The European Union’s drugs regulator has told BBC News that it is reviewing some weight-loss injections after receiving information about a possible link to suicidal and self-harm thoughts among users.
After seeing three cases, Iceland notified the European Medicines Agency. Wegovy, Saxenda, and similar drugs that help curb appetite, such as Ozempic, will be evaluated for safety. Suicidal thoughts are already listed as a possible side effect on product packaging. These prescription drugs are not currently approved for suicidal behavior.
The review will be conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which will consider whether other treatments in the same broader category of medicines, glucagon-like peptide-1 (GLP-1) receptor agonists, also require evaluation.
However, it will initially only assess the risks of using weight-loss medication containing 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.”
Social media posts about people, often celebrities, losing significant amounts of weight have resulted in a high demand for this type of treatment.
Weight loss medications Saxenda and Wegovy have been approved and licensed. Wegovy is not yet available in the UK, but the prime minister has stated that GPs in England, as well as specialist weight-management clinics, may soon begin offering it to some patients.
Ozempic is a diabetes medication that helps control blood sugar and weight. It contains a lower dose of the same medicine, semaglutide, as Wegovy. With some people without diabetes purchasing the pre-filled pens to lose weight, global shortages have persisted.
We all know that all medications may cause side effects. Weight-loss medications that should be used in conjunction with a healthy diet and exercise include nausea, vomiting, headaches, diarrhoea, constipation, stomach ache, and exhaustion.
Novo Nordisk pharmaceutical manufacturer, for a change, said that during their large clinical-trial programmes, the safety data collected and post-marketing surveillance have not demonstrated a causal assocation between semaglutide or liraglutide and suicidal and self-harming thoughts.
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.
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