As Sanofi recalls its Auvi-Q epinephrine injection for the treatment of severe allergic reactions – after the company found the products may have been affected by inaccurate dosages – the French firm says the impact could results in a $109 million financial loss.
Sanofi received 26 reports of ‘suspected device malfunctions’ – 17 in the US and nine in Canada. It said that it was recalling 492,000 packs, most of which contain two devices, after the products were found to have potentially delivery inaccurate doses. The voluntary recall involves all Allerject (epinephrine injection) marketed in the US and Canada. This is thought to total around half a million devices, including both the 0.15 mg/0.15 mL and 0.3 mg/0.3 mL strengths for hospitals, retailers and consumers.
The recall came after Sanofi received more than two dozen reports of patients who had an adverse reaction after using their injector. Patients have described symptoms of the underlying hypersensitivity reaction. However, no fatal outcomes have been reported among these cases.
This recall is being conducted with the oversight of the FDA, who granted approval in 2012. There are thought to be approximately 200,000 people in the United States who use the Auvi-Q injector.
The estimated loss comes as Sanofi warns revenue in its diabetes division driven are expected to fall in 2018 due to loss of patent protection and the resulting decline in sales of Lantus. Sanofi now projects global diabetes sales over the period of 2015-2018 to decline at an average annual rate of between 4% and 8%.
However, Sanofi said sales in its Genzyme division grew by 32% during the third quarter, driven mostly by sales of multiple sclerosis products, as well as an increase of sales in emerging markets.