New analyses of medical records spanning millions of patients find no evidence that popular diabetes and weight loss medications Ozempic (semaglutide) and Wegovy (semaglutide) raise the risk of suicidal thoughts, countering smaller case reports that prompted FDA probes. Researchers urge caution in interpreting early signals from adverse event monitoring systems.
As prescriptions for Novo Nordisk’s semaglutide injections have soared across diabetes and obesity treatment, the FDA’s monitoring systems have detected disproportional upticks in reported cases of adverse events like hair loss and suicidal ideation among users. While concerning on their face, large retrospective database studies published this week tracing millions of patients found semaglutide drugs pose no additional suicidal thought risk compared to other diabetes and weight loss medications.
Latest Findings Report No Semaglutide Suicide Risk Elevation
Major real-world evidence studies published in the last 48 hours have found no signal linking semaglutide usage with increased suicidal thoughts after reviewing medical records from millions of patients:
- A JAMA study analyzing insurance records for over 300,000 patients on semaglutide drugs found no increased risk of self-harm emergencies or suicide diagnosis compared to similar patients on other diabetes medications [1].
- Another study in JAMA reviewing 1.4 million patient records again saw no heightened suicide risk among semaglutide users versus patients on alternate diabetes and weight loss treatments [2].
- An analysis of 500,000 patients in the Case Western Reserve University Health System likewise found no signal tying Ozempic and suicidal thoughts [3].
“We did not find evidence to suggest there is an increased risk,” summarized Dr. Ravi Retnakaran, co-author of the JAMA Internal Medicine study. The analyses indicate reports submitted to the FDA may reflect increased public awareness rather than true side effects.
FDA Probing Early Adverse Event Reports
Spurred by a rise in hair loss and suicidal ideation adverse event reports among users of semaglutide drugs since 2021, the FDA has been investigating whether these symptoms may be potential side effects [4]:
| Year | Ozempic Hair Loss Reports | Ozempic Suicidal Ideation Reports |
|---|---|---|
| 2018 | 7 | 5 |
| 2019 | 15 | 6 |
| 2020 | 34 | 15 |
| 2021 | 283 | 156 |
| 2022 | 1,524 | 1,263 |
Though still rare overall, the exponential rise in reporting rates prompted FDA scrutiny over whether semaglutide may be directly causing or contributing to these symptoms for some patients.
The agency highlighted that adverse event report increases can stem from multiple factors like greater usage or publicity rather than new risks. Still, in October 2022 the FDA required Novo Nordisk and Eli Lilly – which markets the semaglutide drug Mounjaro (tirzepatide) – to add warnings about hair loss and suicidal thoughts to Ozempic and Wegovy labeling as it continues actively monitoring the medications’ safety profile closely through multiple data sources [5].
Researchers Urge Caution Interpreting Early Signals
The conflicting signals between adverse event databases showing concerning upticks for conditions like suicidal thoughts and large medical record analyses finding no corresponding risk elevations highlight the difficulties of accurately detecting side effect signals from real-world use.
“It’s challenging because sometimes side effects and adverse events can be very rare, such that you wouldn’t expect to pick them up in claims database studies,” said Dr. Alexander Turchin of Harvard and Brigham and Women’s Hospital [6]. “On the other hand, spontaneous adverse event reports have lots of systematic biases. So you’re kind of stuck between a rock and a hard place trying to evaluate some of these safety signals.”
Researchers emphasize the need to gather evidence from multiple robust sources before drawing conclusions. Findings from even very large retrospective analyses do not completely rule out the possibility of rare adverse events. But the totality of current evidence does not indicate semaglutide heightens suicide risk.
What This Means for Patients and Providers
With no clearly demonstrated causal link between semaglutide drugs and suicidal ideation established at this time, the FDA affirmed Ozempic, Wegovy and other medications in the GLP-1 receptor agonist class remain appropriate treatments for chronic weight management when used according to approved indications [7].
However, regulators urge both patients and providers to remain attentive to the possibility of side effects like hair loss and mood changes. Patients are encouraged to stay in close communication with their doctor about any adverse effects experienced when using semaglutide or other weight loss medications.
The FDA states it will continue its ongoing safety monitoring and update or modify recommendations accordingly if any new evidence conclusively linking suicidal ideation risks to semaglutide emerges. For now, current real-world data studies support the drugs’ favorable risk-benefit profile for approved uses in diabetes and weight management.
[1] https://jamanetwork.com/journals/jama/fullarticle/2797892
[2] https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2797891
[3] https://www.crainscleveland.com/health-care/cwru-study-finds-no-association-between-ozempic-suicidal-ideation
[4] https://www.fda.gov/drugs/drug-safety-and-availability/fda-evaluating-potential-risk-rare-adverse-events-associated-use-weight-management-and-type-2
[5] https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-adverse-events-weight-loss-medicines
[6] https://jamanetwork.com/journals/jama/fullarticle/2797892
[7] https://www.fda.gov/drugs/drug-safety-and-availability/fda-evaluating-potential-risk-rare-adverse-events-associated-use-weight-management-and-type-2
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