FDA Finds No Evidence Linking Wegovy, Ozempic to Suicidal Behaviors
12 Jan 2024
Clinical ResultDrug Approval
FRIDAY, Jan. 12, 2024 -- In a preliminary review, the U.S. Food and Drug Administration says it has found no evidence drugs like Wegovy and Ozempic cause suicidal thoughts or actions.
Still, the agency noted officials cannot rule out that "a small risk may exist," and it will continue to look into similar reports involving these glucagon-like peptide-1 receptor agonists.
The FDA review comes on the heels of a study funded by the National Institutes of Health that showed people taking semaglutide had a lower risk for suicidal thoughts than those taking other drugs to treat obesity and diabetes. In that study, researchers tracked more than 240,000 obese people and more than 1.5 million people with type 2 diabetes. They looked at the risk for suicidal ideation within six months of starting the medicines, as well as at later times.
At six months, the researchers found that among people taking the drug for weight loss, semaglutide was linked to a 73 percent lower risk for first-time suicidal ideation and a 56 percent lower risk for recurrent suicidal ideation. The drugs to which semaglutide was compared included bupropion, naltrexone, orlistat, topiramate, and phentermine. For people with type 2 diabetes, the reductions were 64 and 49 percent, respectively. Here, the drugs to which semaglutide was compared included insulin, metformin, dipeptidyl peptidase 4 inhibitorsdipeptidyl peptidase 4 inhibitors, and sodium-glucose cotransporter 2 inhibitorssodium-glucose cotransporter 2 inhibitors.
Even though semaglutide was associated with a lower risk for suicidal ideation in the NIH study, the investigators wrote in a research briefing that the data "do not yet justify off-label treatment" for suicidal thoughts.
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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
Posted January 2024
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