FDA approves first treatment for severe hypoglycemia that can be administered without an injection

FDA on Wednesday approved glucagon nasal powder (Baqsimi—Eli Lilly). This is the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. The product is approved to treat severe hypoglycemia in patients with diabetes aged 4 years and older.

FDA on Wednesday approved glucagon nasal powder (Baqsimi—Eli Lilly). This is the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. The product is approved to treat severe hypoglycemia in patients with diabetes aged 4 years and older. "People who are living with diabetes are at risk of their blood sugar levels falling below the normal range," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research. She noted, "There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process. This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure." The glucagon nasal powder will come in a single-use dispenser that can be given to someone suffering from a severe hypoglycemic episode. The product increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream. The glucagon nasal powder should not be taken by people with pheochromocytoma or those with insulinoma. Additionally, the product should not be taken by individuals with a known hypersensitivity to glucagon or the inactive ingredients in it. The product carries a warning that it should be used with caution by people who have been fasting for long periods, have adrenal insufficiency, or have chronic hypoglycemia. The most common adverse reactions associated with the glucagon nasal powder are nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness.