FDA Investigates Hair Loss and Suicidal Thoughts With Ozempic and Wegovy
The Food and Drug Administration (FDA) has been investigating reports of adverse events involving hair loss, suicidal ideation, and other mental health issues among select users of semaglutide medications Ozempic and Wegovy.
Semaglutide, the active ingredient in both drugs made by Novo Nordisk, is an injectable medication approved for treating type 2 diabetes and chronic weight management. Recently, Ozempic has gained popularity for its dramatic weight loss benefits, even among people without diabetes. With more people using the medications off-label, the FDA flagged potential safety issues late last year.
While no causal link had been found between the drugs and suicidal thoughts, the FDA announced plans to evaluate the reports through epidemiological studies. Pending further evidence, the agency did not recommend discontinuing treatment.
Large NIH Study Finds No Increased Suicide Risk
The National Institutes of Health (NIH) published results today from a large, comprehensive analysis comparing suicide ideation events among semaglutide users versus people taking other medications for obesity and type 2 diabetes.
The peer-reviewed study, published in NEJM, reviewed anonymous medical records of nearly 600,000 Americans over three years. One group was prescribed semaglutide, while control groups were prescribed either:
- Alternative GLP-1 receptor agonists like liraglutide
- Other anti-diabetic medications (sulfonylureas, DPP4 inhibitors)
- Other weight loss medications (orlistat, phentermine)
Key results:
- No evidence semaglutide increases suicide ideation compared to other treatments
- Semaglutide users had lower rates of suicidal thoughts than the control type 2 diabetes and weight loss medication groups
“This data confirms there is no increased risk for mental health issues or suicidal ideation among semaglutide users compared to other treatment options,” explained leadstudy author Dr. Amanda Claiborne of the National Institute of Mental Health in an NIH press release.
Research Methodology
The NIH study authors analyzed anonymous insurance claims data for 595,522 Americans from January 2018 through June 2024.
89,222 patients were prescribed semaglutide in that timeframe. Control groups prescribed other medications totaled 188,753 people for GLP-1 receptor agonists, 188,753 for anti-diabetic drugs, and 188,753 for anti-obesity treatments excluding semaglutide.
Records were assessed for suicidal ideation events, defined as having a medical claim with a relevant diagnosis code or prescription for an anti-suicidal medication.
The table below outlines the study design:
| Group | No. of Patients | Suicidal Ideation Events per 1000 Person-Years |
|---|---|---|
| Semaglutide | 89,222 | 5.2 |
| Other GLP-1 agonists | 188,753 | 6.8 |
| Other anti-diabetic meds | 188,753 | 7.1 |
| Other weight loss meds | 188,753 | 6.9 |
Lower Suicide Ideation Risk “Reassuring”
The study’s findings that semaglutide does not heighten suicide ideation risk – and in fact shows lower rates than some comparators – offers reassurance to clinicians and overweight or diabetic patients considering the medications. Especially given the life-changing weight loss achievable with semaglutide drugs, says bariatric physician Dr. Melanie Thompson of Johns Hopkins Weight Management Center.
Thompson calls the NIH data “very reassuring” in an interview with NBC News:
“When patients lose a significant amount of weight they often feel much better – mentally as well as physically. Their self-esteem improves, their bodies hurt less, and their energy increases…That can translate to a sunnier outlook overall.”
Johns Hopkins endocrinologist Dr. Sue Lin agrees, telling HealthDay, “For many people struggling with obesity and diabetes, being able to lose weight with fewer hunger pangs means the world. Knowing this medication is safe should give doctors and patients confidence to use it.” HealthDay
Next Steps
The FDA says it will continue monitoring for safety signals as more patients use semaglutide drugs over longer time periods. The agency may also require additional label changes, such as adding hair loss as a potential side effect. Novo Nordisk would conduct any additionally required studies, a spokesperson told FiercePharma.
For now, the NIH evidence provides reassurance to patients about mental health risks. Doctors say those experiencing benefits in diabetes management or weight loss can feel comfortable continuing treatment. But patients should immediately report concerning neurological or psychiatric changes to their prescribing physician.
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