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.