Ozempic is investigated for provoking suicidal thoughts – 07/10/2023 – Equilibrium
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Europe’s medicines regulator has told the BBC it is investigating some weight-loss drugs after receiving warnings about a possible link to thoughts of suicide and self-harm among users.
Iceland has notified the European Medicines Agency (EMA) of three cases in the country.
The entity will investigate Wegovy, Saxenda and other similar drugs – such as Ozempic – that help reduce appetite.
Product inserts already list “suicidal thoughts” as a possible side effect.
The EMA Pharmacovigilance Risk Assessment Committee (PRAC), which is leading the investigation, will consider whether other treatments in the same broader category of drugs – the glucagon-like peptide-1 (GLP-1) receptor agonist chemicals – also need to be evaluated.
However, initially, the committee will only assess the risks of using weight loss medicines that contain semaglutide or liraglutide.
An EMA official said: “The review is being carried out in the context of an alert raised by the Icelandic Medicines Agency following three case reports.”
Product inserts already list “suicidal thoughts” as a possible side effect.
The EMA Pharmacovigilance Risk Assessment Committee (PRAC), which is leading the investigation, will consider whether other treatments in the same broader category of drugs – the glucagon-like peptide-1 (GLP-1) receptor agonist chemicals – also need to be evaluated.
However, initially, the committee will only assess the risks of using weight loss medicines that contain semaglutide or liraglutide.
An EMA official said: “The review is being carried out in the context of an alert raised by the Icelandic Medicines Agency following three case reports.”
-“Case reports included two cases of suicidal thoughts – one after using Saxenda and one after using Ozempic.”
“An additional case was about thoughts of self-harm with Saxenda. EMA will communicate more information when available.”
global scarcity
Posts on social media about people – some of them celebrities – losing a lot of weight have led to a huge demand for these types of treatments in different parts of the world.
Saxenda and Wegovy are approved and licensed for weight loss and are available in Brazil on the private network.
Ozempic, approved and marketed in Brazil for the treatment of type 2 diabetes, is a medicine that helps control blood sugar, as well as weight, but contains a smaller dose of the same principle as Wegovy – semaglutide.
As many people without diabetes are buying Ozempic injection pens to lose weight, there has been a global shortage of the product.
All medications have potential side effects. For weight loss medications, which should be used along with a healthy diet and exercise, the most common ones include:
- nausea
- vomit
- headaches
- diarrhea
- cold
- stomachache
- tiredness
Depression or suicidal thoughts are listed in the package insert, which advises users: “You should pay attention to any mental changes, especially sudden changes in your mood, behavior, thoughts or feelings. Call your doctor immediately if you have any mental changes that new, worse, or that worries you”.
Physicians who prescribe these drugs are also advised to monitor this in their patients.
Manufacturer Novo Nordisk is said to be working with the European regulatory agency and says patient safety is a priority. A representative said: “GLP-1 receptor agonists have been used to treat type 2 diabetes for over 15 years and for the treatment of obesity for eight years, including Novo Nordisk products such as semaglutide and liraglutide.”
“Safety data collected from large clinical trial programs and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and thoughts of suicide and self-harm.”
“Novo Nordisk is continuously conducting surveillance of data from ongoing clinical trials and real-world use of its products and collaborates closely with authorities to ensure patient safety and adequate information to healthcare professionals.”
“EMA continuously monitors safety signals, as does Novo Nordisk.
“Novo Nordisk remains committed to ensuring patient safety.”
The UK’s medicines regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), said it was monitoring the situation.
BBC News Brasil approached the National Health Surveillance Agency (Anvisa) to ask if any similar evaluation takes place in Brazil and was waiting for a response until the publication of this report.
This text was published here
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