A new study suggests that patients using a popular diabetes and weight-loss drug, Ozempic, may experience a higher incidence of suicidal thoughts, sparking renewed debate over the drug’s safety.
The study, released on Tuesday in the JAMA Network Open, affiliated with the American Medical Association, is the first to analyze the World Health Organization’s (WHO) database of suspected side effects for instances of suicidal ideation among users of the drug. The findings indicate that a higher proportion of these reports came from patients who had taken semaglutide—the active ingredient in Novo Nordisk’s Ozempic for diabetes and Wegovy for weight loss—compared to those using other medications.
The study’s thorough methodology has prompted calls for increased caution among healthcare providers. Francesco Salvo, a pharmacologist at the University of Bordeaux, emphasized in an accompanying editorial that physicians should be particularly vigilant when prescribing semaglutide to individuals with a history of depression or suicide attempts.
However, not all experts agree on the implications of the findings. Some have criticized the evidence as weak and inconclusive. Stephen Evans, emeritus professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, pointed out significant limitations in the study. “Spontaneous reports from patients, like those found in the WHO database, are highly susceptible to bias, including the influence of media coverage,” he said.
The study authors acknowledged that WHO’s database lacks critical contextual information, such as the duration of treatment, which could provide a more accurate understanding of the risks. They also noted potential biases stemming from the reliance on self-reported data from patients and their physicians.
Earlier this year, the U.S. Food and Drug Administration (FDA) conducted a preliminary review and found no conclusive evidence that drugs like Ozempic and Wegovy cause suicidal thoughts or behaviors. However, the agency has not dismissed the possibility of a small risk and continues to investigate the issue.
In a similar vein, the European Medicines Agency’s (EMA) risk assessment committee concluded in April that there was no added risk of suicide or self-harm associated with these medications. Novo Nordisk has stated that these regulatory findings are consistent with data from clinical trials and has committed to ongoing collaboration with regulators to monitor the safety of the drugs. This includes continued surveillance of data from ongoing studies and real-world usage.
The use of weight-loss drugs like Ozempic has surged in recent years, with high-profile figures such as Elon Musk, Oprah Winfrey, Whoopi Goldberg, and Rebel Wilson openly discussing their use of the injections. Ozempic was approved for use in the U.S. in 2017 and in the EU in 2018, quickly gaining popularity for its ability to help users shed significant amounts of weight with minimal effort.
In 2023 alone, 20 million prescriptions were written for Ozempic in the U.S., representing a staggering 5,000 percent increase since 2018. This surge in demand has led to global shortages of the drug, prompting warnings from authorities about the circulation of counterfeit injection pens.
As the debate over the safety of semaglutide continues, both patients and healthcare providers are urged to stay informed and cautious when considering or using this widely popular medication.
