Sanofi US Recalls All Auvi-Q Epinephrine Injection

Use of sodium-glucose cotransporter-2 inhibitor (SGLT2) drugs should continue in patients with diabetes, in line with current recommendations, conclude the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE), in response to recent concerns from regulators about their safety.

The conclusion came after a 2-day conference in which experts from the United States and Europe reviewed available scientific data related to the possible relationship between SGLT2 inhibitors and diabetic ketoacidosis (DKA).

"The wealth of scientific and clinical data presented at this symposium has been ideal to enhance our understanding of the relationship between SGLT2 inhibitors and DKA," Robert Henry, MD, program chair and chief, section of diabetes, endocrinology and metabolism and the Center for Metabolic Research at the San Diego VA Medical Center, said in an AACE statement.

Sanofi US is voluntarily recalling all of its epinephrine injection (Auvi-Q) on the market because patients taking it for life-threatening anaphylaxis may receive an inaccurate and inadequate dose, the US Food and Drug Administration (FDA) announced today.

The company has received 26 unconfirmed reports of suspected device malfunction from patients in the United States and Canada as of October 26. No one died as a result, but patients continued to experience symptoms of underlying hypersensitivity reaction, the FDA said in a news release.

The agency said that patients using Auvi-Q should ask their physician to prescribe an alternate epinephrine autoinjector. If patients experience anaphylaxis, they should only use Auvi-Q if no other epinephrine autoinjector is available, and then seek emergency medical care.

Auvi-Q is distributed in packs that contain two active injectors, along with a training injector. There are roughly 490,000 packs of Auvi-Q on the market, all of them subject to the recall, Paul Chew, MD, Sanofi's global chief medical officer, told Medscape Medical News. Some packs contain epinephrine injection at 0.15 mg strength, and others at 0.3 mg strength.

The recall includes Auvi-Q packs in lots numbered 2299596 through 3037230, which expire March 2016 through December 2016.

References
SOURCE:

Sanofi US Recalls All Auvi-Q Epinephrine Injection.Medscape. Oct 29, 2015.

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