- A new large US-based study found no link between semaglutide and suicidal ideation.
- The findings indicate a slightly higher risk of suicidal ideation in people taking other weight loss or diabetes medications.
- The FDA is evaluating the safety of GLP-1 drugs such as Ozempic, Wigovy, and Munjaro after anecdotes of suicidal thoughts and hair loss.
- The risk of suicidal ideation is not currently listed as a potential side effect of GLP-1 drugs prescribed for weight loss or 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” following the FDA Adverse Event Reporting System (FAERS) report. report Investigation of side effects in people using GLP-1 drugs such as Ozempic, Mounjaro, Zepbound, and Wegovy.
However, a large new study funded by the National Institutes of Health (NIH) suggests that semaglutide, the active ingredient in Ozempic and Wigovy, is not associated with suicidal ideation. It turned out that they were not related.
The analysis was published in an online journal on January 5th. natural medicineshow that semaglutide is actually associated with a 49-73% lower risk of first-time suicidal ideation compared to other drugs prescribed for obesity or type 2 diabetes.
This study is the first to investigate a potential association between suicidal ideation and semaglutide.
Several countries outside the United States are investigating suicidal ideation as a side effect of GLP-1 drugs. In August 2023, the regulator Canada, Europeand the England evaluated whether suicidal ideation was caused by GLP-1 medication or was associated with underlying medical conditions.
The report said the FDA “identified potential safety issues” with these drugs but did not demonstrate a “causal relationship between the drugs and the described risks.” FAERS website.
The FDA recommends that people using GLP-1 drugs for weight loss or diabetes who are concerned about side effects consult their health care team.
In a recent NIH-funded study, a team of scientists from Case Western Reserve University and the National Institute on Drug Abuse (NIDA) examined the health records of 240,618 people diagnosed with overweight or obesity in the United States. The average age of the subjects was 50 years, and 73% were female.
Patients were prescribed semaglutide or another weight loss drug from June 2021 to December 2022. Within the group, 232,771 people had no history of suicidal ideation, compared to 7,847 who had.
Researchers replicated their findings in a sample of 1.6 million people diagnosed with type 2 diabetes (T2D), with an average age of 58 and 49% women. These patients were prescribed semaglutide or another drug to manage their condition between December 2017 and May 2021.
Of this group, 1.6 million had no history of suicidal ideation, but nearly 17,000 had.
The researchers noted that each study population, the semaglutide group and the type 2 diabetes group, were similarly matched in demographics, medical history, lifestyle, and history of mental health conditions, including suicidal thoughts and behaviors.
They tracked participants’ medical histories for six months after being prescribed the drug and found that those who took semaglutide for weight loss had a 0.1% risk of first-time suicidal ideation, and if they had a history of recurrent suicide. The risk of contemplation was found to be 7%. .
The risk in the semaglutide group was slightly lower than that in those prescribed other weight-loss drugs, at 0.4% and 14%, respectively.
This finding challenges previous anecdotal claims that semaglutide causes suicidal ideation.
Dr. Michael Russoa board-certified bariatric surgeon at Memorial Care Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, Calif., told Healthline that the semaglutide group had a higher risk of suicidal ideation than those taking other weight loss or diabetes medications. He told Healthline he wasn’t surprised by the low numbers.
“It’s a well-known fact that many of these other drugs are associated with increased suicidal ideation, which is one of the risks of starting to use these drugs, especially the more psychiatric drugs,” he said. said.
“The truth is that patient populations who carry excess weight have high rates of anxiety, depression, and trauma. It is therefore no surprise that they are at risk for suicidal ideation. No, but that doesn’t mean the drug is unsafe.”
The FDA lists several GLP-1 drugs under review for safety. its websiteOzempic and Wegovy (semaglutide), Mounjaro and Zepbound (tirzepatide).
Suicidal thoughts are not currently listed as a potential side effect of Ozempic and Wigovy, according to FDA drug labels and EU product information. Novo’s Nordisk, which manufactures Ozempic, said No reports of suicidal ideation were found during the clinical trial.
However, in addition to suicidal thoughts, other adverse events have been reported with GLP-1 drugs, such as hair loss (alopecia) and accidentally inhaling food or liquids (aspiration).
GLP-1 drugs have also been associated with gastrointestinal problems, the most serious of which include intestinal obstruction and gastroparesis, but these side effects are rare and are not currently listed on drug labels. I am.
However, not all GLP-1 drugs are associated with all three adverse events. For example, Zepbound is not listed as a possible cause for hair loss or aspiration, but for suicidal thoughts.
The FDA may require label changes for GLP-1 drugs if regulators determine further action is necessary. The agency is also considering a risk assessment and mitigation strategy program to ensure that the potential risks of medicines do not outweigh the benefits.
Russo said some of the reported adverse events, such as suicidal thoughts, may eventually be added to drug labels.
“I think they’re going to make the mistake of being cautious about labeling,” he says.
“Especially because these drugs are so widely used these days, the labels could add more possible complications. “If we start to see potential events, they will need to be looked at and will likely be added to the labeling,” Russo added, reiterating that this does not mean infection. Drugs are not safe.
“This means that there can be a number of challenges when taking these drugs, and we just need to be aware of that,” he said, adding that he regularly advises patients on GLPs. -1 pointed out that he was prescribing drugs.
Dr. Jody PepinMillions of people are taking these drugs, and the more people take them, the more likely these associations will be, said Roberts, director of the Clinical Pharmacy Program at Harbor Health and assistant professor of pharmacy at the University of Texas at Austin. It was explained that there is a possibility that this may be more likely to occur.
“To the extent that reported suicidal ideation can be related to GLP-1, there needs to be ample evidence of causation, not just correlation,” she told Healthline in August. Told.
If you experience any of the side effects listed with any GLP-1 medication you are taking, it is best to tell your doctor right away. Depending on the severity of your symptoms, you can discuss whether to continue or stop your medication.
“Healthcare providers can look at an individual’s health history and comorbidities to determine whether it is wise to continue the medication,” Pepin said. “We also need to do a risk-benefit analysis to improve this situation.”
“The number of suicidal thoughts is relatively small compared to the number of prescriptions written for these drugs. People who take these drugs have no comorbidities or He has underlying health conditions,” Pepin added.
Examples include pre-existing mental health conditions, such as depression, or comorbidities, such as heart disease. related Pepin said he suffers from depression.
“These reactions may have little or nothing to do with the medication you’re taking,” she noted.
Although a causal relationship between semaglutide and suicidal thoughts has not been established, if you have suicidal thoughts you should seek help immediately.
Dr. Stephen Batash, FACG, a gastroenterologist at New York University Medical Center, Lenox Hill Hospital, and NewYork-Presbyterian Hospital, offers endoscopic weight loss procedures or nonsurgical weight loss procedures. Although he has not encountered anyone in his own practice who has experienced suicidal thoughts after taking GLP-1 drugs, he says it is important for doctors who prescribe these drugs to conduct mental health screenings. He said that.
“Patients who have mental health issues or have experienced suicidal thoughts should be highly alerted to potential side effects,” he told Healthline in a previous interview.