The Food and Drug Administration announced on Thursday that popular obesity and Type 2 diabetes medications do not have a clear risk of patients developing depression and suicidal thoughts.
The agency published its initial findings after a monthslong review of information from the FDA Adverse Event Reporting System on the entire drug class of GLP1 RAs, which include Ozempic, Wegovy, Mounjaro, and Zepbound.
Although there have been several reports of depression and suicidal thoughts associated with GLP1 RAs, the FDA found that the reported incidences “did not demonstrate a clear relationship” between the drugs and adverse mental health outcomes.
Although the FDA did not find a strong statistical relationship in the FAERS data, the agency said it “cannot definitively rule out that a small risk may exist” due to the small number of poor outcomes that have been identified.
Novo Nordisk — maker of both Ozempic for Type 2 diabetes and Wegovy for obesity — told the Washington Examiner that patient safety is their top priority.
“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,” a spokesperson for the Danish pharmaceutical company told the Washington Examiner.
Despite their recent rise in popularity, GLP1 RAs have been used to treat Type 2 diabetes for more than 18 years and for the treatment of obesity for eight years.
According to FDA regulation, weight management medication Wegovy must carry warning labels regarding suicidal ideation and action, as have older obesity treatments.
The spokesperson also said that the company “is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with authorities to ensure patient safety and adequate information to healthcare professionals.”
American pharmaceutical giant Eli Lilly, maker of Mounjaro for Type 2 diabetes and Zepbound for obesity, did not respond to the Washington Examiner’s request for comment.
The FDA instructed that patients should not discontinue use of any GLP1 RA medication without first consulting their healthcare provider because “stopping these medications may worsen” a patient’s condition.
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The agency is continuing its investigation by examining postmarketing data in the Sentinel System, a large data network containing health insurance claims and patient records that is used to monitor the safety and efficacy of FDA-regulated products.
“We will communicate our final conclusions and recommendations after we complete our review or have more information to share,” the agency said.
A Lilly spokesman told the Washington Examiner: “Following rigorous study for many years in clinical trials and a robust approval process, medicines continue to be monitored by the FDA and manufacturers for safety. Patient safety is Lilly’s top priority, and we will continue to collaborate with the FDA as they complete their evaluation. If someone is experiencing side effects while taking any Lilly medication, we encourage them to speak with their healthcare provider.”
