Ozempic: European body rules out link to suicide – 04/12/2024 – Equilíbrio
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The European Union’s medicines regulatory body announced this Friday (12), after a nine-month investigation, it found no evidence that semaglutide, a class of drugs for diabetes and weight loss, is associated with suicidal thoughts.
The same analysis had already been discarded in a study in the United States.
Semaglutide is the compound present in Ozempic and Wegovy, from the pharmaceutical company Novo Nordisk.
After reviewing the available evidence, the agency’s Pharmacovigilance Risk Assessment Committee, responsible for monitoring drug side effects, declared that there is no need for updates to product information. Following the announcement of these findings by the EMA (European Medicines Agency), shares in Novo Nordisk, a Danish pharmaceutical company, increased by almost 2%.
The finding comes after the agency in December extended its review of the class of weight-loss and diabetes drugs known as GLP-1 receptor agonists. These medications work by delaying gastric emptying and increasing the feeling of satiety. The EMA requested more data from manufacturers to better understand the issue.
The review began in July after Iceland’s health regulator identified three cases of patients reporting suicidal thoughts or self-harm while using such medications. The review focused on drugs containing semaglutide or liraglutide, both of which target GLP-1.
Liraglutide is the active ingredient in weight loss treatment from Novo Nordisk and Saxenda, while semaglutide is the active ingredient in Ozempic, the best-selling diabetes treatment, and Wegovy. The EMA analyzed the results of an extensive US study and did not find a direct association between semaglutide use and suicidal thoughts.
Results from another study conducted by the EMA also did not support a relationship between GLP-1 medications and the risk of suicidal thoughts. The surveys were based on electronic health records.
In January, the preliminary review by the FDA (responsible for regulating drugs and foods in the USA) reached the same result.
The GLP-1 receptor agonists, originally developed to help control blood sugar in patients with diabetes, in Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, also slow digestion and reduce appetite.
Ozempic, Wegovy and Mounjaro have so far proven to be relatively safe. Their clinical trials showed no risk of suicide. But doctors are on the lookout for previously undocumented dangers as thousands of new patients begin taking these weight-loss medications.
Increased risk of suicide has resulted in stern warnings about obesity medications. Another formula known as Acomplia, from Sanofi, without approval in the US, was withdrawn from the European market in 2008 due to association with suicidal thoughts.a
Additionally, in October, the Pharmacovigilance Risk Assessment Committee disclosed that it found no relationship between GLP-1 drugs and thyroid cancer after a review.
Where to seek care?
Psychosocial Care Network
Map shows the units in the network enabled by the Ministry of Health until September 2020
Mental Health Map
Website maps different types of service: www.mapasaudemental.com.br
CVV (Center for the Valuation of Life)
Volunteers answer free calls 24 hours a day on number 188: www.cvv.org.br.
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