October 29, 2015
By Alex Keown, BioSpace.com Breaking News Staff
Bridgewater, N.J. -- Sanofi US is recalling its Auvi-Q epinephrine injection for the treatment of severe allergic reactions, after the company determined the products may have inaccurate dosage delivery. The recall is expected to have a $109 million impact on revenue, the company announced Wednesday night.
The company is recalling about 490,000 packages of the devices, including the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers, Sanofi said. The recall includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. Sanofi said it initiated the recall after receiving 26 reports of suspected device malfunctions in the United States and Canada. None of the reports involved a death, the company said. Additionally, Sanofi said none of the malfunction reports have been confirmed. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA), Sanofi said in a statement. The injector was approved by federal regulators in 2012. There are approximately 200,000 people in the United States who use the Auvi-Q injector, CBS reported. Sanofi said it is notifying retailers and other customers about the recall and is arranging for return and reimbursement of all recalled products.
The recall may have a $109 million impact on the company’s bottom line, the Associated Press reported. The estimated loss comes as Sanofi warns revenue in its diabetes division driven in large part by declining sales of Lantus are expected to further decline through 2018 due to loss of patent protection on the drug. Sanofi now projects global diabetes sales over the period of 2015-2018 to decline at an average annualized rate of between four percent and eight percent at constant exchange rates, Sanofi said in a statement regarding third quarter earnings.
But, Sanofi said sales in its Genzyme division grew by 32 percent during the third quarter, driven mostly by sales of multiple sclerosis products, as well as an increase of sales in emerging markets.
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. Auvi-Q is packaged with two active devices and one trainer device. 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. Auvi-Q directly competes with Mylan’s Epipen. During the recall, Sanofi said in the event of an allergic emergency, patients should only use their Auvi-Q device if another epinephrine auto-injector is not available, and then call 911 or local medical emergency services. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program, Sanofi said.
Sanofi US is committed to patient safety and the quality of Auvi-Q, and will continue to work closely with customers and regulatory authorities to resolve this issue in a timely manner, the company said in a statement.
