FDA approves weight management drug for patients aged 12 and older
The U.S. Food and Drug Administration has approved Saxenda (liraglutide) for chronic weight management among patients aged 12 and older who are obese, as defined by specific body mass index (BMI) cut-offs for age and sex that correspond to a BMI 30 kg/m2 or higher for adults, and who weigh more than 60 kg (132 pounds). Saxenda is an adjunct (additional therapy) to a reduced-calorie diet and greater physical activity.
Saxenda contains liraglutide and should not be administered with other liraglutide-containing products, nor with any other GLP-1 receptor agonist. Use of Saxenda for pediatric patients with type 2 diabetes has not been established. The drug has also not been proven to treat weight loss in combination with other products (such as prescription drugs, over-the-counter drugs, and herbal preparations).
There is a boxed warning on the Saxenda prescribing information about the risk of thyroid c-cell tumors. The most common adverse reactions reported in the pediatric clinical trial included gastrointestinal side effects (such as nausea, vomiting, and diarrhea), dizziness and fever. There was one suicide in the trial in the Saxenda treatment group, so patients should be monitored for depression and suicidal thoughts. Additionally, hypoglycemia (low blood sugar) occurred in 15% of patients receiving Saxenda compared to 4% of patients receiving placebo. Treatment should be discontinued if pancreatitis (pancreas inflammation) is suspected. Patients should also be monitored for acute gallbladder disease, heart rate increase, kidney impairment, and hypersensitivity (allergic) reactions.
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