FDA expands Wegovy to patients 12 and older with obesity
Wegovy's FDA label now covers weight reduction and long-term weight maintenance in patients aged 12 and older with obesity, making semaglutide an option for some adolescents. [1]
The FDA expanded Wegovy (semaglutide) injection in December 2022 to include adolescents, based on the STEP TEENS trial. The current prescribing information lists the injection as indicated, along with a reduced-calorie diet and increased physical activity, "to reduce excess body weight and maintain weight reduction long term in" both "adults and pediatric patients aged 12 years and older with obesity." [1]
That pediatric wording appears throughout the label. The clinical studies section includes a dedicated subsection, 14.3, titled "Weight Reduction and Long-term Maintenance Study of WEGOVY Injection in Pediatric Patients Aged 12 Years and Older with Obesity," and there is a separate Pediatric Use section (8.4). [1] The adverse reactions summary also covers both age groups: the most common reactions reported at 5% or higher in adults or in pediatric patients 12 and older are nausea, diarrhea, vomiting, constipation, abdominal pain, dysesthesia, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation (burping), hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and hair loss. [1]
The specific trial results behind the adolescent approval — including average weight change and the exact BMI percentile threshold used to define obesity in this age group — are not spelled out in the label excerpt available here, so those figures are not confirmed by the source at hand. [1]
What the label says about dosing and risks
Wegovy injection is given under the skin once weekly, on the same day each week, at any time of day, with or without meals, in the abdomen, thigh, or upper arm. [1] The label describes starting at 0.25 mg once weekly for four weeks, then escalating every four weeks, with a usual recommended maintenance dosage of 2.4 mg once weekly; maintenance dosages vary by indication. [1] In patients with diabetes, the label directs blood glucose monitoring before and during treatment. [1]
Wegovy carries a boxed warning about thyroid C-cell tumors. In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures; whether it causes such tumors, including medullary thyroid carcinoma (MTC), in humans is unknown. [1] The drug is contraindicated in people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in those with known hypersensitivity to semaglutide or its ingredients. [1]
Other warnings in the label include acute pancreatitis, acute gallbladder disease, hypoglycemia when used with insulin or an insulin secretagogue, acute kidney injury from volume depletion, severe gastrointestinal reactions, hypersensitivity reactions including anaphylaxis and angioedema reported after marketing, diabetic retinopathy complications in type 2 diabetes, heart rate increase, and pulmonary aspiration during general anesthesia or deep sedation. [1] The label also notes semaglutide delays gastric emptying and may affect absorption of oral medications. [1]
Why it matters for patients
The expansion means a prescription weight-management drug that was previously limited to adults is, per its FDA label, also studied and labeled for use in 12- to 17-year-olds with obesity. [1] For families, that changes the conversation with a pediatrician or pediatric endocrinologist from "off-label" to an approved indication, and it can matter for insurance coverage decisions, though the label itself does not address coverage. [1]
It also means the same boxed warning, contraindications, and side-effect profile that apply to adults are part of the discussion for adolescents, since the label groups the common adverse reactions for adults and patients 12 and older together. [1] Gastrointestinal effects dominate that list. [1]
What happens next
The label has continued to change since the 2022 pediatric expansion. Recent major changes listed in the current prescribing information include updates to Indications and Usage in August 2025 and December 2025; Dosage and Administration in August 2025, December 2025, and March 2026; a new warning on acute kidney injury due to volume depletion in August 2025; severe gastrointestinal adverse reactions in October 2025; removal of the suicidal behavior and ideation warning in January 2026; and a warning in June 2026 against sharing the Wegovy FlexTouch pen between patients. [1] The label was last revised in June 2026. [1] Whether any of these later changes were driven by pediatric data is not stated in the source. [1]
Sources
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