about months ago. And if he qualifies for that, life will have to go on as it has been, with the only egg or baked egg that he eats being his dose for the study--for the next two years.

There are a lot of unanswered questions in our future, but we're at a point I hadn't really thought we'd reach. We CAN ask these questions, we CAN consider these options, and right now, that feels pretty good!

Inside a Food Allergy Study

21 lousy milligrams.

That's all the egg protein it took to induce an allergic reaction in my eldest son. It wasn't anaphylactic at that level and was controlled with antihistamines, but I can't help but shake the feeling that this is very allergic. 21 milligrams. That's 3/1000ths of an egg, folks!

Not many people know a specific threshold for themselves or their allergic little ones. The reason we found this out was because of a research study. We enrolled Zax in a study at National Jewish Health in Denver to study a new blood test for food allergies. From what I understand, the hope is that the new blood test will not only be more accurate, but may also predict severity.

We're offering a special discount just for the holiday weekend!

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Day 1
It was an interesting process. The first day was a screening visit to make sure he was eligible, get his specific numbers, and take blood samples. They were specifically studying egg, milk, and peanut, and Zax is allergic to two of the three.

We started out by putting a numbing cream on his arm (which takes a while to take effect) and then we talked a lot. They took a medical history and did a scratch test for egg and peanut. I liked the way they recorded the numbers from the scratch test--they traced around his reaction with a fine-tip sharpie, then took a piece of packing tape, placed it over his reaction, pulled it off, and then they had an exact copy of the size and shape of his reaction. Very nice way to remember exactly how things went when they come back to his chart months from now.

His histamine control reacted, as it was supposed to, and so did peanut, but egg failed to show up. Suspecting that something was wrong, though, the doc reapplied the egg prick and reset his timer.

No such luck, egg popped up after all. I almost got my hopes up here, but not too much. I, too, suspected that something was wrong with the test and didn't really think his egg allergy had just disappeared. We were there for the egg, after all. They had met their study quota for peanut participants prior to our learning of the study. We first thought we could be grandfathered in since we were already in the study for egg, but later found out that doing peanut wasn't possible.

After the skin test was complete, they did a blood draw. Despite the EMLA cream, Zax said it still hurt. Poor boy. A previous blood draw had gone fine, but this one was uncomfortable in some way. He was brave anyway!

They took his vitals too, and did pulmonary function tests so they would have a baseline for later.


After his initial screening Zax did two double-blind food challenges. In both cases he ate applesauce seasoned with cinnamon and spiked with either egg protein powder or oat powder (placebo.) Neither we nor the staff knew which day was which until he reacted.

They weren't just interested in whether Zax would react, but also at what dose he would react, so they carefully gave him graduated doses at 15 minute intervals. The doses were as follows (measurements are in milligrams of egg protein powder or oat placebo.)

1, 5, 15, 50, 75, 100, 250, 500, 1000, 1250, 1750, 2250, 2750 = 9,996mg grand total (almost 10 grams if all doses are ingested)

For each day, we were scheduled for about 5 hours. The doses took 3 hours to administer (assuming he got through them all) and then we would hang out for a 2 hour waiting/observation period. If, on the other hand, Zax reacted, we would wait for observation for 2 hours following a reaction requiring Benadryl and 4-6 hours following a reaction requiring epinephrine. So 5 hours was more of a ballpark, it could be as few as 3 or as many as 7-8, depending on reactions, severity, and how far into the challenge he got before reacting.

Day 2

National Jewish has a dedicated Food Challenge Room in the Pediatric Department. This was pretty cool, because it was equipped with all sorts of activities to keep the kids occupied. We brought a backpack of toys and books along to keep Zax busy, but apart from his kitty we didn't even open it on day 2. They had movies, a Wii, toys, and crafts galore (Zax LOVES crafts, so when they called for the craft cart, he was in hog heaven!)

We started the day by getting his vitals again (and he took kitty's vitals) and then the eating began! I had explained what we were doing to Zax beforehand, several times, but we went over it again after his first dose. He wanted to know why we were coming twice so I attempted to explain the purpose of a placebo to a six-year-old. The moment I told him that it protects against him getting worried and thinking he feels a reaction when he doesn't, he pointed to his throat and said it felt a little funny. We reported that to the doctor, who suggested that he take a sip of water to see if it goes away. He did, and then buried himself in crafts, and nothing further came of it. Apparently describing the placebo effect is enough to cause a placebo effect.

There were two other boys in the the Food Challenge room (with their mothers and doctors) because the room was shared. Zax enjoyed playing with the younger of the two, who was challenging peanut for the same study Zax was in. The third boy was doing his one-year challenge for a peanut patch study--and he was getting near-constant attention from the staff. Both of the boys challenging peanut had an IV hookup in their arms so they'd be ready to administer steroids or fluids if necessary, which is hospital procedure for peanut challenge.

Before each new dose, the doctor and nurse checked Zax over, listened to his lungs, had him perform a Peak Flow test, and asked him how he felt and if he had any itchy spots.

After about 8 doses, I started doing math. I'm a numbers person, so I naturally gravitate towards them. I copied down all the doses, added up what Zax had eaten so far, calculated how much egg had been required for Zax to react previously, and thought about what all of that meant.

You see, Zax did a baked egg challenge before starting preschool, which he failed. I'd been told at the time to bake something containing 2 eggs, baked at 350 degrees for 30 minutes, and to bring in 1/12th of it. The nurse then cut the brownie I provided into four equal parts, and we fed them to Zax at 15 minute intervals. Zax felt a little funny after eating the first quarter (1/24th of an egg) but didn't report it because he wanted more chocolate. He no longer wanted any brownie after his second piece (1/12th of an egg cumulative.) If an egg is 6-7,000mg of protein, that meant that he'd started reacting at no more than 291mg, and he called the test quits at 583mg. At the time that I started calculating all of this, he had eaten 996mg of something--egg protein or placebo. I began hoping very fervently that day 2 was egg, because if it was, that would be a very good sign!

When given the option, my kid can cram a lot of crafts
into one day!

He kept eating each successive dose without issue, however, and after he ate a combined dose of more than half an egg (if it was real) I came to the conclusion that he'd been eating placebo. Zax loved the applesauce and eagerly scarfed down each dose without any issues. The room was fairly noisy and boistrous, and it became apparent after a while that all three of the kids were taking placebos that day. A random assignment to be sure, but it was nice to have everybody on the same page.

There was no eating during the test (except for the study doses), but after all doses were taken Zax was allowed to snack on foods that are safe for him. He did so, and we waited out our observation period with more crafts, games, and movies.

I didn't tell Zax that I was certain what he'd eaten was the oat powder. I told him that either it was the placebo or he'd outgrown his egg allergy. He'd approached the challenge with such confidence and enthusiasm that I didn't want to damper that with the expectation that he would definitely react at the next challenge, even though that was fully what I was expecting.

You may have noticed that Zax was wearing his "Eggs are my Nemesis" shirt for the challenges. It seemed fitting. Check out our website for gear like this to protect your little allergic superheroes!

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4th of July weekend only!

Day 3

Zax's second challenge was four days after his first. I reiterated to him that nothing might happen that day, although when taking his first dose he told the nurse he expected it had egg in it. There was one other boy doing our study that day, accompanied by his mom and sister (who had no allergies.) The two did not get along as well, so they did not play together much, although they watched TV together.

Zax selected a craft to do and got down to work. He didn't get very far, though, because a few minutes after his third dose he told me that his throat felt funny, kind of achy/itchy. We reported this to the doctor and nurse right away.

The doc has a sense of humor, which you can see from his
shirt. He said it was a graduation gift from medical school. It says:
Allergy Information:  This shirt contains a Nut

They took his peak flow, listened to him, and asked him questions. Then, just like the previous day, they asked him to take a sip of water to see if it would make it go away. Then they told me that they'd wait a bit longer and see how he's doing before deciding if they'd do the next dose.

After maybe 10-15 extra minutes he said his throat felt mostly better so they gave him his next dose, another 50mg, bringing him to 71 total. I felt certain that the challenge would end there, but after another 15 minutes he said it still felt about the same--not totally gone, but no worse than before. So they gave him dose number five, 75mg, which brought him up to 146mg total.

Just a few minutes after that dose, he said his throat felt worse again, and worse than before. While he'd been hesitant and wanted me to report his symptoms to the doctors previously, this time he boldly told them himself, and announced that he didn't think he should eat any more. They checked him over and still didn't see much in the way of physical symptoms except possibly more stuffiness in his nose (he'd already been stuffy from seasonal allergies because he couldn't take antihistamines prior to the challenges) but everybody agreed that he should stop.

I know what they were doing when they pushed him to five doses from three. My kid had experienced a mild placebo effect on the first day, on the first dose, and as part of their study procedure they have to make sure that a patient is actually experiencing a reaction and not just a tickle in their throat or a placebo reaction. I do get that. But since the feelings never completely went away and then returned more strongly after the next few doses, there's no doubt in my mind that he was feeling a reaction on dose 3, after eating a cumulative 21 lousy milligrams. No doubt. And if he's going to react to 3/1000ths of an egg, I don't feel like he's going to grow out of this anytime soon.

We gave him a meltaway Zyrtec, which greatly surprised me. When the doc suggested it over Benadryl because it wouldn't make him sleepy, I couldn't help but grill him. Is it really as effective? I'd never considered or even heard of using a once-daily antihistamine in place of Benadryl. He said it hasn't been rigorously studied but from what they've seen, liquid or quick-dissolving Zrytec (and possibly Allegra) works as well as Benadryl for mild reactions. Zax was already starting to get drowsy from the reaction, so I decided to give it a shot rather than give him a drug that would make him even more tired.

After about 40 minutes Zax reported that he felt all the way better, but a few minutes later he gulped a bit and said he might throw up. He didn't, but he sat with the throw-up bucket nearby while staring mindlessly at the TV for another half hour or so.

Once he started to perk up, I broke out the consolation prize--a new Lego set. We even found a better use for the throw up bin!

I realized after the fact that I'd been taking pictures through the whole procedure, but I hardly took any while Zax was reacting. Too preoccupied with my child's welfare to think of the camera. For a while he looked really run-down, with bloodshot eyes and circles under them. Once all of that cleared and his behavior perked back to a semblance of normal, I knew he was feeling better.

By the time we left, Zax was basically himself but still a little worn out. It's rough to have an allergic reaction, even if it isn't anaphylactic. Especially if you ate more than you probably should have. He was tired all afternoon and didn't have his normal energy level again until the next morning. I'm happy to report that the next morning wasn't at all affected by the reaction, and he played soccer without a hitch. We had Epis on hand as per doctors orders (which we always do anyway) in the time following the challenge just in case of a biphasic reaction, but fortunately he was fine.


It was weird intentionally inducing an allergic reaction in my son. I was never scared for his life--after all, there's no safer place to have an allergic reaction than in a hospital surrounded by doctors who do this all the time--but I was worried about him, especially going into Day 3. Even though there had always been a chance that he'd react to the first challenge, it somehow felt worse the second time, and probably because I knew that something was going to happen that day. I was doing my best not to pass anticipation or anxiety on to him, and I think I succeeded, but that doesn't mean it was easy.

I am glad, however, that we're contributing to the advancement of food allergy science. This new blood test may someday replace RAST testing, or it may fizzle and die off, but we're helping determine if it works, and that's a worthwhile achievement.

There was one silver lining to Zax's reaction, other than the obvious contribution to medical science. I quiz him regularly on what he's supposed to do during an allergic reaction, and I introduce different scenarios for him to think through. A few months before this study, I asked him if he remembered what an allergic reaction felt like and he said no, not really. Then he suggested that maybe he should try something he's allergic to again so he can remember.

I am a fan of knowing what you're dealing with. When I first read the story of B.J. Hom's death, I couldn't get past the detail that he asked his father for cough drops because his throat hurt. He didn't know he was having an allergic reaction, and so neither did anyone else in his family. I was stunned than anyone with food allergies could make it to the age of 18 without knowing what an allergic reaction felt like--because my own childhood was riddled with accidental exposures that, among other things, didn't allow me to forget that telltale sensation. So the fact that someone could die of an allergic reaction because they didn't even recognize what was happening scared me. A lot.

It scared me so much that it has colored the way I parent. Every time one of my kids has had an allergic reaction, I've asked them to think carefully about how they feel and to remember it, and if they ever feel that way again, they're to tell an adult right away. Because really, none of the words we use to describe an allergic reaction quite does it justice. They're close, and good guides to be sure, but it's a unique feeling that lacks an appropriate descriptor.

So there was Zax, at the wise old age of 6, admitting that he didn't remember an allergic reaction (it had been a few years) and suggesting that he needed a reminder. This study certainly gave him that reminder, and there was no safer place to do it. And if that experience can keep my child safer, then it was time well spent.

Why are we so upset by the LEAP study?

Not long ago, we all heard about the landmark LEAP study, which found that if we introduce peanut products to at-risk babies early, we may be able to prevent peanut allergies in the majority of them.  But far from celebrating this breakthrough, much of the response from the food allergy community has ranged from lukewarm to downright hostile towards the study.  Many cautioned that feeding peanuts to babies was far too dangerous, or even doubted the study results because it couldn't have applied to their own children.

Any time a study on food allergies gets published, the media latches on to it like a pit bull, but only onto the most sensational details.  Probiotics help OIT therapy have a higher success rate?  "News Flash!  Yogurt cures peanut allergies!"  Feeding peanuts to high-risk babies lowers their chances of developing a peanut allergy?  "Feed Peanuts to Your Infants Now and they'll Never Have Allergies!"  Or worse yet, "Eating Peanuts Cures Peanut Allergies!"

The backlash from these headlines hits the food allergy community every time.  Well-meaning (and not-so-well-meaning) friends, family members, neighbors, churchgoers, school parents, and random strangers on the playground want to share the great news with us, or just tell us how we did it wrong.  When their understanding is incomplete or skewed, that can do a lot of damage.  We worry that the parent volunteer in the classroom may give our child a peanut just to "prove" that we have nothing to worry about. We worry that we'll receive less sympathy because people think we're withholding The Cure from our kids.  We get tired of hearing about how everybody who doesn't have an allergy did things the "right" way, and we should have done it that way too.

I think this is one of the big reasons we've been so upset by the LEAP study:  everybody who saw a news story or read a headline is now an expert on peanut allergies.  They can't resist sharing their voluminous knowledge-base with us.  Dealing with food allergies is hard enough, we don't want lectures from the uninformed on how allergies work.

Even more irksome than the media backlash, though, I think is the heavy dose of guilt that came with the LEAP study.  If feeding peanuts to infants can prevent peanut allergies and we didn't try it, the implication is that we caused preventable peanut allergies in our children.  Some media outlets and blogs went farther, outright stating that parents are to blame for peanut allergies.  Our population is already vulnerable--we're always wondering if we did something wrong with our children.  (Should we have avoided peanut during pregnancy?  Eaten more peanut during pregnancy?  Avoided peanut while nursing?  Washed our peanut-contaminated hands before handling our infants?  Vacuumed better or more often?  Done all our dishes by hand?  Used less antibacterial soap?  Let our babies eat dirt?)  The implication that yes, we did do something identifiably wrong and caused our children's allergies rubs us the wrong way. And understandably so.

But how about those who did expose their infants to peanut, whether intentionally or unintentionally?  There seems to be an equal amount of malice there, and I think it may be part indignation that the system didn't work for them.  I stated before, and I will repeat it now, that nothing is ever one-size-fits-all.  Some babies were eliminated from LEAP because skin tests showed that they likely already had severe peanut allergies, and LEAP was looking for a way to prevent allergies.  What this shows is that while early introduction of peanut has now proven beneficial, it cannot work for everyone.  And it is ONLY a preventative measure and does nothing for those who already have an allergy. Unfortunately, some people are going to develop allergies no matter what.  I'm not interested in speculating about what the causes are, although I am sure they are many and varied.  As always, I see the LEAP study as one piece of a very complicated puzzle.

I think our biggest beef with the LEAP study is that it isn't a cure.  It's a groundbreaking discovery, but it doesn't benefit anybody currently in the food allergy community.  And the people who are spared won't even appreciate it.  They will never know the terror of rushing their swollen child to the ER while watching him struggle for breath, so they'll never understand what pain they've been spared.  They might say "I'm so happy that my child doesn't have any food allergies," but that's nothing compared to the relief a food allergy parent would feel if their child were magically cured.  Those who may best appreciate this are limited to the food allergy parents who are still having babies.  And those parents are naturally wary of feeding one child's poison to their new child.

And poison is how many people have come to think of peanuts.  We get offended any time the peanut industry introduces a new product.  When considering that peanuts may kill our children, we become accustomed to seeing peanuts like this:

The peanut is our child's enemy, and so it becomes our enemy.  And anyone working in the industry becomes a minion of that enemy.  It's natural to feel this way, and to feel conflicted about our previous enjoyment of this nefarious substance.  But I encourage our community to remember that to most of the world, the peanut is just another food.  If you think back to your pre-allergy days, you didn't see anything harmful in a peanut, either.

I've seen a lot of the sentiment "Wait!  Don't try this at home!" in regard to the LEAP study, and I think it's largely because of this image.  Everyone is advocating for how dangerous peanuts can be to babies, but let's think about that.

First of all, peanuts and peanut butter are definitely choking hazards for infants.  So if peanuts are to be fed to babies, we need a safer delivery method.  The Bamba snack used in the study seems to fit the bill for babies ready for finger foods, and I can think of a handful of other items that could be used for the same purpose.  Those wishing to feed peanut as one of the earliest foods would have to get more creative in finding a way to incorporate it into a baby-safe puree--that is, until the peanut industry creates their own line of peanut baby food, which I'm sure they will.  I just hope that baby food companies will keep it in dedicated facilities, keeping other baby foods clear of cross contamination. Many babies will still develop allergies, after all.

So should people start feeding peanuts to babies?

I won't kid you, I'm not a doctor.  I am neither pediatrician nor allergist, and I will leave infant feeding guidelines in the hands of experts.  But I will mention that I discussed this study with our allergist days after it was released.  She reminded me that they've found no benefit to avoiding peanuts and other allergenic foods in babies who are not considered to be at risk for allergies, and they have not recommended avoiding in those populations for a few years.  My kids were automatically at risk because they are my kids, so they had the genetic strike against them already.  But in families with no risk factors, and where the infants have not developed eczema or other allergies, there's nothing to indicate that parents should wait.  Allergies do crop up among populations that had no risk factors, however, so it's wise for all parents to be aware of the symptoms of an allergic reaction and be prepared to act.

As for babies in higher risk categories, our allergist seemed to think that the recommendation of early testing and possibly supervised feedings might be in the forecast.  Absolutely, everyone should consult with their individual doctors regarding feeding advice.  But I hope that people, particularly parents whose older children already have allergies and who are having more babies, won't dismiss this study.  It has huge implications for a future with fewer allergic children. J

Allergy Study

Zax and I participated in a food allergy research study last week!

As studies go, it was quite simple. We gave some preliminary medical history over the phone so the doctor could decide if he wanted our blood.  Once he decided that he did, we came in. From there, it was a simple questionnaire about our allergic history and a blood draw.  Easy Peezy!

Our Peanut Allergy Slap Bands are available now!!
Click here!

Zax has never been all that good with needles, so I started prepping him a few days before.  I told him that the study doctor wanted to try to figure out why people have allergies, and since we do, our blood can help him figure that out.  I also told him that maybe someday the information the doctor learns from our blood might help find a cure. Zax needed the word "cure" defined, and as soon as I finished doing that he exclaimed "I want that!"  This still makes me smile.

We had to do our blood draws in different places.  The study was through the University of Colorado Anschutz Medical Campus, but they only draw blood for people 12 and up there.  The study accepts kids as young as 6 with peanut or tree nut allergies (Kal is still too young to participate) so they shuttled us over to Children's Hospital for that.

I went first because I wanted Zax, who again isn't very good with needles, to see what was in store. He watched the tech take my blood and took these pictures of the process.

Once we got over to Children's, they gave Zax some numbing cream on the crook of his elbows--both sides, just in case they had trouble with the first side.

I was anticipating having to help hold him still because of how he's been with shots, but he did GREAT! I held his hand while the nurse put the actual needle into him, but after that he allowed me to let go so I could take pictures of him.

I came over to rub his back a few times, but he was absolutely fine.  The only thing he complained about was the tightness of the tourniquet.  I was so proud of my little superhero! I don't know if it was the early prep, the numbing cream, the fact that he knew he was helping people and trying to find a cure, or just that he's getting older, but this is definitely the best that I've ever seen him around needles.  I love my brave kid!

We were very happy to help contribute to this!  Have you ever participated in a research study?


As a matter of fact, this study is still looking for participants.  They have enough controls (non-allergy people) but if you're in Colorado and have a peanut or tree nut allergy, or know anybody who fits that criteria, I hope you will consider participating!

Here's the info, if you are interested:

PEANUT AND TREE-NUT ALLERGY RESEARCH STUDY

Blood Samples for the Study of Peanut, Tree Nut and

Other Food Allergies

COMIRB # 13-2102

We are seeking adults and children who are allergic to

peanuts and/or tree-nuts to donate blood. And

individuals with no known food allergies.

Description: The purpose of this study is to determine how the body’s

immune system interacts with nuts and other foods to cause allergic

reaction.

To be eligible, you must be:

1. 6-75 years of age

2. Have a diagnosis of peanut and/or tree-nut allergy made by either skin

tests or blood tests.

3. Have no known peanut and/or tree-nut allergy.

Participation will include:

1. Donation of a small amount of blood

Financial compensation will be provided after participation in the study.

For information, please call

Spodra Eglite study coordinator

303-724-7193

Principal Investigator: Stephen Dreskin, M.D., Ph.D.

Co-Principal Investigator: Dan Atkins, M.D.