Europe’s drug regulator is investigating the risk of suicidal thoughts and thoughts of self-harm in patients using some weight loss and diabetes jabs.
The European Medicines Agency’s (EMA) safety committee said it is looking at cases among people who use a semaglutide or liraglutide-containing medicine for weight loss.
The safety assessment will examine Wegovy (semaglutide), Saxenda (liraglutide) and other similar drugs used to control appetite.
Suicidal behaviour is not currently listed as a side-effect in the EU product information of these medicines— European Medicines Agency
Another drug also under investigation, Ozempic (also semaglutide), is currently licensed for adults with poorly-controlled type 2 diabetes, as an add-on to diet and exercise.
The review is being carried out after concerns – or a “signal” – were raised by the Icelandic Medicines Agency following three case reports, the EMA said.
“A signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation,” the EMA added.
“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 semaglutide-containing medicine Wegovy and the liraglutide-containing medicine Saxenda are authorised for weight loss, together with diet and physical activity.
“Suicidal behaviour is not currently listed as a side-effect in the EU product information of these medicines.”
Wegovy, Ozempic and Saxenda are all manufactured by the pharmaceutical company Novo Nordisk.
The EMA will consider whether the review should be extended to also include other medicines of the same class (known as GLP-1 receptor agonists).
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
A Novo Nordisk spokeswoman said: “Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from use of our medicines very seriously.
“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.”
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said: “As with all medicines, the safety of medicines containing semaglutide and liraglutide is kept under continual review by the MHRA to ensure that the benefits outweigh the risks.
“As part of our close monitoring, any emerging evidence is routinely considered alongside other sources of information, including suspected adverse drug reactions.
“We will communicate any new advice to healthcare professionals and patients if appropriate.
“If you are experiencing suicidal thoughts or thoughts of self-harm, please seek immediate medical assistance.
“We ask everyone to report any suspected side effects using our Yellow Card scheme website.”
