There is no evidence linking diabetes and weight loss drugs like Ozempic and Wegovy to an increase in suicidal thoughts, the European Union’s drug regulator said Friday, the latest findings casting doubt on a link after a probe by U.S. regulators said a “small risk” couldn’t be ruled out.
The Food and Drug Administration said it couldn’t rule out that “a small risk may exist.”
The European Medicines Agency’s safety committee concluded evidence between two studies doesn’t indicate a link between a category of drugs that includes Ozempic, Wegovy and Rybelsus—known as glucagon-like peptide-1 (GLP-1) receptor agonists—and thoughts about suicide or self-injury, the agency said.
The agency reviewed a study that investigated the rate of suicidal thoughts in patients with type 2 diabetes who were treated with semaglutide, the generic name for Ozempic, Wegovy and Rybelsus.
Another similar study—carried out by the EMA—was analyzed in addition to other clinical trials, non-clinical studies and post-marketing surveillance data.
No updates to product information for any GLP-1 drug are needed, according to the agency, which noted manufacturers of the drugs—including Eli Lilly, Novo Nordisk and AstraZeneca—are required to continue monitoring associated events closely.
GLP-1 drugs like Wegovy and Ozempic have surged in popularity for both diabetes and weight loss in recent years—while Ozempic is not approved for weight loss, some doctors prescribe it off-label for that purpose. The European Union’s nine-month probe into GLP-1 drugs followed Iceland’s health regulator flagging three cases of patients thinking about suicide last July. About 150 other reports of possible cases of suicidal thoughts and self-injury were also retrieved by health officials, the agency said. The FDA said earlier this year a preliminary evaluation into GLP-1 drugs has “not found evidence” linking them to suicidal thoughts or actions. The agency noted it could not “definitively rule out that a small risk may exist” because a “small number” of suicidal thoughts or actions were observed among people using the drugs. Another study published in Nature Medicine determined there was no evidence the drug semaglutide increased the risk of suicidal thoughts. Researchers said after six months of treatment, patients using semaglutide had a lower risk of suicidal ideation.
The EMA said last year that available evidence does not support a link between GLP-1 drugs and thyroid cancers, after an earlier study indicated an increased risk. Earlier this week, one of the largest studies into the possible link—including the health data for more than 145,000 people—determined GLP-1 medications did not cause a substantial increase in the risk of developing thyroid cancer. Novo Nordisk, which manufactures Ozempic, Wegovy, Saxenda and Victoza, lists thyroid cancer as a potential side effect of each medicine.
FDA Finds No Preliminary Link Between Ozempic And Suicidal Thoughts (Forbes)
GLP-1s Like Ozempic, Wegovy Don’t Substantially Increase Thyroid Cancer Risk (Forbes)
No Proven Link Between Weight Loss Drugs And Thyroid Cancer, EU Says (Forbes)