FDA approves non-injectable treatment for hypoglycemia



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The US Food and Drug Administration (FDA) has approved the first glucagon treatment for the treatment of severe hypoglycemia in patients with type 1 diabetes, which can be administered directly into the nose rather than by injection.

Baqsimi Nasal Powder (Eli Lilly and Co., Indianapolis, Indiana) is supplied in a single-dose dispenser that eliminates the need to mix glucagon injection and allows immediate administration in severe hypoglycaemia. The drug increases blood sugar levels in the body by stimulating the liver to release glucose stored in the blood. This is opposed to the effect of insulin, which reduces blood sugar levels.

The efficacy and safety of Baqsimi were evaluated in 2 studies involving 83 and 87 adults with type 1 diabetes. The studies compared a single dose of Baqsimi to a single dose of glucagon injected by causing a glycemic response to hypoglycemia reduced to insulin. In both studies, Baqsimi increased participants' blood sugar levels. Similar results were obtained in a pediatric study in 48 children aged 4 years and older with type 1 diabetes.

The new antihypoglycemic agent should not be used in patients with pheochromocytoma, a rare tumor of the kidneys or adrenal glands, or insulinoma, a pancreatic tumor. Baqsimi should not be taken by anyone who is allergic to glucagon or its inactive components, betadex and dodecylphosphocholine. The drug contains a warning that it should not be used by patients who have been fasting for a long time or who have adrenal insufficiency or chronic hypoglycemia, as these conditions cause low levels of releasable glucose in the liver.

In addition, Baqsimi should not be taken by women who are badfeeding or who are planning to badfeed, as it is not known if glucagon pbades into bad milk.

The most common adverse reactions are nausea, vomiting, headache and upper respiratory tract infections, all similar to injectable glucagon. Patients with adrenal gland tumors treated with Baqsimi may experience peak blood pressure and patients with pancreatic tumors may have low blood sugar. In addition, nasal congestion, watery red eyes and itchy eyes, nose and throat may occur due to the intranasal administration of the drug.

The FDA warns that patients receiving Baqsimi and the caregivers who administer the medication should contact emergency medical badistance immediately after use and also inform the patient's health care provider.

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