Liraglutide Global Regulatory Status: FDA, EMA, and Post-Market Safety

What exactly has the FDA approved?

Two separate new drug applications, two different jobs.

Saxenda (NDA 206321) was approved on 23 December 2014 for weight management: with a reduced-calorie diet and more physical activity, to reduce excess body weight and maintain weight loss long term in adults and children aged 12 and older with body weight above 60 kg and obesity, and in adults with overweight plus at least one weight-related condition [1]. The recommended adult dose is 3 mg once daily; lower doses are for titration only [1].

Victoza (NDA 022341) was approved on 25 January 2010 for type 2 diabetes [2]. Its current label covers two uses: improving blood glucose in adults and children aged 10 and older with type 2 diabetes, and reducing the risk of major cardiovascular events (cardiovascular death, non-fatal heart attack, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease [2]. The maximum dose is 1.8 mg daily, and the 0.6 mg starting dose is not effective for glucose control [2]. Victoza is not approved for weight loss [2]. Saxenda is not indicated for glucose control, and its safety and effectiveness in children with type 2 diabetes have not been established [1].

Both are once-daily subcutaneous injections [1][2]. The Saxenda label says that coadministration with other liraglutide-containing products or any other GLP-1 receptor agonist is not recommended [1]. The Victoza label says the same for other liraglutide-containing products [2].

The boxed warning: thyroid C-cell tumours

Both labels open with the same boxed warning. Liraglutide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumours in both sexes of rats and mice at clinically relevant exposures; whether it causes thyroid C-cell tumours, including medullary thyroid carcinoma, in humans is unknown [1][2]. Both products are contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 [1][2]. The labels also state that routine serum calcitonin monitoring or thyroid ultrasound is of uncertain value for early detection, partly because of low test specificity and a high background rate of thyroid disease [1][2].

What changed in 2026: the suicidal thoughts warning came out

On 13 January 2026, FDA asked the makers of Saxenda, Wegovy and Zepbound to remove the suicidal ideation and behaviour language from their labels [6]. The request followed a review that included a meta-analysis of 91 placebo-controlled GLP-1 receptor agonist trials covering 107,910 patients (60,338 on a GLP-1 drug, 47,572 on placebo), a claims cohort of 2,243,138 new users, and published studies; FDA said it found no increased risk of suicidal ideation or behaviour with these medicines [6]. FDA also noted that GLP-1 labels for type 2 diabetes did not include that information in the first place [6].

The wording did change. The Saxenda label dated 26 January 2024 listed a Warnings and Precautions item headed Suicidal Behavior and Ideation, telling prescribers to monitor for depression or suicidal thoughts and to discontinue Saxenda if symptoms developed [8]. The Saxenda label effective 25 February 2026 runs its warnings from 5.1 thyroid tumours to 5.9 pulmonary aspiration with no such section, and the word "suicid" does not appear in the label text [1]. The Victoza label effective 14 October 2025 does not include a suicidal behavior and ideation warning [2]. One trace remains: a depression adverse reaction, 4% on Saxenda versus 2.4% on placebo, still appears in the paediatric trial table [1].

Cardiovascular outcomes and other safety content in the labels

The largest evidence behind a label indication came from LEADER, which randomised 9,340 adults with type 2 diabetes and high cardiovascular risk and followed them for a median of 3.8 years [9]. The composite of cardiovascular death, non-fatal heart attack or non-fatal stroke occurred in 13.0% of the liraglutide group versus 14.9% of the placebo group (hazard ratio 0.87, 95% CI 0.78 to 0.97); cardiovascular death was 4.7% versus 6.0% and death from any cause 8.2% versus 9.6% [9]. Victoza now carries a cardiovascular risk reduction indication [2].

Other label content reflects trial and post-marketing experience rather than new approvals:

• Gallbladder disease. In adult Saxenda trials, cholelithiasis was reported in 2.2% of Saxenda-treated patients versus 0.8% on placebo, and cholecystitis in 0.8% versus 0.4%; most affected patients needed gallbladder surgery, and the excess persisted after accounting for how much weight was lost [1].
• Heart rate. Mean resting heart rate rose 2 to 3 beats per minute; 34% of Saxenda-treated patients versus 19% of placebo patients had rises above 10 bpm at two consecutive visits, and 24-hour monitoring showed rates 4 to 9 bpm higher than placebo [1].
• Pancreatitis and kidney injury. Acute pancreatitis, including haemorrhagic and necrotising cases, has been reported with GLP-1 receptor agonists including liraglutide, and the labels say to discontinue if pancreatitis is suspected [1][2]. The Victoza label reports acute kidney injury, mostly after nausea, vomiting or diarrhoea led to dehydration [2].
• Pulmonary aspiration. Aspiration during general anaesthesia or deep sedation has been reported in patients receiving GLP-1 receptor agonists [1][2].

How the EMA position differs

The EMA has authorised both products [3][4]. Its Victoza information describes use in adults and children from 10 years with type 2 diabetes, either alone when metformin is not recommended or added to other diabetes medicines, starting at 0.6 mg and stepping to 1.2 mg after at least a week, then 1.8 mg a week later if needed [3].

The Saxenda information covers adults with a BMI of 30 or more, or 27 to 30 with weight-related complications such as diabetes, high blood lipids, high blood pressure or obstructive sleep apnoea; adolescents from 12 with obesity who weigh more than 60 kg; and, unlike the US label, children from 6 to under 12 with a BMI at or above the 95th percentile who weigh at least 45 kg [4]. The European stopping rule is also different: treatment should stop if patients have not lost at least 4% of initial weight (children and adolescents) or 5% (adults) after 12 weeks at the maximum dose or maximum tolerated dose, with the need to continue reassessed once a year [4]. The US Saxenda label instead evaluates adults at 16 weeks and says to stop if less than 4% of baseline body weight has been lost [1].

Generics, compounding and the bulk substances proposal

Generic liraglutide is FDA-approved. Generics referencing Saxenda include Teva (ANDA 214568), Biocon (ANDA 217063) and Cipla (ANDA 217234); generics referencing Victoza include Hikma (ANDA 215503, approved 23 December 2024), Lupin, Meitheal/NorthStar and a Teva authorised generic [5].

On 30 April 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the list of bulk substances that outsourcing facilities may compound with, finding no clinical need; comments were open to 29 June 2026, and FDA said it would consider them before making a final determination [7]. FDA states that compounded drugs are not FDA-approved [7], and an FDA-approved generic liraglutide exists [5].