After a few months of investigating reports of suicidal ideation with semaglutide-containing drugs Ozempic and Wegovy, the FDA has concluded — for now — that the drugs don’t cause thoughts of self-harm.
The FDA reviewed reports of suicidal thoughts or actions it had received from July to September 2023 in the FDA Adverse Event Reporting System (FAERS). In addition to reports from FAERS, the agency also reviewed data from clinical trials that included large observational studies. The FDA concluded there wasn’t enough evidence to find an association between GLP-1 drugs such as Ozempic, Wegovy, Mounjaro, Rybelsus and Zepbound and suicidal thoughts.
However, the FDA hasn’t reached a final ruling on the issue.
“Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions… However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue,” the FDA said in its Jan. 11, 2024, Safety Communication.
The agency is also investigating other concerning reports from FAERS such as alopecia (hair loss) and aspiration linked to Ozempic and Wegovy. Aspiration occurs when food or liquid enters the airway and lungs by accident.
Study Found Lower Risk of Suicidal Ideation with Semaglutide Versus Other Drugs
Just days before the FDA made its preliminary ruling on the connection between GLP-1 drugs and suicidal ideation, researchers from the National Institutes of Health and Case Western Reserve University published a study showing semaglutide had a lower risk of suicidal ideation compared to other obesity drugs and drugs for Type 2 diabetes.
The study, published by William Wang and colleagues in Nature Medicine, looked at data from about 1.6 million patients treated for diabetes and 240,000 patients treated for obesity or being overweight.
Researchers found that the risk of suicidal thoughts in people who took semaglutide was 49% to 73% lower than those taking another drug during a six-month follow-up period.
Ozempic’s Gastrointestinal Side Effects Lead To Lawsuits
While the FDA has so far cleared GLP-1 drugs of a link to suicidal ideation, gastrointestinal side effects such as gastroparesis, persistent vomiting and intestinal blockages have led many users to file Ozempic lawsuits against Novo Nordisk, the drug’s maker.
“People are alleging that Novo Nordisk and Eli Lilly failed to properly warn patients and their doctors about certain Ozempic side effects and risks of the drugs. We’re alleging that the Defendants knew or should have known that these drugs could cause what’s called gastroparesis, ileus and intestinal blockages, and they failed to properly warn the American population about it,” said Jonathan Sedgh of Morgan & Morgan, the firm that filed the first Ozempic lawsuit.
The firm is also pursuing lawsuits on behalf of people who took other GLP-1 drugs such as Mounjaro, Wegovy, Rybelsus and Saxenda.
On Sept. 22, 2023, the FDA required that Ozempic’s prescription label get a warning added to the drug’s label for ileus and intestinal blockages.