GLP-1 drugs not linked to suicidal thoughts in FDA’s early review

A preliminary evaluation by the Food and Drug Administration did not find evidence that GLP-1 drugs like Ozempic and Wegovy cause suicidal thoughts or actions.

The regulator has been reviewing reports of patients experiencing suicidal ideations while using this class of diabetes and obesity treatments, but because there was limited information provided and because other factors could be influencing the suicidal thoughts, the FDA determined that there was no clear link to the drugs, it said in a post Thursday. A review of trials and studies conducted on the medications also didn’t find a link to suicidal thoughts and actions.

The FDA said it can’t definitively rule out that a small risk may exist, though, and so it’s continuing to investigate these reports and will share final conclusions. The agency has also been reviewing reports of hair loss and aspiration, in which food or liquid enter the airway, among people using the treatments.

GLP-1-based drugs like Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound have exploded in demand for helping people lose unprecedented amounts of weight. As more people have taken the treatments, though, anecdotal reports of suicidal ideations have arisen, leading researchers and regulators to probe the issue.

The European Medicines Agency has also been studying instances of suicidal thoughts. It said last month it hasn’t found a link to the drugs, but will continue to investigate and talk to drugmakers.

Earlier obesity treatments have been dogged by fears of psychiatric risks. For example, rimonabant was pulled off European markets in 2008 due to concerns that it raised the risk of suicidal thoughts.

The FDA labels for Wegovy and Zepbound, which are approved for obesity, already warn doctors to monitor patients for suicidal thoughts, while the labels for Ozempic and Mounjaro, which are approved for type 2 diabetes, don’t contain that warning.

A recent observational study in Nature Medicine, though, found that there was a lower risk of suicidal ideations linked to GLP-1 drugs than for other obesity and diabetes treatments.

Andrew Joseph contributed reporting.

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