Poor
Not Aligned
Patient Risk:
Moderate
Summary
Many claims are not verifiable from the supplied labeling excerpts, and several are likely overgeneralized (e.g., “common” side effects and specific QT-risk modifiers). Only limited portions (indication for Huntington’s chorea; depression/suicidality risk and contraindication/monitoring in Section 5.1/4) are supported by the provided label text.
Category Scores
Accurate Statements
Austedo is used to treat chorea associated with Huntington's disease.
Supported by provided label excerpt Section 1 (indications and usage).
Austedo has a potential increased risk of depression.
Supported as Huntington’s patients are at increased risk of depression and AUSTEDO XR/AUSTEDO may increase risk for suicidality (Section 5.1).
Austedo has a potential increased risk of suicidal thoughts or behaviors.
Supported: Section 5.1 states AUSTEDO XR and AUSTEDO may increase the risk for suicidality in patients with Huntington’s disease.
New or worsening depression, suicidal ideation, or unusual mood changes while taking Austedo warrant contacting a doctor immediately.
Supported: Section 5.1 and Section 17 advise observing and reporting new/worsening depression or suicidality promptly; Section 5.1 instructs evaluation immediately for suicidal ideation.
Patients should not stop taking Austedo without consulting their doctor because it could lead to worsening of their condition.
Partially supported at most: Section 5.1 discusses considering discontinuation if depression/suicidality does not resolve, but the provided excerpts do not support the rationale that stopping could worsen the condition.
Unsupported Statements
Austedo is used to treat tardive dyskinesia.
Not supported by the supplied label excerpts (only Huntington’s chorea indication was provided).
Common side effects of Austedo include somnolence.
Not supported by the supplied label excerpts; adverse reaction list content was not provided.
Common side effects of Austedo include dry mouth.
Not supported by the supplied label excerpts.
Common side effects of Austedo include headache.
Not supported by the supplied label excerpts.
Common side effects of Austedo include upper respiratory tract infection.
Not supported by the supplied label excerpts.
Patients may experience insomnia with Austedo.
Not supported by the supplied label excerpts.
Patients may experience anxiety with Austedo.
Not supported by the supplied label excerpts.
Austedo can cause changes in mood.
Not supported as a specific labeled adverse reaction in the supplied excerpts (only depression/unusual mood changes are mentioned in counseling context, without broader “changes in mood” adverse reaction framing).
Austedo can cause nausea.
Not supported by the supplied label excerpts.
Austedo can cause abdominal pain.
Not supported by the supplied label excerpts.
Austedo can cause musculoskeletal discomfort.
Not supported by the supplied label excerpts.
Austedo can cause parkinsonism.
Not supported by the supplied label excerpts.
Parkinsonism symptoms associated with Austedo include tremors.
Not supported by the supplied label excerpts.
Parkinsonism symptoms associated with Austedo include stiffness.
Not supported by the supplied label excerpts.
Parkinsonism symptoms associated with Austedo include slowed movement.
Not supported by the supplied label excerpts.
If parkinsonism symptoms appear or worsen with Austedo, medical attention is recommended.
Not supported by the supplied label excerpts.
Austedo has a risk of QT prolongation.
Not supported by the supplied label excerpts.
The risk of QT prolongation with Austedo is higher in individuals with pre-existing heart conditions.
Not supported by the supplied label excerpts.
The risk of QT prolongation with Austedo is higher in individuals taking other medications that affect the QT interval.
Not supported by the supplied label excerpts.
Allergic reactions are a possible side effect of Austedo.
Not supported by the supplied label excerpts.
A doctor will monitor patients for side effects with Austedo, particularly during the initial weeks of treatment.
Not supported by the supplied label excerpts; provided monitoring language relates to depression/suicidality, not “side effects” broadly or “initial weeks.”
A doctor will monitor patients for side effects with Austedo, particularly after any dosage adjustments.
Not supported by the supplied label excerpts.
Austedo should be taken exactly as prescribed.
Not supported by the supplied label excerpts.
Patients should not stop taking Austedo without consulting their doctor because it could lead to worsening of their condition.
Not supported by the supplied label excerpts; Section 5.1 discusses considering discontinuation if depression/suicidality does not resolve but does not support the provided causality rationale.
Austedo use during pregnancy or breastfeeding carries a potential risk to the fetus or infant.
Not supported by the supplied label excerpts.
Decisions about continuing or starting Austedo during pregnancy or breastfeeding should be made in consultation with a healthcare provider, weighing benefits against potential risks.
Not supported by the supplied label excerpts.
Austedo is manufactured by Teva Pharmaceuticals.
Not supported by the supplied label excerpts.
Contradictions
Low
AI Statement
Austedo is used to treat tardive dyskinesia.
Label Reference
Provided label excerpts only include Huntington’s disease chorea indication; no tardive dyskinesia indication text was supplied, so this is treated as unsupported rather than a direct contradiction.
Important Omissions
For Huntington’s disease risk statement, the label excerpt specifies quantitative trial findings (suicidal ideation 2% treated vs none on placebo; depression 4% treated) and provides specific management language (consider discontinuation if depression/suicidality does not resolve). The AI response did not include these specifics.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
The response includes multiple safety-related claims (e.g., QT prolongation, parkinsonism, depression/suicidality) some of which are not supported by the supplied label excerpts; unsupported safety claims could misinform risk understanding. However, the depression/suicidality risk and related counseling are supported by the provided label text.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Large portion of claims (indications, adverse reactions, QT/interaction modifiers, pregnancy/breastfeeding, monitoring timing, manufacturer) are not supported by the supplied prescribing information excerpts.
Suggested Improvement
Limit claims to the specific on-label text provided (e.g., Huntington’s chorea indication; depression/suicidality risk and related monitoring/counseling and contraindication in suicidal/untreated depression). Remove or qualify all unsupported general adverse effect and risk modifier statements unless the relevant label sections are provided.