Issue Resolution Related to Convulsive Profiles

Abstract Numerous drugs designed for and used in clinical settings induce convulsions, seizures, or both. The resolution of this issue depends on the assessment and management of the risk of drug-related convulsions and seizures, which may help to ensure the safe use of products containing these drugs. Risk assessments help determine the exposure levels at which these toxicities occur, demonstrate the biological plausibility of these toxicities, and characterize the toxicities of interest. Risk related to these toxicities may be characterized based on data from published studies, original studies, or both. This characterization typically requires evaluating the mechanism, as well as the qualitative, quantitative, and temporal properties of the toxicities of interest. Ultimately, insights gained from the risk assessment may help to create a risk management plan to mitigate the risks identified.