Europe’s drugs regulator has told BBC News it is conducting a review of some weight-loss jabs after being alerted to a possible link to thoughts of suicide and self-harm among users.
Member state Iceland notified the European Medicines Agency after seeing three cases.
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The safety assessment will look at Wegovy, Saxenda and similar drugs, such as Ozempic, that help curb appetite.
Product leaflets already list suicidal thoughts as a possible side effect.
Suicidal behaviour is not currently listed for these prescription drugs.
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- The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which is conducting the review, will consider whether other treatments in same broader category of medicines, glucagon-like peptide-1 (GLP-1) receptor agonists, also need assessing.
- But initially, it will assess only the risks of 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.”
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Global shortages
Social media posts about people, often celebrities, shedding large amounts of weight has led to big demand for these types of treatment.
Saxenda and Wegovy are approved and licensed for weight loss. Wegovy is not yet available in the UK – but the prime minister has said GPs in England may soon start offering it to some patients, as well as specialist weight-management clinics.
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Ozempic is for people with diabetes to help control blood sugar as well as weight but contains a lower dose of the same medicine, semaglutide, as Wegovy. And with some people without diabetes buying the pre-filled pens to lose weight, there have been continuing global shortages.
All medicines have potential side effects. For weight-loss drugs, which should be used alongside a healthy diet and exercise, more common ones include:
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- nausea
- vomiting
- headaches
- diarrhoea
- constipation
- stomach ache
- tiredness
Depression or thoughts of suicide is 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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Prescribers are also advised to monitor for this.
Manufacturer Novo Nordisk is working with the EMA and says patient safety is a top priority. A representative 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.”
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The UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said it was monitoring the situation.
Dr Alison Cave, MHRA Chief Safety Officer, said: “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.
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“We ask everyone to report any suspected side effects using our Yellow Card scheme website.”
