Lessons from the Auvi-Q Recall

We do not use Auvi-Q, but my heart goes out to all those affected. Here's some things I've learned as this recall proceeds.

Have two types of epinephrine injectors at all times.

We have more than one set of epi-pens, but not more than one brand. This recall could have just as easily been for epi-pens. When the fervor has died down (so I am not getting an injector someone needs), I will be contacting James's allergist and asking for a prescription for Adrenaclick, which my insurance also covers. 

Replace your Auvi-Q as quickly as possible.

But, in the meantime, continue to carry your Auvi-Qs. They have reports of 26 device malfunctions and "In these reports, patients have described symptoms of the underlying hypersensitivity reaction." I looked up "hypersensitivity reaction" and it is an abnormal immune response. So, basically, the device did not inject enough epinephrine and the reaction continued. Until you can replace your Auvi-Q, I would carry whatever supply you have and, if necessary (as always), give multiple injections until the reaction stops.

Here is a link to the coupon co-pay for epi-pens: https://www.epipen.com/copay-offer/

Here is a link to the coupon for cash paying customers for Adrenaclick: https://webrebate.trialcard.com/coupon/EpinephrinePortal/

Remember that the app, GoodRx, will tell you where the prescription is the least expensive.

Get your Information Directly from the Source.

This is easier said than done. As I understand it, Sanofi has been very hard to get through to on the phone. And, whoever writes Sanofi U.S.s press releases needs to look for a different job. However, because the information was initially muddled, there were lots of stories making their way around social media. The only way to be confident in your information is to contact Sanofi. Here is a link to the Auvi-Q website https://www.auvi-q.com/ . There is a warning message on the home page that callers may get a message that the phone has been disconnected due to high volumes of calls.

What has Sanofi Said:

From the U.S. press release:

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.

There is obvious confusion on whether all Auvi-Qs have been recalled or only the ones with the mentioned lot numbers.

From the Canadian press release (Allerject related): 

"Sanofi-aventis Canada Inc. (Sanofi Canada) is recalling all Allerject® (epinephrine injection, USP). The voluntary recall involves all Allerject currently on the market and includes both the 0.15 mg/ 0.15 mL and 0.3 mg/0.3 mL strengths for hospitals, retailers and consumers."

Note that there is no mention of lot numbers.

Tweeted from Sanofi:

1/2 IMPORTANT CLARIFICATION: @SanofiUS voluntary recall includes ALL Auvi-Q® (epinephrine injection, USP) devices currently in market.

— Sanofi US (@SanofiUS) October 28, 2015

And regarding the phones:

We are actively working to address phone line situation. You can continue to visit https://t.co/V6gVKtDo7B for info. Will update ASAP.

— Sanofi US (@SanofiUS) October 29, 2015

Stay Safe!

One Year Down

As of Sunday, James will have been seeing Dr. Li for a year. I thought I would want to celebrate, but to be honest, it seems routine. My guess would be that 1) he hasn't had any follow up blood work (he wants to wait until after Halloween for a draw) and 2) we are likely, at best, a third through treatment. It is hard to get excited at this point.

What I've Learned from One Year

Things will go wrong - Don't Panic

Missing Doses

There will be times when you miss doses, from forgetting, running out, or schedule issues. Missing a dose here or there is not worth stress. Do your best to be as consistent as possible, and accept that life happens and sometimes your schedule is thrown off.

Reactions

James has had reactions this year and hives and digestive problems however, he's had a lot fewer than ever. He has always had reactions and hives and digestive problems. Because the herbs are new to you, there will be a temptation to blame every problem on the herbs. It is possible that the herbs cause a problem. And, we have been handling hives, reactions, and digestive problems. You can continue to handle what comes using your own common sense. This doesn't mean to never consult your doctors. But, don't give up your own competency because you are doing something new.

Carry a Towel

When traveling, bring your own towels – the cream stains everything. Using your own towels will save you from embarrassment. If you are using Cream IIIb or IVB, green towels are best.

Please be thinking of us in the next couple weeks as we move forward with James's first year tests.

Allergy Friendly Copycat Candy Bars

Or, how I came to make two of my least favorite candies

When I was a child, I loved Butterfingers, one of my absolute favorites. I must have overindulged (a King sized bar was to blame I believe) and I had a nightmare. I ate a Butterfinger and ended up blowing an oil bubble as a result. It's pretty tame as nightmares go, but I was done with butterfingers. 

As an adult, I would have an occasional snack-sized bar, but I never regained my love. However, for the past couple years, I have been seeing easy homemade Butterfinger recipes and finally decided to give it a try.

Peanut Free Butterfingers

Free of: peanuts, tree nuts, wheat, fish, shellfish, milk       

Contains: Soy and Egg

*The soy means that James will not be able to eat them. It is in the form of soy protein in the candy corn. Luckily, I caught this before offering a taste.

Ingredients:

2 cups candy corn

2 cups Sunbutter

Chocolate coating (I used Vermont Nut Free dark chocolate melts)

Sprinkles (I used Target Dollar Spot sprinkles)

Directions

1. Melt the candy corn in the microwave in 30 second intervals until smooth.

2. Add the sunbutter and stir. This will not be easy and I recommend a mixer.

3. Press into an 8 x 8 or 9 x 9 pan which has parchment paper in it.

4. Put in the freezer for at least 30 min.

5. Cut the Butterfingers into pieces.

6. Using the directions here, melt your chocolate for dipping.

7. Cover with chocolate and quickly add the sprinkles on top.

Note:  Keep in mind that the smaller you cut the butterfingers, the more dipping you will have to do. This step may have gotten old for me.

And Mounds

I have never liked Mounds, not even as a child. They were only good for trading candy as far as I was concerned. However, I was not paying attention to our Amazon Subscribe and Save subscriptions and currently am buried in coconut. This was an attempt to use it up.

Free of: peanuts, tree nuts (except coconut), wheat fish, shellfish, and soy (yay!)

Contains: Egg and dairy (can be adapted to be dairy free)

Ingredients:

1 1/3 cup coconut flakes

2/3 c sugar

1/4 c cornstarch

1/2 c heavy cream

1/2 c coconut milk (in the carton not can)

2 egg yolks

2 T butter

Dipping chocolate and sprinkles

Note: To make dairy free, replace the 1/2 cup heavy cream and 1/2 c coconut milk with 1 cup full fat coconut milk from the can. Also replace the 2 T butter with coconut oil.

Directions:

1. Put the coconut milk and sugar in a saucepan.

2. heat over low heat until the sugar is dissolved.

3. Add the heavy cream, cornstarch, and butter and stir until combined.

4. Add about 1/3 c of the hot liquid to the egg yolks, stirring continuously. This will help to keep the egg yolks from scrambling.

4. While stirring continuously, add the egg yolk mixture to the pan.

5. Add the coconut flakes to the pan and stir until the mixture thickens.

6. Allow to cool in the refrigerator. Then place in the food processor and pulse until you have a smooth mixture. This step might not be necessary depending on the thickness of your coconut flakes.

7. Roll into balls (or flat ovals to copy Mounds more exactly).

8. Again, melt the dipping chocolate and use to cover each one. Add the sprinkles while the chocolate is still wet.

 

Making Progress

The Good News

James is still free of hives. If he continues hive-free this month, Dr. Li will have us begin to lessen his antihistamine dosage.

We have now "graduated" to every other month phone consults. My excitement is not at less contact with Dr. Li, but at the knowledge that she feels James has made enough progress to need less contact.

Dr. Li has switched from Mei Huang 4 to Mei Huang 5. James has used varying doses of Mei Huang 4 (and 3). At his highest dose, he was taking 20 pills two times a day. With Mei Huang 5, his ultimate dose will be only five pills two times a day. Currently, he is taking three because he felt nauseous with the higher dose. This has happened with his pills before and as he becomes accustomed, he is able to take more. So, while the dosage will increase slightly, few pills has meant a lower cost. We have gone from $1200 a month to $900 a month.

The Bad News

James had a minor reaction this week. I am not sure to what. He complained of throat itchiness and knew it was a reaction. It resolved with Benadryl.

All he had had was chicken and OJ. At first I thought perhaps his OAS now included oranges (although juices usually are pasteurized).  The pollen family his other OAS foods fall under is grass and orange is commonly listed in the cross reactivity lists. However, he has since had the same juice with no problems.

So, I turn to the chicken, which was a Costco rotisserie chicken. We picked it up on the way home from a museum and not from our normal Costco. It leads me to wonder if this Costco was not careful in preparing it, leading to cross contact with nuts from their bakery department. If this is the case, it was a very minor reaction and shows a lot of improvement from his previous cross contact reactions. And I will be more careful in the future questioning the stores before buying a rotisserie chicken.

Kindness of Strangers

We have been the recipients of many kind deeds from strangers this year - someone bought our lunch at In and Out, an online friend bought James an art class, people have willingly put away their peanut butter sandwiches when standing in line - and then, another person from a Facebook group gave us tickets to Disneyland's Halloween Party. I will admit to being completely overwhelmed by this generosity.

Our Night, Allergy Wise

Trick or Treating

As per an email from Disneyland Special Diets, I went to Town Hall to ask about trick or treating for those with allergies. James was not interested in trick or treating much - there was so much to do non-food related - but I still wanted to get the information so I could relay it. I was told that in previous years, information on the candy was kept at Town Hall, but now you should ask at each Trick or treat station. The cast members there should get you something from below their stand. 

We only went to one area with no line for trick or treating. The cast members there really knew nothing about allergies and dug through the candy to get what we told them was safe. There were four stops in this area and by the third, James was asking for carrot sticks and potato chips (the alternative snack) to avoid the hassle. It was not at all a big deal for him, but I can see that a younger kid might be more disappointed. It would be nice if they trained the people handing out candy as well as the chefs or had allergy friendly stations (maybe with non-food treats).

There were teal pumpkins at some of the stations, but these were only for decoration and had nothing to do with the Teal Pumpkin Project.

Dinner

James wanted pizza, so we headed to Pizza Port. The chef there informed us that they could not guarantee "that nut particles wouldn't end up in his pizza." She directed us to Tomorrowland Terrace, where they had no tree nuts or peanuts in the kitchen. The chef there was thorough, going over each ingredient several times. For instance, there was soy in the regular hamburger bun, but not the gluten-free one. The fries were cooked in soybean oil, but in their own fryer. We felt very comfortable with the care given to his order.

Non-Food Celebration

If there is a place where the food really doesn't matter, then this was it. We didn't stop except to eat dinner, and then we watched the Monsters U Dance Party. From the time we arrived until leaving, we rode every ride on our wishlist. The lines were virtually non-existent during the party. We watched the parade and fireworks.

Taking the focus off of food and onto fun is a good idea for everyone, not only those that are food allergic.

What plans do you have for Halloween that are not focused on food?

 

Teal Pumpkin Project

James's first reaction was the day before Halloween, three years ago. On Halloween night, with no diagnosis (although we were pretty sure it was the nuts he had been eating), I sent him trick or treating with his friends, no adults, his new epi-pens in his candy bag, with strict instructions, "Do not eat anything."

That rule holds today. We buy him our own candy and switch out when he gets home.

Even at 13, he still loves everything about Halloween: dressing up, being out on the streets at night with his friends, looking at the decorations.

The Teal Pumpkin Project

The Teal Pumpkin Project was started last year in an effort to raise awareness for food allergies. I don't do this for James, because he, honestly, is perfectly happy with Halloween. I do this for awareness and for other kids with food allergies or other medical conditions. At a minimum, if you print the sign and make non-food (not allergy safe, because the requirements for that vary widely) treats available, you will have participated. 

We are terrible candidates to participate. We live in an area where no one trick or treats (too rural). But, I still participate in the easiest possible way. I bring my teal pumpkin, my sign, and my non-food treats to our friend's house, where James will be trick or treating. 

For treats, I've gotten glow in the dark bracelets and I will get mini-comic books from the comic book store in October, when they are available.

I hope you will consider participating. It's not about not offering candy (my friend will take care of that on her end) but about offering options.

The TEAL PUMPKIN PROJECT and the Teal Pumpkin Image are trademarks of Food Allergy Research & Education (FARE).

Compliance

I would recommend taking 30 pills per day for 6 months as prescribed and see how that works before saying someone was slacking off #AAAAI15

— Nathan Hare M.D. (@AllergyTalk) February 23, 2015

One of my favorite tweets that came out of the American Academy of Allergy, Asthma, and Immunology conference this year. It arose as a reaction to an abstract  with a negative result. That is, the placebo group improved more than the treatment group. People often don't publish their results when they are negative, so this took a certain amount of courage (and is how science should proceed). The conclusion form the study is: "FAHF-2 is a safe herbal medication for food allergic individuals and shows favorable in vitro immunomodulatory effects; however, efficacy for improving tolerance to food allergens is not demonstrated at the dose and duration used." Emphasis is mine.

A theme in "curing" food allergies is that researchers are skilled at curing mice. It's the (murine to human) jump that can be a hurdle. But why?

Mice are controllable

Everyday, the mice in these studies all eat the same food. They don't go out with friends and get sick. They never miss a dose. Their stress level is controlled. As is their exposures allergens, both food and environmental. But, we are dosing a person with all the unpredictability that implies.

James's Record

As a person goes, James is compliant. He hardly ever misses a dose. He complains vehemently about the cream, but still applies it twice a day. But, other factors still come into play.

Stress

James is a perfectionist and puts himself under a vast amount of stress. In theory, I could lower his stress exposure, but the cost would be his maturing as a person.

Diet

Almost all of our meals are local and organic, but James loves snacks and pretty much snacks as a normal teenager (chips, candy, etc). 

Life

We have one. There are times when pills get forgotten, when he gets home late and puts on his cream without a shower, or has to be somewhere early and misses his bath.

Keeping up enthusiasm

Reviewing his progress

One of the benefits of going to NYC this summer was reviewing his improvements since he has started treatment. We were moving day to day and not taking time to reflect.

Not having hives anymore has also been a huge boost. He has a daily reminder, physically, that the treatment is working.

Sharing others progress

When people share their results in the CHA FB group, I share with him. I did this prior to him starting treatment as well. His own blood work won't be for another month, so hearing about others improving boosts his morale.

Not making a big deal

At fist, it seemed huge, insurmountable really as the number of pills he was taking kept going up. But now, it is routine. I tell him if he's had a change in protocol, but don't focus on it being hard or too much. It just is.

Whatever your treatment, have you had compliance issues? And how did (or do you) deal with them?