Usually, when new medicines have been on the market for a time, warnings tend to accumulate in the prescription labeling. So it is a bit unusual to see the FDA move to remove a warning. But recently, that’s exactly what happened with semaglutide and tirzepatide. FDA is making a course correction on warnings about suicidal thoughts on the drug labeling for both Wegovy and Zepbound. The agency also called for the change in labeling for an older GLP-1, Saxenda (liraglutide).

FDA spelled out their request in a formal notice:

“FDA is requesting that drug application holders remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that currently include such language. The affected products are Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide). This action follows a comprehensive FDA review that found no increased risk of SI/B associated with the use of GLP-1 RA medications.”

In sum, the agency looked closely and found no evidence that reports of suicidal ideation and depression could be an effect of these drugs. Correctly, it seems, the agency is paying attention to the hazards of giving false warnings.

Similar Findings in Obesity

Coinciding with this FDA action, Thomas Wadden and colleagues published a peer-reviewed analysis of the psychiatric safety of tirzepatide in Obesity. In a post-hoc analysis of 4,056 patients with obesity who received tirzepatide, they concluded:

“Treatment with once weekly tirzepatide was not associated with an increased risk of developing symptoms of clinically significant depression in people with overweight or obesity, with or without T2D, and without known major psychopathology.”

Regardless, though, monitoring and supporting the mental health of persons living with obesity remains very important. Wadden et al explain:

“Given the high risk of depression and anxiety in people with obesity—particularly with BMI ≥ 40 kg/m2—we support ongoing monitoring of mental health in all such individuals, whether or not engaged in weight management, so that they may receive psychiatric care as needed.”

The relationship between obesity and mental health is complex. Mental health issues can contribute to obesity. And the reverse is also true. So good mental health care is essential for good obesity care.

Click here for the study by Wadden et al, here and here for the details of FDA’s recent action. For additional reporting, click here. Finally, you can find excellent perspective on the importance of mental health care in obesity, here.

Depression, Selbstporträt. Painting by Karl Wiener / Wikimedia Commons