Popular weight-loss drugs linked to suicidal thoughts among users

European regulators are reviewing several popular weight-loss drugs like Ozempic for reportedly inducing suicidal thoughts among some users, according to a BBC News report.

Iceland’s health watchdog agency first flagged the problem, reporting at least two incidents of suicidal thoughts linked to Novo Nordisk’s Ozempic and Saxenda, and one case of self-harm ideation to Saxenda.

The European Medicines Agency (EMA) is investigating the reports.

The EMA said it will investigate weight-loss medications that contain either semaglutide or liraglutide, but that it may expand the probe to other drugs in the same class, known as GLP-1 receptor agonists, a spokesperson told the BBC.

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GLP-1 receptor agonists originally were used to treat Type 2 diabetes, but are now being developed to treat obesity.

Novo Nordisk’s latest hit weight-loss drug, Wegovy, also uses semaglutide, and Eli Lilly, Amgen and Pfizer are developing GLP-1 receptor agonists.

The drugs under review carry an extensive list of side effects. In U.S. labeling, the product information lists thoughts of suicide as a possible side effect, but the European Union product information does not.

This review was announced just weeks after the EMA raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including Novo’s semaglutide products and weight-loss drugs made by AstraZeneca and Sanofi.

Novo Nordisk said in a statement that it takes all reports about adverse events from the use of its medications very seriously, that patient safety is a top priority and that it had found no “causal association” between suicidal thoughts and the drugs.

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Commenting on the EMA investigation, a U.S. Food and Drug Administration (FDA) spokesperson told Bloomberg News, “If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence.”

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The spokesperson said that clinical trials for Wegovy did not support an increased risk of suicidal ideation, but clinical trials for other weight-loss drugs had.

According to the FDA Adverse Events Reporting System (FAERS) Public Dashboard, there have been at least 60 reports of suicidal ideation since 2018 from patients on semaglutide or their healthcare providers, Reuters reported.

CNN reported that in the clinical trials for Saxenda for adults, nine people out of 3,300 taking the drug reported suicidal ideation, compared with two of more than 1,900 who received a placebo.

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One adult on Saxenda attempted suicide, the prescribing information says. In pediatric clinical trials, one of 125 taking Saxenda died by suicide. The prescribing information says “There was insufficient information to establish a causal relationship to Saxenda.”

An earlier weight-loss drugs — Sanofi’s Acomplia (rimonabant) — was pulled from European markets because it caused suicidal ideation. It never won approval in the U.S.

Studies show that when people stop taking them, they regain much of the weight they lost, or potentially gain even more weight. Most people who start taking the drugs and want the effects to last will have to stay on them long-term.

But recent pharmacy claims data shows that most people who start taking Wegovy stop taking it within a year, some because of side effects and some because of the high cost of the drugs.

There was an increased risk of diabetic retinopathy. Studies also suggest using semaglutide may lead to adverse kidney events.

In addition to thyroid cancer, researchers have raised concerns about the potential risk for pancreatic carcinoma associated with the drug.