Are GLP-1 agonists safe? FDA finds no evidence popular weight loss medications cause suicidal thoughts or actions
The U.S. Food and Drug Administration (FDA) has found no evidence that the use of GLP-1 receptor agonists such as semaglutide cause suicidal thoughts or actions. The agency launched a full investigation into this issue after receiving multiple reports that suggested such a relationship was possible.
While these drugs were originally developed to treat diabetes, they have been used more and more in the United States to help obese and overweight patients lose weight.
“Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions,” the FDA said in a new Drug Safety Communication dated Thursday, Jan. 11. “Over the last several months, we have conducted detailed reviews of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System. Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 receptor agonists.”
The agency emphasized that it would continue looking into this issue, because it could not “definitively rule out that a small risk may exist.”
Additional details from the FDA about GLP-1 receptor agonists
The FDA emphasized in its assessment that patients prescribed GLP-1 drugs should not abruptly stop taking them without consulting a professional.
“Tell your healthcare professional if you experience new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior,” the FDA wrote. “Call or text 988 or go to the website at https://988lifeline.org/, which provides free support for people in distress 24 hours a day, seven days a week.”
The agency also indicated that healthcare providers should consult all applicable prescribing information to ensure they are only offered to eligible patients.
Recent research into the potential link between GLP-1 receptor agonists and suicidal ideation
A new study published Friday, Jan. 5, in Nature Medicine seems to back up the FDA’s preliminary findings.[1]
Rong Xu, PhD, a professor of biomedical informatics and director of the Center for AI in Drug Discovery at Case Western Reserve University, and colleagues examined data from more than 240,000 overweight or obese patients prescribed either semaglutide or non-GLP-1 receptor agonist anti-obesity medications. The group’s findings did not support the possibility that these drugs could cause suicidal ideation.
Access the full study here for more information.
Semaglutide, other GLP-1 receptor agonists continue taking the world by storm
GLP-1 receptor agonists are now being used to treat obese and overweight patients throughout the United States. Recent evidence even suggests semaglutide, which Novo Nordisk sells under the brand names Wegovy and Ozempic, can help certain patients reduce their risk of cardiovascular events.
These drugs work by mimicking a hormone in the intestines, stimulating the release of insulin and reduce blood glucose after the patient has eaten a meal. GLP-1 receptor agonists also slow down food as it travels down the digestive tract, yet another way they can make someone “feel” full for longer periods of time.
The increased utilization of GLP-1 receptor agonists was arguably the biggest story in healthcare in 2023. Science, a popular journal published by the American Association for the Advancement of Science, even named the ongoing trend its 2023 Breakthrough of the Year.
“These new therapies are reshaping not only how obesity is treated, but how it’s understood—as a chronic illness with roots in biology, not a simple failure of willpower,” author Jennifer Couzin-Frankel said at the time.