Europe's drugs regulator investigating weight-loss jabs for suicide risk

Europe's drugs regulator has informed BBC News that it is carrying out a review of a few weight-loss jabs after it was alerted about the possibility of them leading to suicide and self-harm among users.

The European Medicines Agency (EMA) was notified about the development by member state Iceland after three cases emerged.

The safety assessment will investigate Wegovy, Saxenda and similar drugs like Ozempic that help in curbing appetite. Suicidal thoughts have already been listed on the product leaflets as a possible side effect.

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The EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which has been carrying out the review, will look into if other treatments in the same broader category of medicines, glucagon-like peptide-1 (GLP-1) receptor agonists also require assessment.

However, initially, it will only look into the risks of using weight-loss medication which contains either liraglutide or semaglutide.

"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 an information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation,” an EMA 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. The EMA will communicate further when more information becomes available,” he added.

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Social media popularising weight-loss treatment

Such types of treatment have been in great demand in the market because they have been popularised by social media that talk about people, often celebrities, losing large amounts of weight.

Saxenda and Wegovy have received approval and are licensed for weight loss. Wegovy is still not available in the UK market, however, the prime minister has said GPs may soon start giving it to some patients in England.

Thoughts of suicide and depression have been listed in the product-information leaflet which 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."

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A representative of manufacturer Novo Nordisk 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,” he added.

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