The unprecedented recall of all Auvi-Q and Allerject epinephrine auto-injectors this week by Sanofi US and Sanofi Canada has led to many questions for those who depend on the devices as life-saving medication in case of a severe allergic reaction.
Allergic Living interviewed Sanofi US’s Dr. Paul Chew on Oct. 30, 2015 to gain some insights. Dr. Chew is senior vice president, group chief medical officer, and head of the North America R&D hub for Sanofi.
Q. Can you tell us the events that led to this recall?
Dr. Chew: Our contract manufacturer in June discovered that there were product issues with specific lots during a quality inspection. That led to a [June 2015] recall and non-distribution of specific lots of Allerject in Canada.
This month we discovered an additional issue. Similarly, we are working to determine if the issue is limited to certain lots of Auvi-Q. So we made the decision, proactively, to have a voluntary, precautionary withdrawal, of all the Auvi-Qs and Allerjects.
Out of an abundance of caution, we have temporarily ceased manufacturing until we’ve identified the problem.
Q. What should a patient do if they have a reaction and have yet to replace the Auvi-Q or Allerject auto-injector?
Dr. Chew: The first thing patients should do is seek out an alternative auto-injector. In the event of a life-threatening allergic reaction, patients who do not have a replacement product should use their Auvi-Q or Allerject device – and then immediately call 911 and seek emergency medical help.
Q. With that earlier, limited Canadian recall, a defect with the needle was mentioned. Is that also an issue in this full recall?
Dr. Chew: We’re looking at the whole assembly [of the auto-injector]. We’re looking at the whole process.
Q. How many auto-injectors is Sanofi pulling from the market at this time?
Dr. Chew: It’s about 490,000 units in Canada. In the U.S., it’s about 500,000 packs. The packs are different. In Canada, it’s one unit per pack; in the U.S. there are two in a pack, plus a trainer device.
Q. What’s the process for Americans who own Auvi-Qs to get reimbursement for their recalled devices?
Dr. Chew: People should return all of the Auvi-Q devices, and Sanofi US will reimburse patients for the out-of-pocket costs required to replace the unexpired Auvi-Q devices. We will be reimbursing people for the full cost of the replacement epinephrine auto-injectors.
In addition, if someone purchased Auvi-Q devices at a cost that exceeds the cost of replacement devices, Sanofi will compensate for the difference, with proof of original and replacement product purchases.
Q. In announcing the recall, Sanofi cited possible issues with how much medicine its auto-injectors were delivering. Have you confirmed if ‘dose delivery’ is a problem?
Dr. Chew: 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.
Q. What were the symptoms seen in the 26 reports of suspected malfunctioning auto-injectors?
Dr. Chew: The most frequent symptoms that occurred in these 26 reports were those of serious allergic reactions, and hypersensitivity reactions, that were typical of an allergic reaction.
Q. Did the device reports lead Sanofi to conduct quality inspections?
Dr. Chew: We regularly quality control our products to ensure quality. These 26 reports are the cumulative experience – so the two are parallel. Of those 26, nine were reported in Canada.
Q. People who adopted the Auvi-Q or Allerject for their emergency medication needs are asking about the future of the device. Can you comment on that?
Dr. Chew: We’re very pleased that the Auvi-Q and Allerject devices have had such a positive response among patients. That’s why we took this action.
In terms of next steps, the first thing that we need to do is fully understand what the issue behind this potential inaccurate dosage delivery is. Then I think we’ll be able to comment better.
We are conducting really detailed investigations as we’re speaking.
For further information and details on the Auvi-Q recall, including reimbursement information, visit Auvi-Q.com.
For further information and details on Allerject recall in Canada, visit Allerject’s website.