EXCLUSIVE: FDA Removes Suicidal Ideation, Depression Language From Obesity GLP-1 Labels After Class-Wide Review

The FDA has formally removed suicidal ideation and depression language from the labeling of GLP-1 medications approved for obesity, closing out a nearly three year safety signal review that began in 2023.

Supplement approval letters issued in late February to Novo Nordisk and Eli Lilly confirm that subsection 5.9, Suicidal Ideation and Behavior, has been removed from the Warnings and Precautions sections of Saxenda, Wegovy, and Zepbound. References to “depression or thoughts of suicide” have also been deleted from the Medication Guides.

The move follows a July 21, 2023 Notification of Newly Identified Safety Signal in which the agency disclosed it was evaluating reports of suicidal ideation across the GLP-1 receptor agonist class. On January 13, 2026, the FDA issued supplement request letters asking sponsors to update labeling based on its evaluation. Those changes are now finalized.

The approval letters state that the January regulatory action represents the outcome of the FDA’s safety signal review.

Obesity labeling, not diabetes

The removal applies to obesity labeled GLP-1 products including Novo Nordisk’s Wegovy and Saxenda and Lilly’s Zepbound.

Importantly, the diabetes labeled versions of these medicines did not carry the same standalone suicidal ideation subsection. Ozempic, Mounjaro, and Victoza labeling has not contained equivalent warning language specific to suicidal behavior. The FDA’s action effectively brings obesity labeling in line with the broader absence of a confirmed causal psychiatric signal in diabetes indications.

What changed and what did not

The FDA’s decision reflects its conclusion that available evidence does not support maintaining a formal warning. It does not constitute a finding that psychiatric symptoms never occur in individual patients.

In the same Zepbound supplement letter, the agency added new postmarketing language regarding intestinal obstruction and severe constipation including fecal impaction under gastrointestinal adverse reactions, underscoring that class surveillance remains active.

The signal on mood appears closed. GI monitoring continues.

The neuroscience question is not going away

Even as regulators remove psychiatric warning language, pharmaceutical development is moving in the opposite direction.

Lilly’s next generation dual agonist brenipatide, which builds on GLP and GIP mechanisms, is being studied not only in obesity but also in populations with alcohol use disorder, bipolar disorder, and opioid use disorder.

That development strategy is not accidental.

Sponsors are increasingly positioning incretin based therapies as modulators of reward circuitry, impulsivity, and compulsive behavior. The hypothesis is that metabolic and neurobehavioral pathways are intertwined, particularly through central appetite and dopaminergic systems.

In other words, pharma clearly believes this drug class has meaningful neurological effects.

The FDA’s removal of suicidal ideation language does not contradict that. It simply means that based on available data, the agency did not find evidence of a consistent or causal increase in suicidal behavior across treated populations.

Neurologically active does not automatically mean psychiatrically dangerous. But it does mean biologically consequential.

The community reality

Within the obesity community, anecdotal reports of anxiety, emotional flattening, and mood shifts persist. While these anecdotes seem to contradict this move, anecdotal reports do not establish causation and are inherently subject to bias and confounding. Still, I believe they are common enough to remain part of the lived conversation.

During periods of higher dose therapy, I experienced escalating panic and anxiety symptoms that resolved after discontinuation. That experience does not establish causation. It does underscore that individual neurobiological responses can vary, particularly with sustained exposure to higher doses.

Regulators are tasked with making population level determinations. Patients experience treatment at the individual level. We will continue to follow emerging data and patient reports, and discuss them responsibly at On The Pen.

Market implications

From a commercial standpoint, the label change removes a reputational headwind that had become a recurring talking point for critics. For Lilly and Novo, it simplifies obesity messaging at a time when competition is intensifying and next generation multi agonists are advancing rapidly.

It also underscores the FDA’s willingness to publicly close safety reviews when data do not support maintaining cautionary language.

The psychiatric question, however, may not disappear entirely. As triple agonists and higher potency agents move through development, regulators will continue to scrutinize central nervous system effects.

For now, the agency’s position is clear: suicidal ideation and depression no longer warrant inclusion in obesity GLP-1 labeling.

The broader neuroscience story, meanwhile, is only just beginning.

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