The regulator is launching an investigation of Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound and other GLP-1 receptor agonists following patient reports of suicidal ideation, alopecia and aspiration.
Pictured: FDA signage in its office in Washington, DC/iStock, JHVEPhoto
The FDA is looking into several GLP-1 receptor agonists—including Novo Nordisk’s semaglutide and Eli Lilly’s tirzepatide—for potential side effects such as suicidal ideation, alopecia and aspiration, or accidentally breathing in foreign objects into the airway.
The investigation follows patient reports of these safety risks picked up by the FDA Adverse Event Reporting System (FAERS) from July 2023 to September 2023. The FDA is also probing other GLP-1 receptor agonists, including Novo’s liraglutide—sold under the brand names Saxenda and Victoza—and Lilly’s dulaglutide, which is marketed as Trulicity.
Being put on the list “does not mean that the FDA has concluded that the drug has the listed risk,” according to the FAERS website.
“If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions, including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk,” the website states.
The FDA probe comes as a large U.S. study found no evidence that taking Novo’s Ozempic or Wegovy was tied to an increase in suicidal thoughts, Reuters reported on Friday.
GLP-1 receptor agonists work by mimicking the GLP-1 hormone and inducing the pancreas to secrete insulin into the bloodstream in response to changes in glucose levels. Currently, the most dominant molecules in this class are semaglutide, which is approved as Novo’s Ozempic for type 2 diabetes and Wegovy for weight management, and tirzepatide, sold as Lilly’s Mounjaro for type 2 diabetes and Zepbound for obesity.
Despite the sky-high demand for these drugs and the multibillion-dollar promise of the weight-loss market, GLP-1 receptor agonists have in recent months been plagued by allegations of possible safety issues. In July 2023, the European Medicines Agency (EMA) flagged a potential risk of thyroid cancer associated with this drug class and asked manufacturers to submit “supplementary information” related to the matter.
A few days later, the EMA also launched a review of Ozempic and Saxenda for potential risks of self-harm and suicidal ideation, which was first recorded by the Icelandic Medicines Agency. The European Union regulator eventually expanded the review to cover other GLP-1 receptor agonists.
The U.K. followed suit soon after with its Medicines and Healthcare products Regulatory Agency similarly putting the drug class under investigation for potential risks of self-injury and suicidal thoughts.
GLP-1 receptor agonists have also been linked to gastrointestinal toxicities. In October 2023, a study published in the medial journal JAMA found that the drug class was associated with a heightened risk of pancreatitis, gastroparesis and bowel obstruction.
In August 2023, Novo and Lilly were both sued by a woman from Louisiana who claimed that the companies “downplayed the severity of the gastrointestinal events caused by Ozempic and Mounjaro.”
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
