European regulators find no evidence of link between new obesity medicines and suicidal thoughts

LONDON — Following a nine-month investigation, European regulators said Friday they have found no evidence that GLP-1 drugs like Ozempic and Wegovy cause suicidal thoughts or actions. 

The announcement from the European Medicines Agency echoes the findings of a review by the U.S. Food and Drug Administration, which in January said it did not find a causal relationship between the class of weight loss and diabetes medications and suicidal ideation. 

The EMA’s review started last July following anecdotal reports of patients experiencing thoughts of self-harm while on liraglutide (a branded version is Novo Nordisk’s Saxenda) and semaglutide (Novo’s Ozempic and Wegovy). In November, the EMA’s Pharmacovigilance Risk Assessment Committee requested additional details from the makers of a number of GLP-1 drugs.  

As part of their review, the committee analyzed medical records, clinical trials, post-marketing surveillance data, and other studies, including a recent Nature Medicine paper that found that there was a lower risk of suicidal ideation linked to GLP-1 drugs than for other obesity and diabetes treatments. Overall, the committee said that the results of their evaluation “did not support a causal association between the use of GLP-1 receptor agonists and this risk” of suicidal ideation.

The EMA said that GLP-1 makers are required to continue to monitor for any events of suicidal thoughts or actions going forward.

GLP-1-based drugs like Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound have exploded in popularity in recent years. As more patients started taking the drugs, however, there were a number of anecdotal reports of suicidal ideation, leading to the investigations. 

In its January statement, which was based on a preliminary review, the FDA said it couldn’t definitively rule out that a small risk of suicidal thoughts and actions may exist. It said it was continuing to investigate.

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.