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.

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.

Too, too many

Can anyone explain what it is about this time of year? Nearly a year ago, I was lamenting that I wanted to crawl back under a food allergy rock and not pay attention to all of the deaths that were happening, one on top of the other. Now, here we are in mid-October and we've had three in the span of the last month. The summer months were blissfully sparse in news of food allergy deaths, and yet here we are, a few months into the school year and prepping for fall/winter holidays, and the deaths are piling up. And all of them teenagers. Can anyone speculate as to WHY?

We know teenagers are the highest-risk group, but even so, I'm beginning to dread this time of year. Is it because the beginning of the school year is a time when people to want to fit in? Impress their friends and new classmates, and admitting to (or properly preparing for) food allergies seems like a waste of time or, worse yet, uncool?

Or is it that with all the newness of a new school year, sometimes our safety precautions get forgotten? Even returning to the same school is new--new grade, new locker, new teachers, new clothes and backpack, new supplies, new classmates, newer and harder classes. Is this just too much for the teenage mind to manage?

Or could it be that with school celebrations and upcoming holidays, food is more prevalent and part of our celebrations, and when we're surrounded by so much bounty it's easier to slip up?

I don't know if any of my speculations are part of the big picture, but I do know that this seems to be a dangerous time. Please take care of your loved ones this year. Our kids may hate it when we constantly remind them of the same thing, over and over, but keep reminding them to bring their epinephrine--to school and when going out with friends. Make sure the school office has a backup, even if your teenager is (hopefully) self-carrying. Set alarms, download apps, post notes by the door, wait by the door with epi in-hand.... but do whatever it takes to make sure your kids remain prepared. And if YOU have allergies, don't leave home without it either.

Epi will save a life. Let's all take care of each other this holiday season.



Morgan Elizabeth Crutchfield
October 5, 2015
http://allergicliving.com/2015/10/09/north-carolina-teenager-dies-from-food-allergy-reaction/

Simon Katz
September 21, 2015
http://www.denverpost.com/news/ci_28864937/chatfield-high-student-dies-after-eating-smore-containing

Andrea Mariano
September 18, 2015
http://allergicliving.com/2015/09/19/first-year-college-student-dies-of-severe-allergic-reaction/

EpiPen4Schools

I recently came across this great program!

Logo used with permission

www.epipen4schools.com

Here's how it works:

The program offers four FREE EpiPen® or EpiPen Jr® Auto-Injectors to qualifying public and private kindergarten, elementary, middle and high schools in the U.S. Requirements to qualify for this offer include having a valid prescription. The products are available in the form of two EpiPen 2-Pak® cartons, two EpiPen Jr 2-Pak® cartons or one 2-Pak of each kind. Each EpiPen 2-Pak® contains two single auto-injectors, instructions for use and a EpiPen® Trainer, with no drug product or needle, to help patients become familiar with the administration technique.

I just had to read that twice.  FREE EpiPens for schools to keep on hand for anyone who needs one?  How awesome is that??!!  And it gets better:

In the event that the free supply is used to respond to an allergic emergency (anaphylactic event), qualifying schools are eligible to receive a replenishment order of EpiPen® or EpiPen Jr® Auto-Injectors prior to their annual eligibility date at no additional cost.

I shared this with Zax's school nurse right after I found out about it.  She sounded wary when I asked whether the school already had stock epinephrine, but got really excited when I told her about the program.  She told me that we have a few students who have been diagnosed with food allergies, but whose parents are unable to afford to keep epinephrine at school, so stock EpiPens would be a terrific way to keep them safe until paramedics can reach the school.

I also know that we have one student who has an allergic parent and he's never eaten his parent's allergen--but he's convinced he's allergic, too.  I can only imagine that he has no EpiPen since he's undiagnosed, so stock epinephrine would be a good safety net in case his suspicion is correct and he's accidentally exposed at school.  Other kids can have their first exposure to an allergen at school too, so there are plenty of reasons why having stock epinephrine on hand is safer and helpful!

The last I heard, our school nurse had passed this on to the district nurse, and they're in the process of qualifying.

I also shared this with Kal's preschool. I don't know whether a private preschool would be eligible (it doesn't mention preschools on the website) but I figured it was worth a shot. The Admin informed me they'd been considering stock epinephrine anyway!

Mylan is also extending their $0 copay program for EpiPens into 2015, so check that out if your copay is more than a few bucks!
https://www.epipen.com/copay-offer

And don't forget to check out our Peanut Allergy Slap Bracelets! We expect to have a few more allergens available in a few weeks!

I think it's great that Mylan Specialty wants to give back!  Be sure to share this with your child's school and with your social networks--undoubtedly you know more people touched by food allergies than you think, and they could all benefit from this!

The Flu

I had half of what I thought was a really great post written for you today, and then all my plans were thrown out the window.  Hubby and I had hoped to do some exciting stuff for our business too, but that also was thrown a curveball.  Instead of doing the things we'd hoped, we went to the ER instead.

Zax started coughing Sunday night, but not overwhelmingly so.  We figured he was getting a cold.  He said he felt okay Monday morning, but rapidly slid downhill.  A few hours after school was supposed to start, he not only said he didn't feel well, but complained of a headache too.

Now, Zax sometimes get headaches that we figure are migraines.  They haven't happened frequently enough to see a specialist, but migraines run in the family and they seem to fit the pattern.  During these headaches, he cries constantly unless he's asleep, and just totally shuts down.  Especially if we don't get him painkillers the moment he first complains.

So that's all we thought was happening, but Monday he just kept carrying on.  Finally, he'd been crying for so long, even an hour after painkillers (which should have taken effect), so I started digging for more.  That's when he revealed that it hurt to breathe.  I listened to his back, and definitely heard wheezing.

I gave Zax a dose of his brother's albuterol in the nebulizer, and it helped.  Shit, I thought.  I mean, good that it helped, but I really felt down at that moment. I showed signs of asthma before my 2nd birthday, Kal started showing signs of asthma right after he turned 1, so I'd been hoping that Zax had dodged that particular bullet by making it to age 6 with no signs.  Feeling depressed, I made mental plans to call our allergist's office in the morning while finally feeding Zax and then getting the boys ready for bed.

Two and a half hours after Zax's neb, as I was laying beside him in bed, I realized that he was wheezing again.  He was also taking short breaths, and his breathing was making it impossible for him to settle down to sleep.  It was too soon for another neb, so I briefly consulted my husband and took him to the ER.  Not a moment too soon, either, because his breathing got worse in the car and he started his incessant screaming again.  (Among other things, I felt bad about how long he had probably been in distress before I noticed.  He'd had a headache, but it was secondary :(

I didn't feel too horribly worried until we got to the ER and they raced him into a room after barely taking his vitals.  It's that bad?  Oh shit!  They gave him all sorts of meds, including magnesium-something in his drip, somewhere around 6-8 vials of albuterol, and even epinephrine.  But the thing that scared me the most was the speed at which they worked. *shudder*

They got him stabilized and then looked for what might have brought us in.  It definitely wasn't anaphylaxis, he'd barely eaten anything all day.  I'd been thinking enterovirus, but I was wrong.  Apparently, that's waning.

The culprit?  The flu.  "Influenza A."  And this, after his allergic reaction to his flu shot.  It didn't even protect him.  According to the hospital staff, something has mutated or deviated this year, so the flu shot isn't providing full immunity.  Brother.

After Zax's allergic reaction to the shot, the allergist had said that since his reaction wasn't systemic, they would probably still advise getting a flu shot next year, they would just spread it out more. They'd put it in his thigh rather than his arm, because it's a bigger muscle, and probably do a half dose in each leg.

I'll be honest.  I wasn't sure what I thought of that suggestion.  What if the next reaction was worse?  At least I had a year to decide what to do.  However, after seeing Zax hospitalized and struggling for breath from the flu, I will continue to get him a flu shot unless he starts having really serious reactions to the shot.  Hopefully next year the shot will hit the mark again, and I'd much rather deal with redness and itchiness for a day than spend part of three days in the hospital, watching my child's heart rate soar because of all the stimulants they've given him but still seeing that he has a long road to recovery.

I write this just before going to bed Tuesday night, listening to Zax breathe in the hospital bed.  His respiration is slow and easy now, without the aid of supplemental oxygen.  I'm thankful that he bounced back so fast.  This afternoon, I went from consoling him, to simply being with him, to doing my best to keep him out of trouble.  He took several unassisted walks and figured out the controls for the hospital bed (which occupied him for at least an hour.)

We'll be heading home in the morning, hoping that hubby and Kal don't get this (especially Kal, since his lungs are already compromised.)  As for me?  I laid in a bed and shared other close contact with my poor, sick child.  I started getting symptoms Tuesday.  Hopefully with early application of Tamiflu and aggressive treatment with albuterol and Flovent, mine will be mild (and not land me back in the hospital.)

Be wary of the flu this year!  Get lots of rest and wash your hands a lot.