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European Regulators Investigating Risk for Suicidal Thoughts With Popular Weight-Loss Drugs

Medically reviewed by Drugs.com.

By Physician’s Briefing Staff HealthDay Reporter

TUESDAY, July 11, 2023 -- The European Medicines Agency is investigating concerns that popular weight-loss drugs like Ozempic and Saxenda may be linked to suicidal thoughts and thoughts of self-harm.

Three case reports from Iceland spurred the agency's safety committee to conduct a medication review, CNN reported Monday. The Icelandic Medicines Agency reported two cases of suicidal thoughts. One happened after use of Ozempic (semaglutide) and the other after taking Saxenda (liraglutide). The third report was about Saxenda and thoughts of self-injury.

Both drugs are made by Novo Nordisk. The company said, "patient safety is a top priority," adding it takes "all reports about adverse events from use of our medicines very seriously," CNN reported.

Prescribing information in the United States for Saxenda includes a recommendation to monitor patients for depression or suicidal thoughts, but Ozempic does not carry a similar warning. The weight-loss drug Wegovy (semaglutide, the same active ingredient as in Ozempic) includes in its prescribing information that reports of suicidal behavior and ideation have occurred in clinical trials with other weight-management medications, the news report said.

Clinical trials in adults for Saxenda revealed that nine people among 3,300 reported suicidal ideation, while two in 1,900 reported suicidal ideation while on a placebo in those drug trials, CNN reported. One adult taking Saxenda attempted suicide, the prescribing information says. In pediatric clinical trials, one person died of suicide among 125 trial participants. However, "there was insufficient information to establish a causal relationship to Saxenda," according to the prescribing information.

The agency is continuing to monitor the medications and evaluate them through its risk-assessment programs, CNN reported. The European Medicines Agency safety committee will consider whether its review should extend beyond the drugs in question to other medicines in the class of glucagon-like peptide-1 receptor agonists. This could include Wegovy and Eli Lilly's Mounjaro.

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2024 HealthDay. All rights reserved.

Posted July 2023

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