Ozempic not linked to suicidal thoughts, US and European health agencies say

Health agencies in the United States and Europe say there is no evidence that thoughts of suicide or self-harm are linked to semaglutide, a popular weight loss and diabetes drug sold under the brand names Ozempic and Wegovy.

After a nine-month review, the European Medicines Agency concluded Friday that “available evidence does not support a causal association” between GLP-1 receptor agonists, the class of drugs that includes semaglutide, and pansies or suicidal actions.

The Food and Drug Administration reached a similar conclusion in January. The agency reviewed reports of suicidal thoughts or actions in its adverse event reporting system, but a preliminary review found there was no clear link to drug agonist use. GLP-1 receptors. However, the FDA said in a statement that it “cannot definitively rule out that a slight risk may exist” and would continue to review the matter.

As semaglutide has gained popularity in the last year, a small number of users have reported suicidal thoughts while taking it.

As of December, the FDA’s adverse event reporting system had received 157 reports of suicidal ideation attributed to Ozempic and 18 attributed to Wegovy. For comparison, more than 2.6 million people in the United States received semaglutide between January 2018 and September 2023, according to data provided to NBC News by Epic Research, a health analytics company.

“I don’t think we can say the issue is completely closed, but the evidence we have so far is reassuring,” said Dr. Eduardo Grunvald, a physician specializing in obesity medicine at UC San Diego Health. He is a consultant for Novo Nordisk, the maker of Ozempic and Wegovy, but did not speak on behalf of the company.

Novo Nordisk told NBC News that it “stands behind the safety and effectiveness” of its GLP-1 medications when used correctly and taken under the care of a licensed healthcare professional. The company said it will continue to monitor reports of adverse reactions, including suicide and suicidal ideation.

“We look forward to working with the FDA as it completes its review,” the company said in a statement.

The FDA approved Wegovy for weight loss in 2021. The agency requires that any chronic weight management medication that acts on the central nervous system carry a warning about suicidal ideation. Wegovy fits that bill, which is why its prescription label tells doctors to watch for depression or suicidal thoughts.

Ozempic, a different strength of semaglutide, carries no such warning, since it is only approved to treat type 2 diabetes — although some doctors prescribe it off-label for weight loss.

Semaglutide has been shown in trials to significantly lower blood sugar levels and reduce body weight by an average of 15%.

“Overall, it is clear that the benefits are winning the race against the risks of these drugs,” Grunvald said.

A Nature Medicine study in January found that people taking semaglutide were up to 73% less likely to report suicidal thoughts than people taking other medications for weight loss or diabetes.

The study analyzed the medical records of nearly 1.6 million patients with type 2 diabetes and more than 240,000 patients with obesity. One particular analysis followed two groups, each including about 53,000 patients who were obese or overweight but had no history of suicidal thoughts. The first group was prescribed semaglutide, while the second was prescribed anti-obesity drugs that were not GLP-1 receptor agonists. After about six months, no one in the semaglutide group had reported a suicide attempt, while 14 people in the other group had.

The trend was similar for people with a history of suicidal thoughts, overweight or obese, as well as those taking semaglutide for type 2 diabetes.

“We found a lower risk associated with semaglutide compared to other drugs, but we don’t yet know the exact mechanism,” said Rong Xu, the study author and professor of biomedical informatics at the Case Western Reserve University.

“We are not saying that the risk is zero,” she added. “We just compared to other medications and we didn’t see an increase.”

Doctors who regularly prescribe semaglutide say there may be other reasons why patients taking the drug report suicidal thoughts. Among their main theories: Semaglutide mimics a hormone in the gut that signals people that they are full and therefore eat less. This could have a negative effect on people’s moods if they habitually consume food to cope with depression.

“That doesn’t mean it causes suicidal thoughts. It just means it can dull the pleasure you get from certain foods you’re used to eating to hide your feelings of depression,” said Dr. Caroline Apovian, co-director of the Center for Weight Management and Wellness. from Brigham and Women’s Hospital. , who serves on the scientific advisory board of Novo Nordisk.

Bariatric surgery works similarly in terms of appetite suppression, Apovian said, and suicide rates are at least four times higher among people who have had bariatric surgery than in the general population.

However, for the most part, doctors say that semaglutide improves the health of obese patients.

“In my clinical experience, people in general feel much better after losing this weight,” Grunvald said. “They feel better physically, but also often better emotionally.”

If you or someone you know is in crisis, call 988 to reach the Suicide and Crisis lifeline. You can also call the network, formerly known as the National Suicide Prevention Lifeline, at 800-273-8255text HOME to 741741 or visit SpeakingOfSuicide.com/resources for additional resources.

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