Victoza and Saxenda labels remove pregnancy contraindication
Pregnancy is no longer listed as a contraindication on the Victoza and Saxenda labels, but both still describe fetal risk and give different instructions once a pregnancy is recognized.
Novo Nordisk's two liraglutide medicines no longer list pregnancy as a contraindication, according to their FDA-approved prescribing information. Both labels, Saxenda for weight management and Victoza for type 2 diabetes, record a May 2025 revision to their Indications and Usage sections in their Recent Major Changes blocks [1][2].
The Saxenda Recent Major Changes block also lists two removals dated 05/2025: the Patient Selection subsection under Dosage and Administration (2.1), and the Pregnancy contraindication (4) [1]. The Victoza block lists only the May 2025 Indications and Usage revision and does not record a pregnancy-contraindication removal [2]. Victoza's current Contraindications section lists two items: a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2, and serious hypersensitivity to liraglutide or the product's excipients [2].
Pregnancy is now addressed in Use in Specific Populations. Saxenda's label states, "Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue SAXENDA." [1] Victoza's states that the drug "should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." [2]
The two products have different approved uses. Saxenda is indicated, along with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or with overweight plus at least one weight-related condition, and in pediatric patients aged 12 and older with body weight greater than 60 kg and obesity [1]. Victoza is indicated to improve blood sugar control in adults and pediatric patients aged 10 and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease [2].
Other safety information is unchanged. Both labels keep a boxed warning about thyroid C-cell tumors seen in rats and mice, and the same MTC and MEN 2 contraindication [1][2]. Common adverse reactions listed for Saxenda include nausea, diarrhea, constipation, vomiting, injection site reactions, headache and hypoglycemia [1]; Victoza's list includes nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation [2].
The Saxenda label carries a revision date of 02/2026 and lists later changes, including a Warnings and Precautions entry for severe gastrointestinal adverse reactions dated 10/2025 and removal of a Suicidal Behavior and Ideation entry dated 02/2026 [1]. The Victoza label carries a revision date of 10/2025 and lists a severe gastrointestinal adverse reactions entry dated 10/2025 and a pulmonary aspiration entry dated 11/2024 [2].
Neither document explains why the pregnancy contraindication was removed, and no FDA statement or study data behind the change appears in the labeling. Whether other GLP-1 medicine labels have been changed in the same way has not been reported here.
Why it matters for patients
A contraindication is a formal statement that a drug should not be used in a given group. For pregnancy, that status meant the labels treated liraglutide as inappropriate for anyone pregnant, regardless of individual circumstances. Removing it moves the decision into the benefit-risk language that labels use in Use in Specific Populations, where a prescriber weighs the medicine against the situation at hand.
The change is not a statement that these drugs are safe in pregnancy. Both labels still describe risk to a fetus, and they now give different instructions: Saxenda's says to discontinue the drug once pregnancy is recognized [1], while Victoza's frames continued use as a judgment about benefit versus risk [2].
A person taking either product who is pregnant, or who is planning a pregnancy, is now covered by different label language than before May 2025, and the two labels no longer say the same thing. Anyone in that position can ask their prescriber what the current labeling says about their specific medicine, since Victoza and Saxenda are not interchangeable in how they address pregnancy [1][2].
Saxenda's removed Patient Selection subsection was part of Dosage and Administration; the label no longer carries that separate dosing subsection [1]. What it previously said about selecting patients has not been described in the current labeling.
Sources
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