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FDA Investigates Hair Loss and Suicidal Thoughts Linked to Diabetes and Weight Loss Drugs

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) is actively examining reports of alarming side effects associated with popular medications used for diabetes and weight loss, including hair loss and suicidal thoughts. The drugs in question, classified as GLP-1 receptor agonists, include semaglutide (Ozempic, Rybelsus, Wegovy), liraglutide (Saxenda, Victoza), and tirzepatide (Mounjaro, Zepbound). These medications, approved for managing diabetes and aiding in weight loss, mimic the actions of the naturally occurring GLP-1 hormone.

The FDA Adverse Event Reporting System (FAERS) has received reports linking the use of these drugs to adverse effects such as alopecia (hair loss), aspiration (accidentally inhaling substances like food or liquid), and suicidal ideation. However, the FDA emphasizes that the inclusion of a drug on the list does not imply a conclusive determination of associated risks but signifies the identification of potential safety concerns.

Individuals currently using these medications are advised by the FDA to consult with their healthcare providers if they have questions or concerns about potential side effects. The agency reassures the public that it continuously monitors drug safety throughout their life cycle, employing postmarketing surveillance and risk assessment programs.

The FDA is considering regulatory actions based on its comprehensive review of available data. Potential measures could include requiring labeling changes or implementing a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the medication outweigh the associated risks.

Previous research has linked GLP-1 agonists to digestive issues such as stomach paralysis, pancreatitis, and bowel obstructions, although these events are considered rare. The American Society of Anesthesiologists recommended a temporary discontinuation of GLP-1 agonists before surgical procedures due to the drugs’ potential gastrointestinal effects.

European regulators have been investigating the risk of suicidal thoughts associated with these medications for several months. Companies manufacturing these GLP-1 agonists, including Novo Nordisk and Eli Lilly, emphasize their commitment to patient safety and active collaboration with the FDA to monitor and address safety concerns.