Allerject epinephrine auto-injectors recalled by drugmaker Sanofi

Drug company Sanofi is recalling hundreds of thousands of epinephrine auto-injectors in North America used to treat severe allergic reactions because they may not deliver the correct amount of the life-saving drug.

The company's Canadian subsidiary, Sanofi-aventis Canada, said the recall affects all of its epinephrine injectors, sold in Canada under the brand name Allerject.

In the U.S., the device is sold under the brand name Auvi-Q.

"The products have been found to potentially have inaccurate dosage delivery," Sanofi-aventis Canada said in a statement on Wednesday. 

• ER visits for anaphylactic reactions increase
• Epinephrine allergy auto-injectors recalled

"If a patient who is 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."

The statement said that as of Monday, Sanofi's U.S. and Canadian subsidiaries have received "26 reports of suspected device malfunctions from an estimated 2,784,000 units distributed in North America."

Nine of those suspected malfunctions were reported in Canada, out of an estimated 492,000 units distributed in the country since Allerject went on sale in 2013, the company said. 

It said none of these device malfunction reports have been confirmed, but that patients had described symptoms of the underlying hypersensitivity reaction.

"No fatal outcomes have been reported among these cases," Sanofi-aventis said.

EpiPen competitor

​Sanofi's product competes with Mylan's EpiPen, which is a staple of first-aid care. Both products are used to treat anaphylactic allergic reactions caused by insect bites and stings, foods, medicines or other substances.

"As this is a life-saving device, it is important that consumers understand not only to return the recalled device and seek a replacement epinephrine auto-injector," a company spokeswoman said in an email.

"In the absence of availability of an alternate epinephrine auto-injector, patients are instructed to retain their Allerject device until an alternate auto-injector is available."

Sanofi said Thursday it's contacted other makers of epinephrine auto-injectors to let them know of an expected increase in demand for their products.

Health Canada is instructing people who have an Allerject device to get in touch with a pharmacy to arrange to obtain a replacement.

"In the event a life-threatening allergic reaction (anaphylaxis) occurs before you can obtain a replacement auto-injector, use your Allerject device as directed by your health-care provider, and then seek emergency medical attention," Health Canada said in a statement on its website.

"In light of the need to manage supply, patients are being asked to initially limit the replacement of Allerject to one unit, unless otherwise instructed by their healthcare professional until such time that additional supply can be distributed," a spokeswoman for Health Canada said in an email. 

Halloween a high-priority time 

Dr. Elana Lavine is an allergist at Humber River Hospital's department of pediatrics in Toronto. 

"People are understandably scrambling to make sure that their kids and themselves are equipped," said Lavine. She anticipates there will be some supply and demand issues that will have to be worked out in the next few days to weeks.

"In my own experience, Halloween is a very high-priority time for kids with food allergies, particularly peanuts, tree nuts and milk," since many treats that are given out are not allergen-free. 

Lavine has been having conversations with families about putting safety plans in place.

"The timing of this, so close to Halloween, is definitely contributing to a little bit of anxiety on the parents' part," she said.

Both Allerject and EpiPen deliver identical doses of  epinephrine. Each contains a needle that injects the medication deeply into the muscle of thigh, which is considered the most efficient way, Lavine said.

The recalled device has a voice component to prompt someone with step-by-step instructions on how to use the device.

There are also cosmetic differences between the brands in terms of size and shape. 

Hospitals, retailers and consumers may have the recalled products. The company said a breakdown of distribution of the products in Canada is not available. 

In July, Health Canada publicized a smaller recall of two batches of the 0.15 milligram Allerject injectors intended for use in children. The regulator said a manufacturing defect that could render the device ineffective at delivering the medication in an emergency.

In its third-quarter global financial results released Thursday, Paris-based Sanofi said that the recall of its epinephrine injectors may end up wiping 100 million euros ($145 million) off its bottom line.

The company said the financial impact of recalling its Allerject and Auvi-Q devices in Canada and the U.S. is an initial estimate, and the final amount will be accounted for in the fourth quarter.