FDA Scrutinizes Side Effects of Diabetes, Weight-Loss Drugs

The Food and Drug Administration has identified potential safety issues regarding diabetes and weight-loss medications such as Ozempic and Mounjaro, including hair loss, aspiration, and suicide ideation.

The FDA Adverse Event Reporting System (FAERS) received reports of patients also experiencing alopecia and aspiration while taking glucagon-like peptide-1 (GLP-1) receptor agonists, the category under which Ozempic and Mounjaro fall, The Hill reported Thursday.

On the FAERS website, it said the FDA is evaluating the need for further regulation regarding the alleged side effects.

GLP-1 receptor agonists, which mimic a natural hormone whose roles include slowing the passage of food through the stomach, are approved to treat diabetes or weight loss, CNN reported Thursday. They include semaglutide, branded as Ozempic, Rybelsus and Wegovy; liraglutide, branded as Saxenda and Victoza; and tirzepatide, branded as Mounjaro and Zepbound.

The FDA advised people who use such medications and have questions or concerns about side effects should speak with their healthcare provider, according to CNN.

Novo Nordisk, the exclusive patent holder of semaglutide, said gastrointestinal issues such as nausea, diarrhea, and constipation are the most common side effects, The Hill reported. According to the medication guide for Ozempic, other side effects can include pancreatitis, kidney failure, low blood sugar, and changes in vision; but hair loss, depression, and aspiration are not included.

Novo Nordisk said inclusion on the FAERS list does not definitively mean the drug has the risk for which it's being evaluated.

"The known risks associated with use of those medicines are reflected in their current FDA-approved product labeling," the company told The Hill. "Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional."

European regulators have also been investigating the risk of suicidal thoughts in people taking such medications, CNN reported, although it's not known whether the medicines caused the events or they might be linked to other underlying conditions.

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