BioPharma Dive January 12, 2024
Regulators will continue to evaluate suicide ideation as the data don’t “definitively rule out” the danger.
Dive Brief:
- The use of GLP-1-based drugs to treat obesity and diabetes has no “clear relationship” with the risk of suicidal thoughts or actions, the Food and Drug Administration said Thursday after completing a review of reports in its adverse events reporting system and clinical trial data.
- Regulators plan on continuing to evaluate suicide risk by pooling data from several clinical of GLP-1 drugs like Ozempic and Mounjaro, as well as analyzing data from a large database of insurance claims and patient records. The European Medicines Agency is also examining this issue, with another meeting planned for April.
- The FDA’s announcement follows a...
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