We know that many of you have been frustrated (to say the least) reaching Sanofi regarding the firm’s recent recall of all Auvi-Q epinephrine auto-injectors.
We received notification from Karen Sutherland of Sanofi US Product Communications that the firm has added a hotline for inquiries.
The hotline can be reached Mon-Fri 8AM-8PM ET at:
Please note that Herr Foods has issued a voluntary recall of certain bags of its 1.875 oz. Sour Cream and Onion Potato Chip due to a packaging error that incorrectly states that the product is gluten free. This variety is not listed in the Safe Snack Guide or Allergence product screening service.
As you probably know, Sanofi has recalled ALL Auvi-Q and Allerject brand epinephrine auto-injectors from the US and Canadian markets. If you own these brands, it is imperative that you read the press release and replace them with alternatives.
There are two other brands of auto-injectors available in the US: EpiPen®/EpiPen Jr® by Mylan, and Adrenaclick® (also sold as a generic) by Amedra.
Though Sanofi has pledged to reimburse consumers for the switch to another brand, consumers will have to purchase new auto-injectors, then seek reimbursement from the company. Unfortunately, the cost of a single pair of auto-injectors can run into hundreds of dollars and will likely be a financial burden to many of our readers.
Following Sanofi US’s recall of all Auvi-Q auto-injectors sold in the US, Sanofi Canada has issued a recall of all Allerject auto-injectors sold in Canada. Allerject and Auvi-Q are Sanofi’s brand names for the same product sold in the US and Canada respectively.
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 email@example.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.
Sanofi US has issued a voluntary recall of all Auvi-Q epinephrine auto-injectors in the US, including both the 0.15mg and 0.3mg doses. They have been found to potentially deliver the wrong dosage.
the firm has received 26 reports of suspected device malfunctions in the US and Canada as of October 26, though none of these malfunctions have been confirmed by the company and no fatalities have been reported to date.
Two emerging therapies received the Food and Drug Administration’s (FDA) “Breakthrough” designation for the treatment of food allergy this year. We’ll take a look at what it means to be a breakthrough therapy, who is developing these them, how they work, and the (big) business drivers behind them.
The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in July 9, 2012. Section 902 of the legislation provides for a new fast track designation – Breakthrough Therapy. According to the FDA, a breakthrough therapy is a drug:
- intended for use alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
- preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
A drug given such a designation is provided expedited review by the FDA, though the sponsor must still demonstrate that it is effective and safe. The FDA assigns senior resources to work with the sponsor on a continual basis to speed up the entire process from clinical trials through approval.
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While parents of children diagnosed with food allergies battle to keep their kids safe, a new study shows that it is not only their children that are at risk for developing life-threatening anaphylaxis at school.
The study, to be presented at the American Academy of Pediatrics (AAP) National Conference & Exhibition in Washington DC this week, looked at schools that participated in the EPIPENS4SCHOOLS program during the 2013-14 school year. The program, sponsored by Mylan Specialty, provides stock epinephrine auto-injectors to 59,000 public and private, elementary, middle and high schools across the United States for use during anaphylactic emergencies.
Among the 6,019 schools responding to the survey, 919 anaphylactic events were reported with 22% of the cases occurring in individuals with no prior history of allergy. These children would not have had access to their own prescribed auto-injector.
Legislation that would provide for stock epinephrine in places of public accommodation has cleared committees and is now under consideration by the New Jersey Senate and General Assembly.
Entitled the Epinephrine Access and Emergency Treatment Act, the bill (designated S-2884 and A-4094) would allow individuals who have completed an approved training course to maintain and administer epinephrine auto-injectors for emergency use, and employers of those individuals to obtain stock epinephrine for use by them. The legislation also provides the necessary “Good Samaritan” provisions to shield all involved from liability when epinephrine is administered in good faith during an anaphylactic emergency.
Anaphylaxis is a serious, sometimes life-threatening allergic reaction to a food, medication or insect sting. Epinephrine is the only approved treatment for anaphylaxis and should be administered as soon as anaphylaxis is suspected.
We’re pleased to announce the inclusion of many new products with the addition of a new member to our Manufacturer Partnership.
Herr Foods manufactures an extensive line of savory snacks including potato chips, pretzels, popcorn and cheese curls. The family owned and operated company began 67 years ago in Lancaster, Pa., and now employs more than 1,500 people who make 340 delicious snack products that are available worldwide. Though a small number of Herr’s products were previously listed in the Safe Snack Guide, the company has joined us as a full-fledged partner and now many more of their products are listed both in the Guide and Allergence, our interactive allergen screening service. Click here to learn more about Herr’s and their products and click here to read the press release.
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