There is no evidence weight-loss drugs like Wegovy and Ozempic are tied to suicidal ideation, the U.S. Food and Drug Administration said in its preliminary review released Thursday, Jan. 11.
“We determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs,” the FDA wrote.
However, the FDA stopped short of giving the medications a completely clean bill of health. While the data so far doesn’t demonstrate a link, the agency said it couldn’t definitively rule out a small risk either.
Adverse Event Reports Drive FDA Probe
The FDA’s investigation follows months of adverse event reports linking suicidal ideation to GLP-1 agonists, a class of medications used to treat type 2 diabetes and obesity.
According to the agency’s Adverse Events Reporting System database, known as FAERS, there have been nearly 17,000 reports of adverse events associated with Ozempic. Of those, 108 involved suicidal ideation, including nine suicide attempts and six completed suicides. Wegovy was reported for suicidal ideation 14 times.
However, the FDA said the information provided in these reports was too limited to draw conclusions. The agency noted suicidal thoughts could be attributed to other factors unrelated to the medications themselves.
Once niche diabetes treatments, GLP-1 agonists like semaglutides (Ozempic, Wegovy) and tirzepatides (Mounjaro) have surged in popularity for weight loss in recent years, partly driven by social media influencers. These drugs mimic the hormone GLP-1, which stimulates insulin release and reduces blood glucose after eating. This effect makes a person feel fuller for long.
The first GLP-1 was approved in 2005, for treatment of type 2 diabetes, but the class now includes multiple options. Wegovy, specifically approved for weight management for adults with obesity or overweight with at least one weight-related condition, is the only one that warns healthcare professionals to monitor for suicidal thoughts.
Too Soon to Draw Firm Conclusions
The FDA also reviewed clinical trials and studies of GLP-1 agonists. Their analysis did not uncover a clear connection between the medications and suicidal behavior or thoughts. However, the agency said it could not definitively rule out a small risk, as some suicidal behavior was observed in some people.
In all, the FDA is investigating 13 different GLP-1 receptor agonists. The Jan. 11 findings represent the first batch of results; reviews for the remaining 11 drugs are forthcoming. To reach its final conclusions, the agency plans to thoroughly analyze insurance claims data and patient health records. Recommendations will be announced once this comprehensive review is complete.
In the meantime, the FDA advised patients currently taking GLP-1 agonists not to stop without first consulting their healthcare provider. It is critical to report any new or worsening conditions, mood changes, or suicidal thoughts. Those experiencing suicidal crisis can call 988 or visit 988Lifeline.org, which provides free support for people in distress, 24 hours a day, seven days a week.
Prescribing physicians are also being instructed to monitor for signs of depression, suicidal ideation, and unusual behavioral changes in patients on GLP-1 agonists.
The FDA is also investigating whether these drugs cause alopecia, more commonly known as sudden hair loss, as well as aspiration. Aspiration occurs when you inhale water or food into the windpipe instead of down the esophagus.
The FDA is also investigating potential links between these medications and sudden hair loss (alopecia) and aspiration. Nearly 420 alopecia cases and 20 aspiration events have been reported, including food particles found in one patient’s lungs during surgery.
