Article
Weight-loss jabs investigated for suicide risk
Posted on the 13th July 2023
The European Medicines Agency (EMA) has commenced a review into several weight-loss jabs following an alert over a possible link to suicide among users.
It comes as member state Iceland notified the agency of three cases.
The new safety assessment will look at Wegovy, Saxenda, Ozempic and other similar drugs that help curb appetite.
While the current product leaflets list suicidal thoughts as a possible side effect, suicidal behavior is not mentioned.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which is conducting the review, will also consider whether other treatments in the broader category of medicines, glucagon-like peptide-1 (GLP-1) receptor agonists, now need assessing.
However, the initial study will only assess the risk involved in using weight-loss medication that contains either semaglutide or liraglutide.
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.
"A signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation.
"The case reports included two cases of suicidal thoughts - one following the use of Saxenda and one after Ozempic.
"One additional case reported thoughts of self-injury with Saxenda.
"The EMA will communicate further when more information becomes available."
As with all medicines, there is potential for side effects with weight-loss drugs.
The most common ones listed include nausea, vomiting, bowel habit changes and tiredness.
Depression or thoughts of suicide are also listed in the product information leaflet and prescribers are advised to monitor for these.
Manufacturer Novo Nordisk has confirmed it is working with the EMA and says patient safety is a top priority for them.
In a statement, the company 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.
"Novo Nordisk remains committed to ensuring patient safety."