Good
Mostly Aligned
Patient Risk:
Low
Summary
The provided content aligns with the boxed warning and Section 5.1/9.2 labeling for abuse, misuse, addiction/substance use disorder, and overdose/death risk, including increased risk with higher doses or unapproved administration (snorting/injection). No contradictions were identified.
Category Scores
Accurate Statements
MYDAYIS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
BOXED (ABUSE, MISUSE, AND ADDICTION); 5.1 (Abuse, Misuse, and Addiction); 9.2 (Abuse)
Misuse and abuse of CNS stimulants, including MYDAYIS, can result in overdose and death.
BOXED (ABUSE, MISUSE, AND ADDICTION); 5.1 (Abuse, Misuse, and Addiction); 9.2 (Abuse)
The risk is increased with higher doses or unapproved methods of administration such as snorting or injection.
5.1 (Abuse, Misuse, and Addiction)
Unsupported Statements
Contradictions
Important Omissions
No inclusion of other label elements related to abuse/misuse management (e.g., instructions to assess risk before prescribing, educate patients/families, storage/disposal guidance, and frequently monitor for signs/symptoms).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
Only on-label high-level abuse/misuse/addiction and overdose/death risk statements were assessed; key risk-management instructions were not included but were not contradicted.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Omission of label-listed patient risk assessment/education, storage/disposal, and monitoring instructions within the abuse/misuse guidance.
Suggested Improvement
Include the boxed warning/5.1 guidance elements: assess each patient’s risk before prescribing, educate patients/families, instruct on safe storage and disposal, reassess risk throughout treatment, and frequently monitor for signs/symptoms of abuse/misuse/addiction.