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FDA asks makers to drop suicidal-thoughts warning from GLP-1 weight-loss drug labels

Safety

In an updated drug safety communication, the FDA said its review found no increased risk of suicidal ideation or behavior with GLP-1 receptor agonists and asked manufacturers to remove the warning from the labels of Saxenda (liraglutide), Wegovy (semaglutide) and Zepbound (tirzepatide). The review included a meta-analysis of 91 placebo-controlled trials with 107,910 patients and a claims-data study of more than 2.2 million people comparing GLP-1 drugs with SGLT2 inhibitors.

Sources

  1. 01FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications(opens the source in a new tab) U.S. Food and Drug Administration
  2. 02FDA Finds No Increased Suicide Risk With GLP-1 Medications, Requests Removal of Warning Labels(opens the source in a new tab) Pharmacy Times

Peptides involved

  1. ApprovedLiraglutideGLP-1 receptor agonist31
  2. ApprovedSemaglutideGLP-1 receptor agonist31
  3. ApprovedTirzepatideDual GIP and GLP-1 receptor agonist39