Weight-loss jabs under investigation over ‘links to suicidal thoughts’ after three cases reported

Weight-loss jabs are being investigated over a possible link to thoughts of suicide and self-harm, Europe’s drugs regulator has warned.

The European Medicines Agency (EMA) told BBC News it is conducting a review of some weight-loss jabs after member state Iceland notified that it had seen three cases of suicidal thoughts.

The safety assessment by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will investigate drugs including Wegovy and Saxenda that help to curb appetite.

Suicidal thoughts is listed as a possible side effect on the product’s leaflets but suicidal behaviour is not currently listed.

On the leaflet it advises users: "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."

The PRAC will consider whether other treatments such as glucagon-like peptide-1 (GLP-1) receptor agonists, also need assessing but initially it will only investigate the risks of weight-loss medication that contains either semaglutide or liraglutide.

An EMA official 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 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."

Saxenda and Wegovy are approved and licensed for weight loss while Ozempic is for people with diabetes to help control blood sugar as well as weight.

Ozempic contains a lower dose of semaglutide like Wegovy which is not yet available in the UK.

Wegovy has been described by health experts as a “pivotal moment” for the treatment of people living with obesity, but others warned the drug is not a “quick fix”.

Wegovy has been used by the likes of Billionaire Elon Musk to keep in shape. Last October, Musk was asked by a Twitter user what his secret was to looking "fit, ripped, and healthy" to which he replied "fasting" and "Wegovy".

Patients inject themselves with the drug weekly, which suppresses the appetite through mimicking the hormone glucagon-like peptide-1 (GLP-1) that is released after eating. This makes people feel full, meaning they eat less and lose weight.

Charity Beat raised concerns about the impact of the drug on people with eating disorders. Tom Quinn, Beat’s director of external affairs, said: “Weight-loss medications like semaglutide can be extremely attractive to people with eating disorders as they appear to provide quick results.

“However, these medications can be very dangerous as they can worsen harmful thoughts and behaviours for those unwell, or contribute to an eating disorder developing for someone who is already vulnerable.”

It is advised that the weight-loss drugs are used alongside a healthy diet and exercise but they can cause side effects including nausea, vomiting, headaches, diarrhoea, constipation, stomach ache and tiredness.

Manufacturer Novo Nordisk is working with the EMA and says it “remains committed to ensuring patient safety."

It 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.”

It added that the firm is “continuously performing surveillance of the data from ongoing clinical trials” and “collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals.”

The UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said it was “monitoring” the situation and “will communicate any new advice to healthcare professionals and patients if appropriate.”

Dr Alison Cave, MHRA Chief Safety Officer, said: "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."