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August 19, 2025

FDA Requires New Kidney Injury Warning for All GLP-1 Drugs

The FDA is requiring warning label changes to all glucagon-like peptide 1 (GLP-1) receptor agonist medications – a newer class of drugs used for the treatment of diabetes and obesity – regarding the risk of serious kidney injury that can result from dehydration, requiring the need for hemodialysis treatment.

This new warning comes after the FDA’s MedWatch program – which monitors for potential drug risks that may not have emerged during clinical trial stages – received many reports from individuals who used these medications.

Side effects of these GLP-1 receptor agonists can include gastrointestinal issues such as vomiting, diarrhea, and nausea, which can result in volume loss. In more extreme cases, this can result in dehydration.

Typically, these gastrointestinal effects are more prevalent when first starting the medication or when increasing dosage.

Healthcare providers are advised to look for signs of renal function decline in patients taking GLP-1 receptor agonists who have experienced these gastrointestinal issues, as they could lead to dehydration, and possibly kidney damage.

Patients are recommended to stop taking GLP-1 receptor agonists at the first sign of dehydration or kidney issues – such as dark urine, infrequent urination and dizziness – and to seek medical care.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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