The U.S. Food and Drug Administration (FDA) has approved two medications, Jardiance and Synjardy, as treatment options for children aged 10 and older with type 2 diabetes. This is significant, as children with type 2 diabetes have limited treatment options compared to adults. Type 2 diabetes is a chronic condition where the body does not make or use insulin properly, leading to high levels of glucose in the blood. The incidence of type 2 diabetes in children has been on the rise, with an expected increase in the coming years.
Jardiance and Synjardy contain the active ingredient empagliflozin, which works by increasing the excretion of glucose in the urine. The safety and efficacy of empagliflozin were studied in a double-blind, randomized, placebo-controlled trial involving 157 patients aged 10 to 17 with type 2 diabetes. The trial found that treatment with empagliflozin was superior to placebo in reducing average blood sugar levels (measured by hemoglobin A1c) and fasting plasma glucose levels.
Common side effects of empagliflozin in children were similar to those reported in adults, although there was a higher risk of hypoglycemia (low blood sugar) in pediatric patients taking empagliflozin compared to placebo. Common side effects in adults treated with empagliflozin include urinary tract infections and fungal infections in women. Metformin, another oral therapy for type 2 diabetes, is currently the only other option available for children with the condition.
Jardiance and Synjardy are not recommended for patients with type 1 diabetes or severe kidney problems. They should not be used by patients who have had a serious allergic reaction to them or those with metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).
Jardiance was originally approved by the FDA in 2014 for adults with type 2 diabetes, while Synjardy was approved in 2015. Both medications have additional indications for reducing the risk of cardiovascular death and hospitalization for heart failure in certain adult populations.
The FDA granted priority review designations for the approvals of Jardiance and Synjardy. This designation prioritizes the evaluation of applications for drugs that would be significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The FDA regulates the safety, effectiveness, and security of human and veterinary drugs, vaccines, medical devices, food, cosmetics, dietary supplements, and tobacco products. Its mission is to protect public health and ensure the safety of these products for use by consumers.
In conclusion, the FDA’s approval of Jardiance and Synjardy as treatment options for children with type 2 diabetes provides much-needed additional options for this population. The rise in the incidence of type 2 diabetes in children highlights the importance of expanding treatment options to address this growing health issue.
