Khaberni - The U.S. Food and Drug Administration (FDA) has asked pharmaceutical companies to remove warnings related to the possibility of suicidal thoughts from the labels of popular medications for weight loss and blood sugar control, including Novo Nordisk's "Wegovy" and Eli Lilly's "Zybond."
The decision also includes "Saxenda," an older version of Novo Nordisk's weight loss medications, following a comprehensive review by the agency which found no evidence linking the use of these medications with an increased risk of suicidal thoughts or behaviors.
The agency stated in a release that these medications were originally developed to treat type 2 diabetes, as they mimic a hormone that suppresses appetite, providing a feeling of fullness and aiding in weight loss.
The agency had reached a similar conclusion in a preliminary review conducted in 2024, but noted at the time that it could not rule out a minimal risk due to the limited data available.
The "FDA" added that it recently conducted additional analyses involving expanded clinical trials, and the results showed no increase in the risk of suicidal thoughts or behaviors in users of these medications, nor did it detect an increase in other psychological side effects, such as anxiety, depression, nervousness, or psychosis.
According to the agency, the review covered 91 clinical trials involving 107910 patients, including 60338 patients who received medications for blood sugar control, compared to 47572 patients who received a placebo treatment.
The agency pointed out that the results of this review support the removal of previous warnings while continuing long-term pharmacovigilance monitoring of these treatments.
