As anyone with an interest in reading this article already must know, all Allerject and Auvi-Q brand epinephrine auto-injectors distributed in Canada and the United States were recalled this week. This is a voluntary recall, not one mandated by the FDA or by Health Canada. I have never seen a recall that related to every item ever sold anywhere; in fact, every product recall I have ever seen has been limited to certain lot numbers. I was so surprised by this expansive recall that it caused me to come out of seclusion to look into things and to write this article.
When I looked at the press release and news articles regarding the recall carefully, I was even more confused. There were only 26 adverse incident reports, of which 9 were Canada based, none of them has been confirmed, and none of them reported any adverse effects on the patient. I learned that unconfirmed means that the device was not returned to Sanofi for investigation or that in returned ones the device malfuction could not be seen and/or that medical reports had not been reviewed. As Dr. Chew of Sanofi states in Allergic Living’s recent article:
“We have no evidence to date of the device malfunction. Of the  cases reported of device malfunctions – of all the ones that were sent back [to the company] – we were not actually able to see the device malfunction. So the basis of the recall is for the potential of an inaccurate dosage. Also, that’s 26 cases reported out of 2.8 million units in North America since the launch of Auvi-Q in the U.S. and Allerject in Canada in January 2013. So it’s a low risk, we believe, and that’s why this is a precautionary recall.” [emphasis added]
Despite the small number of reports, I was advised by Sanofi Canada that their pharmacovigilance team flagged the complaints internally, and the rest is recent history.
Sanofi’s press release states that an estimated 2,784,000 units were distributed in North America and 26 have unconfirmed malfunction reports, leading to an unconfirmed failure rate of 0.000009%. Stated differently, for each one million users, only 9 users reported any suspected device malfunctions.
When you carve out the figures for Canada only from Sanofi’s press release, of 492,000 units distributed in Canada, there were 9 suspected device malfunctions reported. This leads to a rate of 18 unconfirmed failures for every million Canadian users. I learned from Sanofi Canada that all the Allerject injectors for Canada and the Auvi-Q injectors for the USA are made in the same location by a third party company called Medivative Technologies in Indianapolis, Indiana. They are not made in a separate location for each country.
Please keep in mind that Sanofi states in its press report that patients have described symptoms of the underlying hypersensitivity [allergic] reaction and that no fatal outcomes have been reported among these cases. To me, this risk seems minimal given the numbers and the outcomes for such a massive and dramatic voluntary response.
I then learned from a contact in the industry that companies like Sanofi perform a risk analysis when complaints are received. If say the product is a sleeping pill and the adverse event likelihood is that the person doesn’t fall asleep, this would be lower risk. What likely tipped the risk analysis based on this small number of unconfirmed reports regarding accuracy of epinephrine dosage into a massive recall is that the risk of inadequate epinephrine dosage during anaphylaxis is death.
If you’re curious (I was), the patent information for the Auvi-Q device is here and flipping through the figures is absolutely fascinating. . The inventors are Eric S. Edwards, Evan T. Edwards, Mark J. Licata, Paul F. Meyers, David A. Weinzierl. The EpiPen patent is here, and you’ll see that it was invented by John Glyndwr Wilmot, Rajesh B. Shukla, Clarence Michael Mesa, Megha V. Mahadevan.
It’s interesting to note that both device patents advise that a portion of the medicament flows out of the device from the cartridge, and the EpiPen patent further explains that a small or residual amount remains specifically in the needle and neck of the device. I am particularly interested in this information, since the Auvi-Q recall relates to alleged improper dosing, and I was looking to see how much medication is supposed to be left behind in the cartridge and how much extra medication one could receive if the device malfunctions, and now I know that would be a minimal amount.
The Allerject and Auvi-Q injectors that are returned to pharmacies will be sent back to the distributor and on to Sanofi for testing. This will allow them to stop use of the injectors to avoid patient harm via any adverse events, to discover if there is indeed an issue, and to try to bracket the issue or segregate it into lots of injectors produced. This will allow them to dive down and discover (if any issue is confirmed), whether it was due to a quality issue such as a change in the plastic used for that lot, a change made to the speed of dosage delivery, or perhaps an overall design flaw. Sanofi will then respond to the FDA and Health Canada within 15 days to get validation and to advise how they will fix any issue. Please keep in mind that this product previously endured quality testing to be released. I strongly suspect that it will pass this investigation.
I am receiving reports that users are panicked and are flocking to pharmacies to replace their Auvi-Q or Allerject with the EpiPen replacement that Sanofi is providing to its customers. My pharmacy called me the day following the recall to advise that they are already out of stock of EpiPens and will not have sufficient supply for two weeks. I was in no hurry to get there, as I suspected that patients were simply jumping from the frying pan to the fire.
Specifically, to gain perspective on this matter, I looked at EpiPen failure statistics/malfunction reports. During the two years that Allerject has been on the market, there have been 34 adverse reaction reports regarding the EpiPen in Canada. That same database shows 10 reports during that period regarding Allerject. While many more EpiPens than Allerjects have been distributed in Canada, I hope you see what I mean when I say that switching back to EpiPen is like jumping from the frying pan to the fire: EpiPen had three times the number of failure reports during the same period.
You may not be surprised to learn that in my humble opinion, 99.99% of the risk of inaccurate epinephrine dosage is user failure. For example, patients are using a Junior 0.15 dose of epinephrine when their children weigh enough for a regular dose. If you ask your doctor or allergist to do an exact calculation based upon the ideal dose of 0.01 mg epinephrine per kilogram, he or she can help you determine if the Junior pen has adequate epinephrine for your child. In addition, patients usually don’t carry two pens, so they don’t have a second dose of epinephrine immediately available for use within a few minutes if the initial dose doesn’t provide significant relief. Many patients don’t know that you should administer a second dose in that situation. When I read story after story of anaphylaxis fatalities, I see that they’re not following the World Allergy Organization Guidelines for the Assessment and Management of Anaphylaxis and injecting too late, not 1 to 5 minutes from the start of the reaction, or as we learned and agreed following Natalie Giorgi’s death, immediately upon known ingestion of one’s allergen. They’re also failing to follow the injection by immediately lying down with feet above heart level as lying down keeps blood in the core, returns blood to the heart for it to pump, and helps epinephrine circulate, and they’re failing to call an ambulance for medically supervised transportation to the hospital. Instead, many are delaying the trip to the hospital and going if at all by car. Finally and sometimes tragically, they’re also neglecting to train themselves and their allergic children in anaphylaxis first aid, though online training exists at an affordable price.
I still think the Allerject/Auvi-Q is an excellent product. My son always wore two EpiPens in the EpiPen belt I used to sell, which is extremely discreet and comfortable. When I commented to him last summer that it’s excellent he still wears his belt at age 13, he said he’d love not to and he asked to switch to an Allerject because it would fit in his pocket, and I agreed and bought him an Allerject which he slipped in his back pocket. He was amazed at how much more comfortable he felt without a belt and remarked that this is how it feels to go outside without an EpiPen belt and to sit in a car without an EpiPen belt under his seat belt.
Interestingly, on the first day of the recall, I received several email messages and a phone call seeking my belts, since people were picking up replacement EpiPens and needed a way to carry them. For the record, I no longer sell the belts, and they’re not available anywhere else. I will not force Jacob to go back to wearing a belt to carry epinephrine, and at seven inches long, EpiPens simply cannot be carried in a pocket. One should never be separated from one’s injectors, but the EpiPen design encourages one to carry it in a backpack or purse causing separation from one’s injector. I fell in love with Allerject not for these reasons but for technical reasons, specifically the speed of the injection and the fact that the needle enters the body at exactly 90 degrees, causing minimal tissue damage. Reports of extensive tissue damage with EpiPen use were very recently documented in this Doctor led study from last month noting that there is room for injury during the 10 second long injection because a panicking child (or a parent with shaking hands) may move during the process. The study’s lead author, Dr Julie Brown, recommends patients consider using Allerject or Auvi-Q because the device’s needle is short, retractable, and stays in the body for just 2 seconds. Jacob fell in love with Allerject for personal reasons due to comfort of carrying. Oh, how we do not wish to go back to EpiPen!
We’re hanging on to our Allerject. There are no replacement EpiPens in stock in any event, but I trust the Allerject device as much today as I did before the recall. Honestly, my intention is not to trade it in at all. I am assured by Sanofi Canada that they are committed to finding out what the issue is (if any), finding the Solution (if needed), and bringing the product back to Market in Canada and in the USA.
On the day of the recall, I visited Allerject’s Twitter page, and the girl in advertisement looked to me like she was waving goodbye. I hope that within a few weeks, all concerns will be satisfied and she’ll look to be waving hello to us as Allerject and Auvi-Q devices will be back on the shelves again. Until soon, stay safe and well informed, everyone.
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