BioPharma Dive January 12, 2024
Jonathan Gardner

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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Topics: Biotechnology, FDA, Govt Agencies, Patient / Consumer, Pharma, Pharma / Biotech, Provider
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