Europe’s drugs regulator, the European Medicines Agency (EMA), is conducting a review of weight-loss jabs following reports of a possible link to thoughts of suicide and self-harm, according to a report by BBC.
The review was initiated after Iceland, a member state, notified the EMA about three cases.
The safety assessment will focus on drugs like Wegovy, Saxenda, and Ozempic, which help suppress appetite.
While suicidal thoughts are already listed as a possible side effect in the product leaflets, suicidal behaviour is not currently listed.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will evaluate whether other drugs in the same category of medicines, known as glucagon-like peptide-1 (GLP-1) receptor agonists, also require assessment.
Initially, the review will specifically assess the risks associated with weight-loss medications containing semaglutide or liraglutide.
Concerns over weight-loss drugs and side effects
According to an EMA official, the Icelandic Medicines Agency raised a signal procedure following three case reports, which included instances of suicidal thoughts and self-injury related to the use of Saxenda and Ozempic.
The EMA will provide further updates as more information becomes available.
These weight-loss drugs have gained popularity due to social media posts about individuals, including celebrities, who have shed significant amounts of weight. Saxenda and Wegovy are approved and licensed for weight loss, with Wegovy awaiting availability in the UK.
Ozempic, on the other hand, is primarily prescribed to people with diabetes but has been used by some without diabetes for weight loss, leading to global shortages.
All medicines carry potential side effects, and common side effects for weight-loss drugs include nausea, vomiting, headaches, diarrhoea, constipation, stomach ache, and tiredness.
The product-information leaflet warns users to be attentive to any mental changes and advises seeking medical assistance for sudden mood changes, behaviours, thoughts, or feelings.
Novo Nordisk, the manufacturer of these drugs, emphasised on patient safety as a top priority and highlights that safety data from clinical trials and post-marketing surveillance have not shown a causal association between their products and suicidal or self-harming thoughts.
The UK’s drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), is monitoring the situation and will communicate any new advice to healthcare professionals and patients if necessary, the report said.
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