European drug safety officials have launched a probe into Ozempic after patients reported thoughts of suicide or self-harm.
On 10 July, the European Medicines Agency (EMA) told Reuters it is investigating adverse side effects into drug manufacturer Novo Nordisk’s the popular diabetes medication after Iceland’s health regulator flagged three cases of patients thinking about suicide or self-harm.
In addition to the type 2 diabetes injection, weight-loss drugs Wegovy and Saxenda will also be investigated by the regulator’s Pharmacovigilance Risk Assessment Committee (PRAC).
Ozempic works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The committee will assess the risks of weight-loss medications that contain semaglutide or liraglutide, the GLP-1 agonists that induce weight loss in a person by reducing energy intake.
It comes as the popularity of weight-loss drugs has led to a spike in demand for quick-fix treatments for obesity as influencers and celebrities promoted their use.
Saxenda and Wegovy are approved in the UK and the US for weight loss. While Wegovy is not available in the UK yet, the prime minister has said that physicians would be able to offer it to patients for diabetes and weight management.
An official of EMA told the BBC that 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 refers to information regarding a potential adverse event caused by a medication, whether it is already known or newly identified, that requires further investigation, the official said.
“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,” they added. “The EMA will communicate further when more information becomes available.”
The medicines list suicidal thoughts or depression as their side-effects along with nausea, vomiting, headaches, constipation, and others.
"You should pay attention to any mental changes, especially sudden changes in your mood, behaviours, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you,” a warning on the leaflet reads.
Leading healthcare company Novo Nordisk which manufactures all three weight-loss drugs said “it remains committed to ensuring patient safety” but defended the use of semaglutide and liraglutide.
“GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide that have been in the UK market since 2018 and 2009 respectively,” Novo Nordisk told The Independent.
"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.”
Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s drug regulator, said it is also monitoring the developments around the drug.
Alison Cave, MHRA chief safety officer, urged users to report any side effects of the drugs and seek immediate medical assistance in case of suicidal or self-harm thoughts.
If you are experiencing feelings of distress, or are struggling to cope, you can speak to the Samaritans, in confidence, on 116 123 (UK and ROI), email jo@samaritans.org, or visit the Samaritans website to find details of your nearest branch.
If you are based in the USA, and you or someone you know needs mental health assistance right now, call the National Suicide Prevention Helpline on 1-800-273-TALK (8255). This is a free, confidential crisis hotline that is available to everyone 24 hours a day, seven days a week.
If you are in another country, you can go to www.befrienders.org to find a helpline near you.
