EU investigates slimmers Ozempic and Saxenda for suicidal ideation complaints

EU investigates slimmers Ozempic and Saxenda for suicidal ideation complaints

The European Medicines Agency (EMA) is investigating medicines for slim down Ozempic and Saxenda of Novo Nordisk, after several cases of patients with suicidal ideation or self-inflicted injuries were reported.

A safety committee is looking into adverse effects reported by the Icelandic Medicines Agency, including two cases of drug-related suicidal ideation Ozempic and Saxenda of Novo Nordisk, reported the EMA.

Another patient who used SaxendaNovo’s first weight-loss medication and which has another active ingredient, reported self-injurious thoughts, according to the agency.

Novo Nordisk said that patient safety was its top priority and that it treated all reports of adverse events very seriously.

The security data did not show any “causal association” between suicidal or self-harm thoughts and drugs, he added in a statement.

The EMA is investigating the possible side effects of medicines containing the active substances semaglutide or liraglutide for weight loss.

Suicidal behavior is not currently listed as a side effect in the EU data for these treatments.

The EMA will study whether the research should be extended to also include other medicines from the same class known as GLP-1 receptor agonists.

In the United States, the instructions for Wegovy recommend that patients be monitored for suicidal thoughts or behavior.

According to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) Public Panel, there have been at least 60 reports of suicidal ideation since 2018, either from patients taking semaglutide or from providers of medical care.

Novo’s anti-obesity medicines Wegovy and Ozempic, approved for diabetic patients, contain the active substance semaglutide, while Saxenda contains liraglutide.

The European review comes weeks after the regulatory body issued a thyroid cancer safety advisory, a mechanism to monitor possible adverse effects of several of Novo’s semaglutide-containing products.

Source: Gestion

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