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GLP-1 drugs are under federal investigation following reports of adverse events, but a new study shows no link between drugs containing semaglutide and suicidal ideation. CreativaImages/Getty Images
  • A large new U.S.-based study found no link between semaglutide and suicidal ideation.
  • The findings show the risk of suicidal thoughts is slightly higher among individuals taking other weight loss and diabetes medications.
  • The FDA is evaluating GLP-1 drugs like Ozempic, Wegovy, and Mounjaro for safety following anecdotal reports of suicidal ideation and hair loss.
  • The risk of suicidal ideation is not currently listed as a potential side effect of GLP-1 drugs, which are prescribed for weight loss and diabetes.

GLP-1 drugs prescribed for weight loss and diabetes are currently under federal investigation.

The Food and Drug Administration (FDA) is “evaluating the need for regulatory action” after the FDA Adverse Event Reporting System (FAERS) received reports of side effects in people using GLP-1 medications like Ozempic, Mounjaro, Zepbound, and Wegovy.

However, a large new study funded by the National Institutes of Health (NIH) found that semaglutide, the active ingredient in Ozempic and Wegovy, is not linked to suicidal thoughts, despite anecdotal claims suggesting otherwise.

The analysis, published online on January 5 in the journal Nature Medicine, shows that semaglutide is actually associated with a 49–73% lower risk of first-time suicidal ideation compared to other medications prescribed for obesity or type 2 diabetes.

The research is the first to examine a potential association between suicidal ideation and semaglutide.

Multiple countries outside of the United States have been investigating suicidal ideation as a side effect of GLP-1 medications. In August 2023, regulatory agencies in Canada, Europe, and the United Kingdom assessed whether suicidal ideation may be caused by GLP-1 medication or is associated with underlying conditions.

Although the “FDA has identified a potential safety issue” with these medications, the agency says it does not indicate “a causal relationship between the drug and the listed risk,” according to the FAERS website.

The FDA recommends people using GLP-1 drugs for weight loss or diabetes who are concerned about side effects should talk with their healthcare team.

For the recent NIH-funded study, a team of scientists at Case Western Reserve University and the National Institute on Drug Abuse (NIDA) looked at health records in the United States from 240,618 people who were diagnosed with overweight or obesity. The average age of subjects was 50, and 73% were female.

Patients were prescribed semaglutide or a different weight-loss medication between June 2021 and December 2022. Within the group, 232,771 people had no prior history of suicidal ideation compared to 7,847 people who did.

The researchers replicated the findings in 1.6 million people diagnosed with type 2 diabetes (T2D) who had an average age of 58 and were 49% female. These patients were prescribed semaglutide or another medication to manage their condition between December 2017 and May 2021.

Among this group, 1.6 million people had no prior history of suicidal ideation whereas nearly 17,000 people did.

The researchers noted that each study population, the semaglutide group and the type 2 diabetes group had similarly matched demographics, medical histories, lifestyles, and histories of mental health conditions, including suicidal ideation and behavior.

They followed subjects’ medical histories for 6 months after they were prescribed medication and found that people who took semaglutide for weight loss had a 0.1% risk of first-time suicidal ideation and a 7% risk of recurrent suicidal ideation if they had a prior history.

The risk among the semaglutide group was slightly lower than that of those prescribed other weight loss medications — 0.4% and 14%, respectively.

The findings challenge prior anecdotal claims about semaglutide causing suicidal thoughts.

Dr. Michael Russo, board certified bariatric surgeon at MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, told Healthline he was not surprised the semaglutide group had a lower risk of suicidal ideation than the group taking other weight loss and diabetes medications.

“It’s a well-known fact that many of these other drugs carry with them increased suicidal ideation as one of the risks of starting these drugs, especially the drugs that are more psychiatric type drugs,” he said.

“The truth is that the patient population that carries excess weight has a high rate of anxiety, depression, and trauma. So, it’s not surprising that they carry this risk of suicidal ideation — but it doesn’t mean that the drugs are unsafe.”

The FDA lists multiple GLP-1 drugs under review for safety on its website, including Ozempic and Wegovy (semaglutide), and Mounjaro and Zepbound (tirzepatide).

Suicidal thoughts are not currently listed as a potential side effect of Ozempic and Wegovy, according to the FDA’s drug label and the EU product information. Novo Nordisk, the manufacturer of Ozempic, has stated that no reports of suicidal thoughts were found during its clinical trials.

But in addition to suicidal ideation, other adverse events from GLP-1 drugs have been reported, including hair loss (alopecia) and accidentally breathing in food or liquid (aspiration).

GLP-1 drugs have also been linked to gastrointestinal issues, the most severe of which include bowel obstruction and stomach paralysis, but these side effects are rare and are currently listed on the drugs’ labels.

However, not all GLP-1 drugs are linked to all three adverse events. For example, Zepbound is not listed as a possible cause of hair loss or aspiration but is for suicidal ideation.

The FDA may require label changes on GLP-1 drugs if regulators determine that further action is needed. The agency is also considering a Risk Evaluation and Mitigation Strategy program that would confirm the drugs’ potential risks do not outweigh the benefits.

Russo that some of the adverse events reported, including suicidal ideation, may eventually be added to the medication labels.

“I think that they’re going to err on the side of caution with regard to labeling,” he said.

“There’s going to likely be additional possible complications added to the label, especially because these drugs are so widely used these days. The patient population is very large, so when you start seeing these types of possible complications or adverse events, they need to be looked at, and they’ll likely be added to labeling,” Russo added, reiterating that it does not mean that the drugs are unsafe.

“It just means there’s a spectrum of possible challenges in taking these drugs that you just need to acknowledge,” he said, noting that he prescribes GLP-1 drugs to his patients routinely.

Dr. Jodie Pepin, clinical pharmacy program director at Harbor Health and an assistant professor of pharmacy at the University of Texas in Austin, explained that millions of people have taken these medications, and the more people who take them, the more likely these associations may occur.

“As far as the reported suicidal thoughts possibly related to the GLP-1s, there will have to be an abundance of evidence that proves causation, not just correlation,” she told Healthline in August.

If you experience any side effects listed on the GLP-1 medication you’re taking, it’s best to tell your doctor immediately. You may discuss whether to continue or discontinue the drug, depending on the severity of your symptoms.

“The provider can look at the individual’s health history and comorbidities to determine if it is prudent to continue the medication or not,” Pepin said. “A risk-benefit analysis should also be done to aid in this situation.”

“The numbers of suicidal thoughts are relatively small compared to the number of prescriptions written for these medications. The population who takes these medications have comorbidities or underlying conditions that may influence their response to drugs,” Pepin added.

Examples include preexisting mental health conditions like depression or comorbidities like heart disease, which can often be associated with depression, Pepin said.

“These responses may have little or nothing to do with the medication they are taking,” she noted.

While no causal link between semaglutide and suicidal ideation has been established, if you’re having suicidal thoughts, you should seek help right away.

Dr. Steven Batash, FACG, a gastroenterologist with NYU Medical Center, Lenox Hill Hospital, and NewYork-Presbyterian Hospital, provides endoscopic weight loss procedures or nonsurgical weight loss. He said that in his practice, he hasn’t come across anyone experiencing suicidal thoughts after taking a GLP-1 drug, but noted it’s important for any physician prescribing these medications to do a mental health screening.

“A patient who has a history of having mental health issues or experience suicidal thoughts should be strongly cautioned about potential side effects,” he told Healthline in an earlier interview.

Help is out there

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

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