The US government agency responsible for regulating drugs has stated that there is currently no proof to suggest a connection between weight-loss medications and suicidal thoughts.
On Thursday, the U.S. Food and Drug Administration announced that their initial evaluation did not discover any indication that weight-loss medications, including NOVOb.CO Wegovy by Novo Nordisk, were linked to suicidal thoughts. The agency plans to further research this matter.
However, despite the FDA acknowledging that suicidal thoughts are listed as a potential safety concern for these drugs, they stated that they cannot completely dismiss the possibility of a small risk due to the lack of extensive data.
Both Wegovy and Eli Lilly’s LLY.N Zepbound are classified as GLP-1 agonists, which were initially intended for treating type 2 diabetes. Along with regulating blood sugar levels, they also induce a sensation of satiety.
Dr. Robert Kushner, a professor at Northwestern University Feinberg School of Medicine, explains that the concept of cautioning against suicidal thoughts in relation to weight loss treatments stems from previous research on medications that functioned differently from GLP-1s.
According to Kushner, there is a historical impact that currently affects all medications used for treating obesity.
Recently, a study conducted in the United States concluded that there is no indication of a correlation between the use of Novo Nordisk’s medications, Ozempic and Wegovy, and an increase in suicidal ideation.
Last year, reports of suicidal thoughts linked to semaglutide, the main component in Wegovy and Ozempic, caused concern and prompted an investigation by the European Medicines Agency. In December, the European regulator requested additional information from Novo Nordisk.
The FDA stated that after conducting a thorough analysis of clinical trials and utilizing the FDA Adverse Event Reporting System (FAERS), they did not find a definitive correlation between the medications and suicidal ideation or behaviors.
Kushner stated that it was wise to consistently observe individuals taking GLP-1 medications, and that information gathered from prolonged usage of the drugs could potentially ease any worries.
According to the FDA, health care professionals such as doctors have a responsibility to observe their patients for signs of emerging or worsening depression, suicidal ideation, or any unusual shifts in mood or behavior. This should align with the guidance provided for the use of prescribed medications.
After finishing its evaluation, the organization will release its ultimate suggestions.