The European Union’s drug regulator is probing a possible link between diabetes drugs, popular for weight loss, and suicidal thoughts.
The European Medicines Agency (EMA) is assessing 150 reports of possible cases of self-injury among people taking a class of medications called GLP-1 agonists, which play a role in regulating metabolism and hunger.
The EMA said the Icelandic Medicines Agency initiated the review due to reports of suicidal thoughts and self-injury in individuals using liraglutide and semaglutide drugs for weight loss. Semaglutide belongs to the glucagon-like peptide-1 (GLP-1) receptor agonists sold under the brand name Ozempic. In 2014, the U.S. Food and Drug Administration (FDA) approved semaglutide for weight loss among obese or overweight people with at least one weight-related condition, such as high blood pressure, Type 2 diabetes, or high cholesterol. For them, semaglutide is sold under the name Wegovy, which is a higher-dose version of Ozempic. “It’s important to note that the EMA review is only for GLP-1s indicated for obesity,” Ambre James-Brown, global vice president of Media & Digital Global Communication at Novo Nordisk, told The Epoch Times. “The EMA review does not include diabetes medications, meaning this is not an investigation of Ozempic.” While the investigation is ongoing, the EMA has
advised health care professionals to monitor patients taking this class of drugs for signs of suicidal thoughts or behavior. Your Health Matters Suicidal Behavior Linked to These Meds Has Been Noted Before GLP-1 agonists were introduced to the market in 2005. The FDA approved (pdf) Novo Nordisk’s GLP-1 agonist liraglutide (brand name Victoza) in 2010 to treat diabetes, and the company’s drug Ozempic was FDA-approved for diabetes treatment in 2017. A 2020 clinical review (pdf) by the FDA did caution about a potential association between liraglutide and suicidal thoughts in adolescents. According to the review, suicidal behavior was observed in both a placebo group and the group receiving liraglutide. The agency found no significant imbalance of psychiatric events overall but noted that obese adolescents may
be at a higher risk for suicidality and depression. The FDA concluded that in a population of adolescents with significant obesity, the benefits of the efficacy of liraglutide still “outweigh the potential risks.” Ms. James-Brown said that the safety data previously collected from large clinical trial programs and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.
Still a Good Option for Some Patients All medications may have side effects, said Dr. John Angstadt, director of bariatric surgery at Northwell Staten Island University Hospital in New York. There are cases where GLP-1 drugs, such as Ozempic (semaglutide), may be the healthiest course of action for patients living with obesity, he added. “Patients who suffer from severe obesity and related health conditions such as diabetes, high blood pressure, or heart disease will experience significant medical benefits from weight loss,” Dr. Angstadt said. Research shows that a
weight loss of 5 to 10 percent of body weight can positively impact these medical conditions. This amount can be “easily accomplished” using this class of drugs, he added. While psychological side effects are less common than digestive issues such as nausea, vomiting, and diarrhea, Dr. Angstadt clarified that they are neither very rare. “The American instructions included with Saxenda (liraglutide) tell users that before considering using the drug, they should inform their doctor if they have a history of depression or suicidal thoughts or any other psychological problem,” he added. Saxenda and Victoza both contain liraglutide, but Victoza is approved for diabetes, and Saxenda is approved for weight loss. Additionally, Saxenda’s label (pdf) lists depression or thoughts of suicide as a possible side effect and recommends regular monitoring by health care providers. “It is important that any changes in physical symptoms or feelings of depression should be immediately reported to your health care provider,” Dr. Angstadt said.
Not the First Diet-Drug Controversy Another diet drug, rimonabant, also has a history of concerns. Rimonabant was approved for use in Europe in 2006, and studies showed that it not only led to weight loss but also improved cholesterol and blood sugar levels in diabetics. It acted as a selective central cannabinoid (CB1) receptor antagonist and functioned solely as an appetite suppressant. In contrast, GLP-1 agonists not only act as appetite suppressants but also directly impact insulin metabolism for diabetes treatment and h
unger reduction. Never approved in the United States, it was sold under brand names that included Acomplia, Riobant, and Slimona. In 2008, the EMA withdrew its approval for the drug (pdf) after discovering that obese or overweight patients taking Acomplia had approximately twice the risk of developing psychiatric disorders compared to those on a placebo. Currently, about 74 percent of the U.S. population is obese or overweight, and researchers continue to explore potential drugs to address this issue. But drugs are not a cure-all, and maintaining a healthy weight requires a lot of effort, with lifestyle changes being key for long-term success. “Medications can provide a jump-start to weight loss, but sustainable weight management requires long-term lifestyle changes,” Dr. Angstadt sid, recommending building healthy habits around diet, exercise, stress management, and adequate sleep.