FDA orders Eli Lilly and Novo Nordisk to remove suicide warnings from Wegovy and Zepbound

The FDA has requested the removal of suicide warnings from the labels of Wegovy and Zepbound.  

The warnings were added when the drugs were first approved for weight management in 2021 and 2023 after patients taking older weight loss treatments reported depression and suicidal ideation.

But in an action on Tuesday, regulators said an extensive review of clinical and real-world data showed no increased suicide risk among people using the drugs.

Ozempic and Mounjaro, the sister medications approved for type 2 diabetes rather than weight management, do not have suicide warnings on their labels, with the FDA saying the update will bring all GLP-1 drugs into line. 

The agency said: ‘Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 medications.’

Suicide risk was a major safety concern around weight loss drugs after the FDA received hundreds of reports from patients who said they started experiencing suicidal thoughts or despair while taking the drugs, despite, in some cases, having no prior history of mental health problems.

But regulators said their major analysis, which reviewed 91 studies involving more than 100,000 people, found no link between the medications and suicide and that there was a ‘small number’ of cases in individual trials.

The requested label change also applies to Saxenda, an older GLP-1 by Novo Nordisk approved for weight management in December 2014.

A spokesperson for Novo Nordisk, which manufactures Wegovy and Saxenda, said the company was happy to see the FDA’s recommendation.

A representative for Eli Lilly, which manufactures Zepbound, said the company appreciated the FDA’s ‘careful consideration of this important safety issue.’

They added that Lilly would ‘continue to work with the FDA on next steps to ensure that appropriate safety information is available to prescribers.’

Previously, under the section on possible side effects, Wegovy’s label warned: ‘Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts or feelings.

‘Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.’

The same warning was written on the label for Zepbound.

For Saxenda, the label read: ‘Patients treated with Saxenda should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

‘Discontinue Saxenda in patients who experience suicidal thoughts or behaviors. Avoid Saxenda in patients with a history of suicidal attempts or active suicidal ideation.’ 

The FDA said it began an investigation into suicide risks and weight loss drugs in 2023 amid reports of mood changes from patients.

In a meta-analysis, the agency compared the risk of suicidal ideation or behavior among people taking weight loss drugs to those on a placebo. 

It analyzed data from 91 trials, including 100,000 people, of which 60,000 were on weight loss drugs, but said it found there was no increased risk for suicidal ideation or behavior among those taking weight loss drugs compared to those who were not.

In a second study, the FDA analyzed healthcare claims for intentional self-harm among new users of weight loss drugs and new users of sodium-glucose cotransporter 2 (SGLT2) inhibitors, a diabetes medication that prompts the kidneys to filter excess sugar from the blood, which has also been linked to weight loss.

Overall, the study included 2.2 million people, of whom 1.1 million used a weight loss drug. Patients took the medication between October 2015 and September 2023.

The data showed, according to the FDA, that there was no increased risk of intentional self-harm among new users of weight loss drugs compared to those taking OTHER? diabetes medications. 

The agency said: ‘Consistent with these findings, the FDA is requesting that application holders [drug companies] remove information regarding the risk of suicidal ideation and behavior from the labeling of weight loss medications that currently include such language.’

Concerns over a potential link between weight loss drugs and suicide were elevated in 2023 after a former US health chief Dr Erick Turner said the link between the two was becoming ‘more credible.’

The FDA has received hundreds of reports of suicidal thoughts and depression from patients on weight loss medications since 2010.

It has also received at least 36 reports of deaths among people on the drugs ‘by suicide or suspected suicide.’

These reports come from the FDA’s Adverse Event Reporting System (FAERS). Reports in this system are unverified because anyone can submit a report. The system is supposed to act like a crude early warning system for potential drug side effects.  

Among patients to suggest that weight loss drugs caused depression was mother-of-four Dawn Heidlebaugh, from Ohio, who said in 2023 that taking Ozempic left her feeling suicidal. 

Heidlebaugh, who works in real estate, revealed she started taking the drug every Sunday and that by Tuesday she would feel lethargic, depressed and at times suicidal, believing her family would be better without her.

The symptoms would persist for a few days, she said, and then return shortly after her next injection. They only didn’t appear when she skipped a dose.

Heidleberg, who had no history of depression, told Reuters: ‘I knew it was the drug.’

Experts have previously suggested there may be a potential link saying that the drugs prompt patients to eat less, which may be a coping mechanism for many.  

An estimated one in seven Americans, equivalent to 20 million people, have now used a weight loss drug, although it is not clear what proportion used Wegovy, Zepbound or Saxenda.