FDA Clears Wegovy, Different GLP-1 Medicine of Suicidality Threat for Now

— Preliminary analysis reassures, whereas the company’s overview continues

by
Kristen Monaco, Senior Workers Author, MedPage At the moment
January 11, 2024

GLP-1 receptor agonists possible do not trigger suicidal ideas or actions, based on a preliminary evaluation by the FDA.

The investigation was prompted after the FDA Antagonistic Occasion Reporting System obtained a number of reviews of suicidal ideation from customers over the previous few months, although this wasn’t a security sign seen in any scientific trials or observational research of those medicine. The European Medicines Agency introduced its personal ongoing overview of the difficulty, too.

The FDA stated that whereas it “can not definitively rule out {that a} small threat could exist” at the moment, its preliminary analysis doesn’t counsel a causal hyperlink. “We are going to talk our last conclusions and proposals after we full our overview or have extra data to share,” the company famous in its security communication.

Brokers within the GLP-1 agonist class embody exenatide (Byetta, Bydureon BCise), liraglutide (Victoza), dulaglutide (Trulicity), lixisenatide (Adlyxin), semaglutide (Ozempic, Rybelsus, Wegovy), and tirzepatide (Mounjaro, Zepbound), a twin GIP/GLP-1 receptor agonist. These brokers carry indications for treating sort 2 diabetes, weight problems, or each.

Just lately revealed retrospective analyses helped assuage suicidality issues, exhibiting that sufferers taking semaglutide (Wegovy) had a considerably decrease threat of suicidal ideation in contrast with these on non-GLP-1 anti-obesity drugs (0.11% vs 0.43%; HR 0.27, 95% CI 0.20-0.36).

As a part of its continued investigation, the FDA plans to conduct a meta-analysis of GLP-1 drug scientific trials and an evaluation of postmarketing information.

Within the meantime, healthcare professionals ought to monitor for and warn sufferers on GLP-1 medicine about new or worsening melancholy, suicidal ideas, or any uncommon adjustments in temper or conduct. “Healthcare professionals ought to seek the advice of the prescribing data when treating sufferers with these drugs,” the company suggested.

As for sufferers, they should not cease taking these medicine with out first consulting their healthcare supplier. Sufferers ought to inform their supplier in the event that they’re experiencing new or worsening melancholy, suicidal ideas, or any uncommon adjustments in temper or conduct.

Each sufferers and suppliers can report uncomfortable side effects involving GLP-1 receptor agonists or different medicines to the FDA MedWatch program.

When you or somebody you understand is contemplating suicide, name or textual content 988 or go to the 988 Suicide and Crisis Lifeline website.