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The following adverse reactions have been associated with the abrupt discontinuation of the individual components of QSYMIA: For topiramate, abrupt discontinuation has been associated with seizures in patients without a history of seizures or epilepsy [see Warnings and Precautions (5.9)]

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Meta-analyses of cardiometabolic outcome trials of GLP-1RAs demonstrate approximately 15%20% lower stroke incidence in people with diabetes and obesity (195197), with recent data extending benefits to nondiabetic populations (198, 199)

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Companies operating in this space should take these developments seriously, review their compliance programs immediately, and prepare for a regulatory landscape that will only become more demanding in the months ahead