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Two weight loss drugs are being investigated by the European Medicines Agency (EMA) following reports that some patients taking the medication experience suicidal thoughts or thoughts of self-injury.
The reports came from Iceland, where so far, there has been one case of suicidal thoughts following the use of Ozempic, one case of suicidal thoughts following the use of Saxenda, and one case of thoughts of self-injury with Saxenda.
While the drugs’ product leaflets already list suicidal thoughts as a possible side effect, the EMA will now conduct a safety assessment of Wegovy, Saxenda and similar drugs that contain either semaglutide or liraglutide.
Both drugs approved for type 2 diabetes patients in the UK
Novo Nordisk’s Ozempic (semaglutide) and Saxenda (liraglutide) are both available to UK patients with type 2 diabetes.
Both drugs blunt appetite by mimicking a hormone known as a glucagon-like-peptide (GLP-1), which is released after eating. It makes people using it feel full, thereby resulting in people eating less and reducing their overall calorie intake.
While Ozempic is not currently available as a weight loss medication in the UK, an application has been submitted to the regulatory authorities to allow the drug to be prescribed for weight loss, so it is likely it will be available as a weight loss medication in the future.
Furthermore, Wegovy, which is the same drug sold under a different brand name, has already been approved approved by the NHS for weight loss purposes.
Saxenda has also been approved as a weight loss medication in the UK, and is available to anyone with a BMI of 30 and over, or to patients with a BMI of 27 to 30 if they have another weight-related co-morbidity (such as high blood pressure, high cholesterol or sleep apnoea).
Novo Nordisk supporting EMA in its investigation
An EMA official said the review is being carried out in the context of a signal procedure raised by the Icelandic Medicines Agency, following three case reports of suicidal ideation and thoughts of self-injury.
“A signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation,” the official said in a statement.
The EMA says it will “communicate further when more information becomes available.”
The Danish drug manufacturer Novo Nordisk says it “remains committed to ensuring patient safety” and is working with the EMA to support its investigation.
A representative said: “GLP-1 receptor agonists have been used to treat type-2 diabetes for more than 15 years and for treatment of obesity for eight years, including Novo Nordisk products such as semaglutide and liraglutide that have been in the UK market since 2018 and 2009 respectively.
“The safety data collected from large clinical-trial programmes and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.
“Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals.
“EMA continuously monitors for safety signals and so does Novo Nordisk.”