GLP-1 drugs not linked to suicidal thoughts, EU drug regulator finds

Evan Walker
Evan Walker TheMediTary.Com |
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European drug regulators have found no significant evidence linking GLP-1 drugs like Ozempic and Wegovy to suicidal thoughts. NurPhoto/Getty Images
  • A conference of the European Medicines Agency has found no significant evidence linking GLP-1 drugs to suicidal thoughts or self-harm.
  • The agency’s risk assessment committee based its findings on two large studies of electronic records in which no association was found.
  • Many people using GLP-1 drugs for weight loss may also experience an improvement in mood as they lose weight.
  • GLP-1 medications should only be taken under the supervision of a physician and not acquired by other means.

After an extensive investigation, the European Medicines Agency (EMA) released an expansive report dispelling any possible association between the use of GLP-1 receptor agonists and suicidal thoughts or self-harm.

The organization’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded there is no statistical evidence of a link between GLP-1 drugs and suicidal ideation.

The Food and Drug Administration (FDA) reached the same conclusion in January.

GLP-1 drugs have been used to treat diabetes for about 20 years since they aid blood sugar control. In recent years, GLP-1 drugs like Ozempic and Wegovy have exploded in popularity for weight loss.

The European Medicines Agency announcement is based on two studies.

The first analyzed a large database of electronic health records. Researchers tracked the incidence of reported suicidal thoughts among people with diabetes being treated with the GLP-1 drug semaglutide or other non-GLP-1 receptor agonist drugs, as well as people being treated as overweight or obese.

A second study, conducted by the EMA, analyzed electronic health records investigating the incidence of suicidal and self-injury events in people with type 2 diabetes (T2D).

PRAC also considered clinical trials, non-clinical studies, and post-marketing surveillance data in reaching their conclusion that no warnings regarding suicidal or self-harm ideation need to be added to GLP-1 products’ information.

Mounjaro and Zepbound (tirzepatide) were not included in the studies, but both have mechanisms that are similar to semaglutide drugs.

The concerns about suicide and self-harm began with reports by the Icelandic governmental Health department in July 2023. It described three patients, two of whom had suicidal thoughts and one who engaged in self-harm.

This may seem like a small number of incidents, considering the thousands of people now taking GLP-1 drugs.

“Suicide is a serious issue and should be investigated for sure,” Angela Fitch, MD, co-founder and chief medical officer of metabolic health and primary care physician at Knownwell, not involved in these studies, told Medical News Today.

“There are also a lot of past issues with medications for obesity that make this treatment come under higher scrutiny,” Fitch added.

Mir Ali, MD, bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center, likewise not involved in these studies, noted reports of adverse events associated with drugs must be taken seriously.

“Any time somebody makes some sort of report of what they think is a potential complication, it has to be investigated,” Ali told MNT.

“Physicians must continue to monitor the mental state of their patients, as people with obesity, and those undergoing treatment for obesity, have a higher prevalence of mood disorders at baseline,” Ali said.

GLP-1 receptor drugs — or glucagon-like peptide 1 receptor agonists — release an agonist to the brain after a meal that triggers a sense of fullness.

These medications also slow the emptying of the stomach’s contents, which furthers the sense of satiety, a sensation of fullness after a meal.

Researchers and Health officials want to ensure the safety of GLP-1 drugs due to their widespread use for weight loss.

When used as directed and under the guidance of a physician, GLP-1 medications are generally considered safe. This, of course, excludes any counterfeit or fake GLP-1 medication. Serious adverse events, such as stomach paralysis, are uncommon but may occur.

People taking GLP-1 drugs eat less and lose up to 15% of their body weight in a year. While many people experience weight regain after stopping GLP-1 drugs, recent research suggests that exercising while on this medication can promote healthy weight management.

While only two medications, Wegovy and Zepbound, have been approved for weight loss, many doctors prescribe GLP-1 receptor drugs “off-label” for patients with overweight or obesity.

Among the most popular medications for such off-label use is Ozempic. Others include Rybelsus (or semaglutide), Saxenda, Trulicity, and Mounjaro, which have similar ingredients and mechanisms of action to Wegovy and Zepbound.

Despite that GLP-1 drugs are considered safe when used as intended, Fitch said our approach to this medication should be patient-dependent.

“[That’s] why comprehensive care — versus getting a medication by filling out a form on the internet — is so important,” Fitch noted.

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