(Reuters) -The U.S. Food and Drug Administration said on Thursday its preliminary review did not find evidence that weight-loss drugs such as Novo Nordisk’s Wegovy were tied to suicidal thoughts.
Still, the agency, which has listed suicidal thoughts as a potential safety signal for such drugs, said it could not definitively rule out that a small risk may exist as it continues to study the issue.
Wegovy and Eli Lilly’s Zepbound belongs to a class of drugs known as GLP-1 agonists, originally designed for type 2 diabetes. In addition to helping control blood sugar levels, they trigger a feeling of fullness.
A large U.S. study last week found no evidence that taking Novo Nordisk’s Ozempic or Wegovy is tied to an increase in suicidal thoughts.
Concerns over reports of suicidal thoughts associated with semaglutide, the active ingredient in Wegovy and Ozempic, triggered an investigation by the European Medicines Agency last year. The European regulator has asked for more information from Novo Nordisk in December.
The FDA said its months-long evaluation of clinical trials, as well as its public dashboard called the FDA Adverse Event Reporting System (FAERS) did not show a clear relationship between the drugs and suicidal thoughts or actions.
The agency said it would announce its final conclusions and recommendations after the completion of the review.
Healthcare providers like doctors should monitor their patients for new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior, consistent with the prescribing information for the drugs, the FDA said.
Demand for Novo’s obesity drug Wegovy and diabetes drug Ozempic, widely used off-label, has overwhelmed the Danish drugmaker and has left it scrambling to boost output.
Eli Lilly’s Zepbound, which uses the same active ingredient as its diabetes drug Mounjaro, was approved by the FDA in November.
Lilly CEO David Ricks said on Monday Zepbound hit 25,000 new prescriptions per week at the end of December, and that its 2024 supply may not be enough to meet demand.
(Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber and Sriraj Kalluvila)
