Severe hypoglycemia, though rare, can have devastating effects. It affects people with type 1 or type 2 diabetes using insulin or sulfonylureas. If someone loses consciousness or has a seizure due to dangerously low blood sugar, glucagon must be given immediately by someone nearby.
The FDA recently approved glucagon nasal powder as a second option for treating severe hypoglycemia. Clinical trials show it works as effectively as injectable glucagon to raise blood sugar levels.
This nasal powder provides a simple, effective tool for managing severe hypoglycemia. It is approved for use in patients aged four and older.
FDA APPROVAL, July 2019
The U.S. Food and Drug Administration today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection.
Severe hypoglycemia occurs when a patient’s blood sugar levels fall to a level where he or she becomes confused or unconscious or suffers from other symptoms that require assistance from another person to treat. Typically, severe hypoglycemia occurs in people with diabetes who are using insulin treatment.
- Injectable glucagon has been approved for use in the U.S. for several decades. The efficacy and safety of Baqsimi nasal powder glucagon to treat severe hypoglycemia was evaluated in two studies of 83 and 70 adults with diabetes, comparing a single dose of Baqsimi to a single dose of glucagon injection in causing a blood sugar response to insulin-induced hypoglycemia. Baqsimi adequately increased blood sugar levels. In a pediatric study of 48 patients over the age of four with type 1 diabetes, similar results were observed.
- Baqsimi should not be taken by patients with pheochromocytoma, a rare tumor of adrenal gland tissue, or by patients who have insulinoma, a tumor of the pancreas.
- Baqsimi is approved to treat severe hypoglycemia in patients with diabetes ages four and older.