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Pharmacist handing patient medication

FDA approves new type 2 diabetes medications for adolescents

June 21, 2023

Two new oral medications are available to treat adolescents with type 2 diabetes.

The Food and Drug Administration (FDA) approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) to improve blood sugar control in adolescents 10 years and older with type 2 diabetes. The medications should be used as additions to diet and exercise.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” Michelle Carey, M.D., M.P.H., associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”

The medications, which are from Boehringer Ingelheim Pharmaceuticals and Eli Lilly, are used in adults. Metformin is the only other oral therapy for children with type 2 diabetes. The new treatments come as type 2 diabetes cases in children are rising. There were about 28,000 children with type 2 diabetes as of 2017, according to the FDA. It predicts that figure could rise to 220,000 by 2060, with Black and Hispanic children making up most cases.

Both new medications include empagliflozin, which increases the excretion of glucose in urine. It was tested in a randomized, placebo-controlled trial in 157 children ages 10-17 years with type 2 diabetes. Patients taking empagliflozin had a 0.8% reduction in hemoglobin A1c as well as a reduction in fasting plasma glucose compared to placebo groups.

The most common side effects in adults are urinary tract infections and female fungal infections. Studies showed similar effects in adolescents. The pediatric group also had a higher risk of hypoglycemia compared to placebo.

Jardiance and Synjardy are not recommended for patients with type 1 diabetes, severe kidney problems or who have had a serious allergic reaction to the medications. Patients with metabolic acidosis or diabetic ketoacidosis should not take Synjardy.



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