Lizdexamfetamine dimesylate: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — EMEA / H / N / PSR / S / 0033


Although the overall study results provide no evidence of increased cardiovascular risk, these overall estimates are derived from the study population, in which most patients had short-term LDX exposure. In an analysis of long-term LDX use, there was a higher estimated risk of MACE among LDX users compared to what was observed in the overall [...]