APPETITE curbing jabs Wegovy, Saxenda and Ozempic are set to undergo a safety review following reports of a possible link to thoughts of suicide and self-harm among users.
The European Medicines Agency (EMA) will helm the investigation after it was alerted that three people experienced worrying side effects from the weight loss jabs that have taken the world by storm.
Iceland – who is a member state of the European drugs regulator – brought the three cases to the agency's attention.
Product leaflets for the prescription drugs already include suicidal thoughts in their list of possible side effects, but not suicidal behaviour.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is set to assess the risks of using medication that contains semaglutide – the main ingredient in Wegovy and Ozempic – or liraglutide, which Saxenda is made up of, the BBC reported.
But it will also consider whether similar treatments that use glucagon-like peptide-1 technology (GLP-1) to regulate appetite also need assessing.
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An EMA official told the BBC it was carrying out the review after receiving what is called a 'signal procedure'from Icelandic Medicines Agency, following three case reports.
They explained: "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.
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The official said the EMA would share more information once it was able to do so.
Novo Nordisk, the manufacturer of the drugs, told the BBC it was working with the EMA on the investigation and that 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."
They added that Novo Nordisk continuously keeps tabs on data from clinical trials and real-world use of its products and "continuously monitors for safety signals" in the same way that the EMA does.
The UK's own drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said it was also monitoring the situation and promised to communicate new advice to healthcare professionals and patients 'if appropriate'.
Dr Alison Cave, MHRA Chief Safety Officer, asked UK patients using the available drugs to flag any suspected side effects through the Yellow Card scheme website, and to seek immediate medical assistance if they experienced suicidal thoughts.
Ozempic is available on prescription in the UK to treat type 2 diabetes.
Wegovy – which contains a higher dosage of the ingredient semaglutide – has been approved for weight loss in the UK, though it hasn't yet been made available. But it is set to be prescribed by GPs under a two-year trial.
Saxenda, meanwhile, uses the appetite suppressing ingredient liraglutide and is offered by the NHS.
But it’s only available on Tier 3 and Tier 4 weight-management services, which means you have to be referred to weight-management clinics led by experts.
The most common side effects of the appetite suppressing drugs 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."
You’re not alone
If you’re struggling with suicidal thoughts, there is help available.
It could be helpful to speak to family and friends about what you're feeling – there's no right or wrong way to go about this.
You could also call a GP to ask for an appointment or call 111 out of hours and they will help you find the support and help you need.
The following helplines are open 24 hours a day:
- Samaritans – call 116 123 or email [email protected]
- Papyrus – prevention of young suicide HOPELINE247. Call 0800 068 41 41, text 07860 039967 or email [email protected]
- Childline – for children and young people under 19. Call 0800 1111 – the number will not show up on your phone bill
- SOS Silence of Suicide – call 0300 1020 505 – 4pm to midnight every day or email [email protected]
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