Dive Brief:

• The use of GLP-1-based drugs to treat obesity and diabetes has no “clear relationship” with the risk of suicidal thoughts or actions, the Food and Drug Administration said Thursday after completing a review of reports in its adverse events reporting system and clinical trial data.
• Regulators plan on continuing to evaluate suicide risk by pooling data from several clinical of GLP-1 drugs like Ozempic and Mounjaro, as well as analyzing data from a large database of insurance claims and patient records. The European Medicines Agency is also examining this issue, with another meeting planned for April.
• The FDA’s announcement follows a week after the release of an analysis from the National Institutes of Health and Case Western Reserve University indicating that people who take semaglutide, the active ingredient in Ozempic and weight-loss drug Wegovy, were at lower risk of suicide than people who take drugs other than GLP-1s for diabetes or obesity.

Dive Insight:

The concerns over suicide ideation — thinking about or planning suicide — emerged last year when the Icelandic drug agency reported to the EMA two cases in people taking GLP-1s. One was taking Saxenda, Novo Nordisk’s daily weight-loss shot, and the other was taking Ozempic, Novo’s weekly diabetes shot that is often used off-label for obesity. Icelandic authorities also reported one case of self-harm in a person taking Saxenda.

The FDA’s initial evaluation looked at reports in its Adverse Event Reporting System, which consist of reports of severe side effects and medication errors reported to the agency. It cautions, however, that the database is incomplete, may contain duplicate and unverified reports, and isn’t systematic enough to establish occurrence rates.

Nonetheless, the FDA concluded that “information in these reports did not demonstrate a clear relationship” between the use of GLP-1-based drugs and suicide risk. In early December, the EMA came to a similar conclusion, but said it would continue to probe the issue.

The FDA will conduct a “meta-analysis” of GLP-1 trials to further assess the risk. This type of review pools together data from different trials to determine whether the cases of suicide ideation reported in individual clinical trials, taken together, constitute a statistically significant risk.

The FDA has included warnings about suicide risk on the prescribing information for Wegovy and Zepbound, Lilly’s GLP-1-based weight-loss drug, but only because it has been reported in users of other weight-loss drugs. Suicidal thoughts and actions are not listed as adverse events reported in clinical trials for either.

Novo reported 100 billion Danish kroner, or roughly $14.7 billion, in sales from its semaglutide products through the first nine months of 2023, while Lilly reported $3 billion in sales from Mounjaro over the same period. The FDA approved Zepbound on Nov. 8.