FDA is requesting that drug application holders remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that currently include such language. The affected products are Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide). This action follows a comprehensive FDA review that found no increased risk of SI/B associated with the use of GLP-1 RA medications. Saxenda, Wegovy, and Zepbound are each approved for weight reduction in persons with obesity or overweight. At the time of the original FDA approvals, the labeling for each of these products included information in the Warnings and Precautions section about the potential risk of SI/B. Similar information about SI/B is also included in the labeling of other types of weight loss medicines and is based on reports of such events observed with a variety of older medicines used or studied for weight loss.
Labeling for GLP-1 RA medications that are approved to improve glycemic (blood sugar) control or other complications in patients with type 2 diabetes mellitus does not currently include information on the risk of SI/B. Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 RA medications.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!