EMA to Review Diabetes and Weight-Loss Drugs for Suicidal Ideation Risk

EMA building_iStock, Lubo Ivanko

Pictured: The EMA's logo at their former headquarters in London/iStock, Lubo Ivanko

The European Medicines Agency is set to review several diabetes and weight-loss treatments this week in connection with potential increased risk of suicidal ideation and self-harm, according to a draft agenda document of the agency’s Pharmacovigilance Risk Assessment Committee.

Novo Nordisk’s best-selling GLP-1 receptor agonist semaglutide, sold as Ozempic for type 2 diabetes and Wegovy for chronic weight management, is part of the review. The list also includes Novo’s Rybelsus (semaglutide), Saxenda (liraglutide) and Victoza (liraglutide), as well as Eli Lilly’s Trulicity (dulaglutide) and AstraZeneca’s Byetta (exenatide).

The European regulator first launched its investigation into the potential suicidality risk associated with the medications in July 2023. The review was triggered by the Icelandic Medicines Agency, which detected several reports of suicidal thoughts and self-injury among people taking Saxenda and Ozempic.

At the time, authorities flagged around 150 cases of self-harm and suicidal ideation that could potentially be linked to the medications.

In December 2023, the Pharmacovigilance Risk Assessment Committee (PRAC) announced that it had reviewed available evidence regarding thoughts of self-harm and suicide associated with GLP-1 receptor agonists and found that “at this point no conclusion can be drawn on a causal association.”

Still, the PRAC pointed to “several issues that need to be clarified” and asked the drugmakers under review to provide “further clarifications” regarding their products.

In January 2024, the FDA also started looking into the potential suicidality risks of GLP-1 receptor agonists, as well as other potential side effects such as alopecia and aspiration. The review included Novo’s semaglutide and Lilly’s tirzepatide, which is marketed as Mounjaro for type 2 diabetes and Zepbound for obesity.

The FDA’s probe followed the detection of safety signals in the agency’s Adverse Event Reporting System from July 2023 to September 2023.

The review returned preliminary results showing that there was no link between GLP-1 treatments and suicidal thoughts. Nevertheless, the FDA has advised physicians and other healthcare professionals to closely monitor their patients for thoughts of self-harm, worsening depression or otherwise worrying changes in mood or behavior.

GLP-1 receptor agonists have become some of the most lucrative products in the biopharma industry. Novo Nordisk and Eli Lilly are currently the most dominant forces in this space and are expected to capture around 80% of the market share by 2030.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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