Wegovy, Ozempic Seem to Be Less Dangerous Than Feared, FDA Says

A popular class of weight loss and diabetes drugs looks to be safer than feared, at least so far. This week, the Food and Drug Administration announced it hasn’t found compelling evidence that Wegovy, Ozempic, and other GLP-1 drugs can cause suicidal thoughts or behaviors—a concern that first emerged last year. The FDA hasn’t definitively ruled out a possible connection just yet, however, and it is still conducting further investigation into the matter.

In summer 2023, health regulators in Iceland, the UK, and the European Union announced that they had received case reports tying the use of GLP-1 drugs to suicide ideation, and that they would conduct a review of these medications in response. In early January, the FDA updated its public list of potential new safety risks associated with approved drugs to include a possible link between GLP-1 use and increased ideation as well (along with two other potential side effects, hair loss and food aspiration).

But the FDA has been conducting its own review of the available data for months, according to the agency. This review has involved poring through data from large-scale clinical trials of these drugs, as well as post-market reports submitted to the FDA Adverse Event Reporting System (FAERS). And for the time being, the FDA is not seeing anything alarming.

“FDA’s preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions,” the agency said in a statement released Thursday.

GLP-1 drugs have been used for decades to help people manage their type 2 diabetes. More recently, the drugs semaglutide (sold under the brands Ozempic and Wegovy) and tirzepatide (Mounjaro and Zepbound) have adapted into the next generation of obesity medications—medications that have been far more effective at helping people lose weight than diet and exercise alone, as well as compared to older obesity drugs. The latest drug, Eli Lilly’s Zepbound, was approved by the FDA for obesity this past fall.

This drug class is known to cause common gastrointestinal side effects like nausea, vomiting, and constipation, which may wane over time. And since the drugs’ debut, some patients and doctors have reported likely rare but serious complications possibly tied to their use, such as gastroparesis (stomach paralysis), pancreatitis, and ileus (intestinal blockage), among others. Last September, the FDA found these reports credible enough to update its labeling of Wegovy and Ozempic to mention the possible risk of ileus, though it did not confirm it as an established side effect.

The FDA notes that the risk of suicide is already discussed on the current labeling of GLP-1 drugs, though this is largely based on evidence tying older weight loss drugs to suicide ideation. And it’s still possible that the agency could eventually find a genuine causative link between the two. But just last week, researchers elsewhere published a paper in Nature Medicine that found people taking semaglutide were actually less likely to report suicide ideation than those taking other weight loss drugs.

For now, the FDA is recommending that no one stop taking GLP-1s without first talking with their doctor. It’s also asking doctors to monitor for and ask patients to report “new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior” following GLP-1 use.