Eli Lilly issued a voluntary recall of a single lot of glucagon emergency kits used to treat severe hypoglycemia in diabetics after a patient reported a loss of drug potency and seizures.
Lilly issued the recall after a patient reported that the vial of glucagon in the kit was in liquid form instead of powder form, the company said. An internal investigation by Eli Lilly indicated the problem could be related to the manufacturing process. The production site was not disclosed in the company’s press release.
The kits, which contain 1 mg of freeze-dried (lyophilized) product in a 3 ml vial and a pre-filled diluent syringe, are used to treat severe hypoglycemia in pediatric and adult patients with diabetes mellitus.
“Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated,” the company said. “Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.”
The lot was identified as D239382D.
Meanwhile, as Lilly deals with the recall and the potential production issue, the company is facing new competition from Xeris Pharmaceuticals.
In August, the FDA approved Xeris Pharmaceutical’s Gvoke Kit for the treatment of severe hypoglycemia, opening up a new front for the Chicago-based company to chip away at both Lilly and Novo Nordisk’s market share for diabetes treatments. Prior to the approval, Xeris’ Gvoke offerings accounted for $8.8 million in second-quarter sales. The company has said its share of the retail glucagon market is at about 16%, with Gvoke prescriptions topping 21,000 for the first time.
With the recent regulatory approval, Xeris can now offer the Gvoke Kit to patients who want to draw up their own doses of glucagon with a vial and syringe instead of using autoinjectors and prefilled syringes it already sells.