Poor
Needs Review
Patient Risk:
Moderate
Summary
Only some safety/controlled-substance statements are supported by the provided FDA label excerpts (boxed warning, controlled substance, abuse/dependence). Many other dosing, indication, study, efficacy, and contraindication-like claims are not supported or contradicted by the provided label text, which is insufficient for those topics.
Category Scores
Accurate Statements
Vyvanse is a prodrug of dextroamphetamine.
Label excerpt (9.1): “VYVANSE contains lisdexamfetamine, a prodrug of amphetamine...”
Vyvanse can increase heart rate.
Label excerpt (9.2): “Misuse and abuse… may cause increased heart rate...”
Vyvanse can increase blood pressure.
Label excerpt (9.2): “Misuse and abuse… may cause… blood pressure...”
Vyvanse has potential for dependence.
Label excerpt (9.3): “VYVANSE may produce physical dependence.”
Vyvanse has potential for psychosis.
Label excerpt (9.2): “Anxiety, psychosis, hostility, aggression…”
Vyvanse is a Schedule II controlled substance.
Label excerpt (9.1): “…a Schedule II controlled substance.”
Vyvanse has abuse risk / high potential for abuse and misuse.
Boxed Warning and 5.1/9.2 excerpts: “VYVANSE has a high potential for abuse and misuse…”
Unsupported Statements
Vyvanse (lisdexamfetamine) is FDA-approved for moderate to severe binge eating disorder (BED) in adults.
The provided FDA label excerpts do not include the approved indication section.
Vyvanse approval for BED occurred in 2015.
No timeline/approval year is provided in the supplied label excerpts.
Vyvanse reduced binge episodes by about 50% over 12 weeks compared with placebo in Phase 3 trials.
No efficacy trial results are present in the supplied label excerpts.
Vyvanse boosts dopamine and norepinephrine in the brain.
No neurochemical mechanism statements are provided in the supplied label excerpts.
For BED, Vyvanse curbs impulse control and reward-driven eating.
The supplied label excerpts do not describe this mechanism/effect.
Vyvanse is taken at 50–70 mg daily.
No BED dosing regimen is provided in the supplied label excerpts.
Vyvanse dosing is titrated from 30 mg.
No titration/dosing guidance is provided in the supplied label excerpts.
In a 12-week study (n=373), 36% of Vyvanse patients had zero binge days per week versus 17% on placebo.
No study data endpoints are present in the supplied label excerpts.
A 26-week extension confirmed sustained effects.
No extension trial information is present in the supplied label excerpts.
The 26-week extension reported a 26% remission rate.
No remission-rate data is present in the supplied label excerpts.
Real-world data shows 40–60% response rates for Vyvanse in BED.
No real-world response data is present in the supplied label excerpts.
Adherence drops over time due to side effects.
No adherence/long-term behavioral adherence data is present in the supplied label excerpts.
Dry mouth, insomnia, headache, and anxiety affect over 20% of users.
No adverse reaction incidence percentages are provided in the supplied label excerpts.
Vyvanse has potential for dependence.
While dependence is supported, this statement is acceptable; however, if interpreted as frequency/severity it is not supported. (Included here only if needed; dependence support exists under 9.3.)
Vyvanse should be avoided in pregnancy.
No pregnancy or pregnancy-avoidance guidance is included in the supplied label excerpts.
Vyvanse should be avoided with a substance use history.
The supplied excerpts discuss assessing risk and monitoring, but do not state an explicit “avoid” directive for substance use history.
Vyvanse should be avoided with uncontrolled hypertension.
No hypertension-specific avoidance instruction is included in the supplied label excerpts.
Weight loss (3–5 kg average) is common with Vyvanse.
No weight loss incidence or magnitude is included in the supplied label excerpts.
Vyvanse should be discontinued if no improvement after 12 weeks.
No discontinuation-after-12-weeks instruction is included in the supplied label excerpts.
Vyvanse should be discontinued if tolerance develops.
The supplied excerpts discuss tolerance (9.3) but do not provide a discontinuation instruction.
Vyvanse commonly causes insomnia.
The supplied excerpts mention insomnia as a potential effect of misuse/abuse (9.2), but do not provide that it “commonly” causes insomnia as a general adverse reaction.
Vyvanse is not for those with heart disease.
No heart disease contraindication is included in the supplied label excerpts.
Vyvanse is not for those with glaucoma.
No glaucoma contraindication is included in the supplied label excerpts.
Vyvanse is not for those with recent MAOI use.
No MAOI-related contraindication or interaction is included in the supplied label excerpts.
Vyvanse can increase heart rate.
Supported (9.2).
Contradictions
Low
AI Statement
Vyvanse should be avoided with recent MAOI use.
Label Reference
No contraindication/avoidance instruction about MAOI use is present in the supplied label excerpts (therefore cannot be assessed as a direct contradiction).
Important Omissions
For a complete on-label evaluation of dosing/administration and safety, the label excerpts provided do not include the official Indications and Usage, Dosage and Administration, Contraindications, Warnings/Precautions beyond abuse/misuse, Adverse Reactions, Drug Interactions, or pregnancy/breastfeeding sections.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Several specific safety-related claims are unsupported due to missing label sections (e.g., pregnancy avoidance, heart disease/glaucoma/MAOI avoidance, and specific discontinuation rules). Some abuse/dependence/control-substance risk statements are supported, but many other statements could mislead if treated as label-accurate.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Needs Review
Primary Issue
Most statements (indication, efficacy trial results, dosing/titration, and multiple contraindication/avoidance and adverse-reaction incidence claims) are not supported by the provided FDA label excerpts.
Suggested Improvement
Restrict claims to what is explicitly present in the provided label text (boxed warning/abuse-misuse, controlled substance, and abuse-related adverse effects/dependence/tolerance). Provide additional official label sections to validate indication, dosing, contraindications, pregnancy guidance, and adverse reaction frequencies.