Details Basic Details Status Ongoing Last Updated Thursday, January 11, 2024 Original Posting Date Thursday, January 11, 2024 Health Outcome(s) intentional self-harm Purpose Drug and Outcome Analysis Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR No Regulatory Link(s) (1) FDA Safety Communication: Update on FDA's Ongoing Evaluation of Reports of Suicidal Thoughts or Actions in Patients Taking a Certain Type of Medicines Approved for Type 2 Diabetes and Obesity