FDA says it is requesting that drug application holders remove information regarding suicidal ideation and behavior from the labeling of certain GLP-1 receptor agonist medications, specifically Saxenda, Wegovy, and Zepbound. The agency says this follows a comprehensive review that did not identify an increased risk of suicidal ideation or behavior with GLP-1 RA use.
FDA says its meta-analysis covered 91 placebo-controlled GLP-1 RA trials involving 107,910 patients and did not show increased risk for suicidal ideation or behavior or for related psychiatric adverse events such as anxiety, depression, irritability, or psychosis.
This is an important safety story because it shows that postmarketing and pooled evidence can move labeling in both directions. Inference: pharmacovigilance is not only about adding warnings; sometimes it is also about removing or narrowing them when the evidence does not support continued concern.
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