FDA Clears Wegovy, Other GLP-1 Drugs of Suicidality Risk for Now

— Preliminary evaluation reassures, while the agency’s review continues

by
Kristen Monaco, Senior Staff Writer, MedPage Today
January 11, 2024

GLP-1 receptor agonists likely don’t cause suicidal thoughts or actions, according to a preliminary evaluation by the FDA.

The investigation was prompted after the FDA Adverse Event Reporting System received several reports of suicidal ideation from users over the past few months, though this wasn’t a safety signal seen in any clinical trials or observational studies of these drugs. The European Medicines Agency announced its own ongoing review of the issue, too.

The FDA said that while it “cannot definitively rule out that a small risk may exist” at this time, its preliminary evaluation does not suggest a causal link. “We will communicate our final conclusions and recommendations after we complete our review or have more information to share,” the agency noted in its safety communication.

Agents in the GLP-1 agonist class include exenatide (Byetta, Bydureon BCise), liraglutide (Victoza), dulaglutide (Trulicity), lixisenatide (Adlyxin), semaglutide (Ozempic, Rybelsus, Wegovy), and tirzepatide (Mounjaro, Zepbound), a dual GIP/GLP-1 receptor agonist. These agents carry indications for treating type 2 diabetes, obesity, or both.

Recently published retrospective analyses helped assuage suicidality concerns, showing that patients taking semaglutide (Wegovy) had a significantly lower risk of suicidal ideation compared with those on non-GLP-1 anti-obesity medications (0.11% vs 0.43%; HR 0.27, 95% CI 0.20-0.36).

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

In the meantime, healthcare professionals should monitor for and warn patients on GLP-1 drugs about new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior. “Healthcare professionals should consult the prescribing information when treating patients with these medications,” the agency advised.

As for patients, they shouldn’t stop taking these drugs without first consulting their healthcare provider. Patients should tell their provider if they’re experiencing new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.

Both patients and providers can report side effects involving GLP-1 receptor agonists or other medicines to the FDA MedWatch program.

If you or someone you know is considering suicide, call or text 988 or go to the 988 Suicide and Crisis Lifeline website.