The Food and Drug Administration said Tuesday that it wants suicide warning labels on GLP-1 weight-loss drugs to be removed.
The FDA did a review of 91 trials comparing GLP-1 users to placebo groups. The agency found that the 60,338 people across the trials who took the weight loss drugs did not show any increased risk of suicidal ideation or behavior compared to the 47,572 people in the placebo groups.
The affected drugs were liraglutide, sold by Novo Nordisk as Saxenda; semaglutide, sold by Novo Nordisk as Wegovy; and tirzepatide, sold by Eli Lilly as Zepbound, the FDA said.
The new requested labeling for the weight loss drugs matches the labels for their equivalents prescribed for type 2 diabetes — Novo Nordisk’s Ozempic and Rybelsus and Eli Lilly’s Mounjaro.
The labels for those medicines never included verbiage related to suicidal thoughts or actions.
An Eli Lilly spokesperson told industry news site Pharmaceutical Technology that “we appreciate the FDA’s careful consideration of this important safety issue. Patient safety is Lilly’s top priority, and we will continue to work with the FDA on next steps to ensure that appropriate safety information is available to prescribers.”
A Novo Nordisk spokesperson told Pharmaceutical Technology that “we are happy to see the FDA’s recommendation to remove the warning regarding the risk of suicidal ideation and behaviour … We prioritise patient safety and will continue to collaborate closely with the FDA and other regulatory authorities.”
