What is the potential or theoretical risk if the recalled product is administered to patients?
The manufacturing issues identified by Sanofi US are not related to the drug epinephrine. However, the products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug. 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.
Sanofi US has said this is a voluntary recall, but did the FDA advise Sanofi US to recall Auvi-Q?
Sanofi US discovered these issues as part of the routine manufacturer quality review and reported the findings to U.S. FDA. As a precautionary measure and in cooperation with the FDA, Sanofi US is voluntarily recalling ALL Auvi-Q on the market through October 28, 2015. This includes both the 0.15 mg and 0.3 mg strengths in lot numbers 2081278 through 3037230.
What should U.S. consumers do if they have Auvi-Q from the affected lots (2081278 through 3037230)?
First, they should immediately contact their healthcare providers for prescriptions for alternate epinephrine auto-injectors. Then people with an affected Auvi-Q device are being asked to go online anytime or call 1-877-319-8963 or 1-866-726-6340 8 a.m. – 8 p.m. ET, Monday through Friday for information about how to return their affected Auvi-Q devices.
For additional information on the return and reimbursement process, including online request form click here.
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 out of pocket costs (the price you pay at the pharmacy) incurred to replace their unexpired Auvi-Q devices with a replacement epinephrine auto-injector. In addition, if you purchased Auvi-Q devices at a cost that exceeds the cost of your replacement devices, Sanofi will compensate you for the difference, with proof of original and replacement product purchases.
Have you alerted healthcare professionals?
Yes, Sanofi US has actively been in contact with healthcare professionals.
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.
Important Safety Information
Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart related (cardiac) symptoms.
If you take certain medicines, you may develop serious life-threatening side effects from epinephrine. Be sure to tell your doctor all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson's disease, diabetes, high blood pressure, and heart disease.
The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects go away quickly, especially if you rest.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information and Patient Information.