In the Effects’ section, stroke, myocardial This is considered acceptable. noted above stroke, myocardial infarction, sudden ‘Adverse ‘As infarction, sudden hypertension, and growth death, hypertension, and growth suppression are listed in suppression should be included in the table provided. the Precautions sections as adverse events that have been These adverse events are already mentioned in the reported or associated with amphetamines. The adverse proposed PI in the section, but should be drug reaction section of the PI contains adverse drug ‘Precautions’ repeated in the table shown in the Events’ reactions that have been determined by the MAH to have ‘Adverse section for the purpose of completeness. sufficient evidence to be an adverse drug reaction with lisdexamfetamine. To date the MAH does not consider stroke, myocardial infarction, sudden death, hypertension and growth retardation as adverse drug reactions related to LDX.’
In the ‘Adverse Effects’ section, stroke, myocardial infarction, sudden hypertension, and growth suppression should be included in the table provided. These adverse events are already mentioned in the proposed PI in the ‘Precautions’ section, but should be repeated in the table shown in the ‘Adverse Events’ section for the purpose of completeness. ‘As noted above stroke, myocardial infarction, sudden death, hypertension, and growth suppression are listed in the Precautions sections as adverse events that have been reported or associated with amphetamines. The adverse drug reaction section of the PI contains adverse drug reactions that have been determined by the MAH to have sufficient evidence to be an adverse drug reaction with lisdexamfetamine. To date the MAH does not consider stroke, myocardial infarction, sudden death, hypertension and growth retardation as adverse drug reactions related to LDX.’ This is considered acceptable.
auspar-lisdexamfetamine-dimesilate-131023.docx