A new study has associated Ozempic and other GLP-1 agonists with rare but fatal adverse psychiatric events, emphasizing the need for further investigation.
GLP-1 receptor agonists have been used to treat type 2 diabetes since the early 2000s. The drugs skyrocketed in popularity in recent years, partly due to the off-label use for weight loss.
The increasing utilization raised concerns over severe side effects, ranging from suicide ideation to stomach paralysis.
A new study published in the International Journal of Clinical Pharmacy investigated the link between semaglutide, liraglutide, and tirzepatide — types of GLP-1 receptor agonists — and psychiatric adverse events.
The researchers looked at a European database including self-reported side effects between January 2021 and May 2023.
During this period, 481 psychiatric adverse events were identified, with depression being the most commonly reported (50.3%), followed by anxiety (38.7%) and suicidal ideation (19.6%).
Nine deaths occurred, primarily among men, resulting from completed suicidal attempts and depression. Another eleven patients had life-threatening outcomes.
The authors noted that despite psychiatric adverse events comprising only 1.2% of the total reports for adverse events caused by GLP-1 receptor agonists, “the severity and fatal outcomes of some of these reports warrant further investigation.”
The European Medicines Agency and regulators in the United Kingdom are currently looking into the reports from patients who experienced suicidal thoughts or thoughts of self-harm while on GLP-1 receptor agonists.
However, the existing evidence is conflicting. A recent study funded by the National Institutes of Health found that people taking semaglutide had a 49% to 73 lower risk of suicidal thoughts or ideation than patients on other weight loss or diabetes control medications.
Some healthcare professionals in the United States are now prescribing Ozempic for the treatment of weight gain caused by depression and psychosis medications.
Calls for better screening
The new study does not establish the causal relationship between GLP-1 receptor agonists and adverse psychiatric events.
Nevertheless, the authors recommend screening patients for pre-existing psychiatric conditions before prescribing GLP-1 receptor agonists. Moreover, patients taking the medications should be regularly monitored for signs and symptoms of depression, anxiety, and suicidal ideation.
The researchers call regulatory agencies to carefully review the safety data for GLP-1 receptor agonists and consider requiring additional warnings and precautions on drug labels.
They write, “Neuropsychiatric safety should be a key consideration in any randomized clinical trial and clinical risk-benefit assessment associated with GLP1 anti-obesity medications.”
Concern over gastrointestinal effects
Meanwhile, anecdotal reports and growing evidence link GLP-1 agonists to gastrointestinal issues.
A 2023 study suggests that diabetes-free patients taking medications for weight loss are at an increased risk of stomach paralysis, bowel obstruction, and inflammation of the pancreas.
However, another recent study suggests that type 2 diabetes patients who use GLP-1 receptor agonists are not at a higher risk of pancreatic cancer compared to those who use insulin only.
With the demand for GLP-1 receptor agonists only increasing, it is crucial to understand possible side effects better.