- Officials in Europe are investigating the possible risk of people on Ozempic developing suicidal thoughts.
- Suicidal thoughts or thoughts of self-harm are not listed as possible side effects in the EMA product information for either Ozempic or Saxenda.
- These drugs stimulate the release of insulin after someone eats, which can help lower blood sugar levels. They are also associated with weight loss.
The European Medicines Agency’s safety committee is investigating a possible risk of suicidal thoughts and thoughts of self-harm from certain drugs used to treat obesity and diabetes, according to a statement July 11.
The investigation comes after the Icelandic Medicines Agency identified two cases of suicidal thoughts, one after use of Ozempic and another following use of Saxenda. Another case involved thoughts of self-harm after use of Saxenda.
Ozempic, which contains semaglutide, is approved in the United States by the Food and Drug Administration as a treatment for type 2 diabetes. Semaglutide is also approved by the FDA under the brand name Wegovy as a treatment for obesity.
Saxenda, which contains the active ingredient liraglutide, is used to treat obesity. All three drugs are made by Danish firm Novo Nordisk.
“The review is being carried out in the context of a signal procedure. A signal is information on a new adverse event that is potentially caused by a medicine or a new aspect of a known adverse event that warrants further investigation,” the EMA said in a statement. “The presence of a signal does not necessarily mean that a medicine caused the adverse event in question.”
The regulator said in the statement that its safety committee is evaluating the risk of suicidal thoughts and thoughts of self-harm in people who used a drug containing semaglutide or liraglutide for weight loss.
In a statement sent to Healthline, Novo Nordisk said: “Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from use of our medicines very seriously.”
“GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide that have been on the market for more than 10 years,” it added.
These drugs mimic the action of a hormone called
Novo Nordisk said in its statement that it does ongoing safety monitoring of its products, and is “confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”
The FDA also
Dr. Kishore M. Gadde, a psychiatrist with UCI Health in Orange, Calif., said the cases identified by the Icelandic Medicines Agency suggest a possible link between the drugs and suicidal thoughts and behavior, but don’t show causality.
This fits with the adult clinical trials for Saxenda, which showed that less than 1% of people treated with the drug reported suicidal thoughts, according to prescribing information for the drug. A similar rate occurred among people who received an inactive placebo.
“So there was a signal [of a possible link] in the Saxenda trials, but it was not strong enough to establish causality,” Gadde told Healthline.
However, an earlier anti-obesity medication,
“Given the experience with Acomplia [rimonabant], the EMA will likely rule in favor of adding a note about possible suicidal ideation in the product information for [the newer] medications as a precautionary measure,” Gadde said.
Dr. Mir Ali, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, Calif., doesn’t see these isolated cases as a major concern for people using these medications.
“Ozempic and other drugs in that category have been around for a number of years, and [suicidal thoughts and behavior] haven’t been shown to be a significant side effect or concern,” he told Healthline.
“Any time there is any kind of anecdotal report like this, it has to be investigated,” he said. “So I think the EMA review is a good idea.”
However, he recommends that doctors more closely monitor people who have a history of suicidal thoughts and behaviors.
These people “should stay in touch with either their primary doctor or their psychiatrist,” he said. “If they feel that these [suicidal] thoughts are more frequent or are affecting them, they should talk to their doctor or seek help at the emergency department.”
He recommends that these people be monitored carefully when treated for weight management. Warning signs include: hopelessness, threats to harm self, writing or talking about suicide, withdrawing from others, and impulsive or reckless actions.
In addition, “rapid and significant weight loss might itself increase the risk of suicide ideation, although it is not entire clear why,” he said, pointing out that this risk has been seen in people who have had bariatric surgery.
“Thus, the issue of suicidal risk is not unique to weight management medications,” he said.
Officials in the European Union are investigating a possible risk of suicidal thoughts and thoughts of self-harm from certain drugs used to treat obesity and diabetes.