BioPharma, Pharma

FDA’s Preliminary Review of GLP-1 Meds Finds No Tie to Suicidal Thoughts, Actions

The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing.

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An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions.

The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified.

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The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced by other factors, the FDA said. Consequently, the agency said it determined the reports did not demonstrate a clear relationship with GLP-1 drugs. This finding is preliminary.

“However, because of the small number of suicidal thoughts or actions observed in both people using [GLP-1 receptor agonists] 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 agency said in the drug safety communication.

The class of GLP-1 drugs are engineered versions of peptides that bind to the GLP receptor and activate it, stimulating the secretion of the blood sugar-regulating hormone insulin. Drugs in this class were initially approved as treatments for type 2 diabetes. But these medications also suppress appetite, leading to weight loss. Novo Nordisk’s Wegovy and newly approved Eli Lilly drug Mounjaro are GLP-1 agonists that have won FDA approvals for weight management.

The most common side effects reported for GLP-1 drugs are gastrointestinal problems, such as diarrhea, nausea, stomach discomfort, and constipation. Europe was first to explore the potential association of GLP-1 drugs and suicide. Last July, the European Medicines Agency announced that its Pharmacovigilance Risk Assessment Committee (PRAC) was reviewing the risk of suicidal thoughts following reports by Icelandic health authorities. At its November meeting, the PRAC requested that makers of GLP-1 medicines provide supplementary information.

There’s precedent for weight loss medications being associated with suicidal thoughts and actions. Sanofi-Aventis’s rimonabant, brand name Acomplia, won EMA approval as an obesity drug in 2006. The small molecule drug was designed to target and block cannabinoid receptor type 1. In addition to its a role in mood and anxiety, this receptor also plays a role in appetite. However, the targeting of the receptor for appetite may have also triggered psychiatric effects. Those concerns prompted a regulatory review that concluded Acomplia’s benefits no longer outweigh its risks.

Acomplia never reached the U.S. market. Sanofi-Aventis withdrew its FDA application after an advisory committee in 2007 voted against recommending approval.

Photo: Sarah Silbiger, Getty Images