Partial
Partially Aligned
Patient Risk:
Medium
Summary
Several scientific/mechanism and side-effect claims are not supported by the provided FDA label excerpts, which only include boxed warning/monitoring and pediatric non-approval for suicidal thoughts and behaviors. Some general claims are plausible but cannot be verified against the limited excerpts.
Category Scores
Accurate Statements
Auvelity can cause serious side effects including suicidal thoughts and behaviors.
Supported in provided excerpts via boxed warning/monitoring language (Boxed Warning; sections 5.1 and 17).
Unsupported Statements
There is currently no generic version of Auvelity (dextromethorphan HBr-bupropion HBr) available.
No label excerpt provided addresses availability of generics.
Auvelity is a prescription medication approved for the treatment of major depressive disorder (MDD) in adults.
No indication text was provided in the supplied label excerpts to verify this claim.
Auvelity combines dextromethorphan and bupropion.
Ingredient information is not provided in the supplied label excerpts; label excerpts focus on suicidal thoughts/behaviors and pediatric use.
Dextromethorphan in Auvelity is an NMDA receptor antagonist.
No mechanism-of-action statements were provided in the supplied label excerpts.
Dextromethorphan in Auvelity is a sigma-1 receptor agonist.
No mechanism-of-action statements were provided in the supplied label excerpts.
Bupropion in Auvelity inhibits the reuptake of norepinephrine and dopamine.
No mechanism-of-action statements were provided in the supplied label excerpts.
Auvelity's dual mechanism involves dextromethorphan and bupropion.
No mechanism-of-action statements were provided in the supplied label excerpts.
Dextromethorphan in Auvelity influences glutamate neurotransmission by acting on NMDA receptors.
No mechanism-of-action statements were provided in the supplied label excerpts.
Dextromethorphan in Auvelity influences glutamate neurotransmission by acting on sigma-1 receptors.
No mechanism-of-action statements were provided in the supplied label excerpts.
Bupropion in Auvelity affects the levels of norepinephrine and dopamine.
No mechanism-of-action statements were provided in the supplied label excerpts.
Norepinephrine and dopamine are implicated in mood regulation.
No discussion of NE/DA in mood regulation was provided in the supplied label excerpts.
Auvelity is associated with common side effects including dizziness.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including somnolence.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including diarrhea.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including nausea.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including vomiting.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including constipation.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including dry mouth.
No adverse reaction list/excerpts were provided.
Auvelity is associated with common side effects including decreased libido.
No adverse reaction list/excerpts were provided.
Auvelity can cause serious side effects including activation of mania or hypomania.
No such warning text was provided in the supplied label excerpts.
Auvelity can cause serious side effects including seizures.
No such warning text was provided in the supplied label excerpts.
Auvelity can cause serious side effects including increased blood pressure.
No such warning text was provided in the supplied label excerpts.
Auvelity is manufactured by Axsome Therapeutics.
No manufacturer/manufactured-by statement was provided in the supplied label excerpts.
Contradictions
Important Omissions
Monitoring/education language specific to suicidal thoughts and behaviors (e.g., close monitoring during initial months and when doses are adjusted; instructing patients/caregivers to report symptoms) was not mentioned.
Importance:
Moderate
Pediatric non-approval and that safety/effectiveness are not established in pediatric patients were not included in the set of claims.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Medium
A boxed-warning-related serious risk (suicidal thoughts/behaviors) was correctly mentioned, but many other serious adverse-effect claims were made without support from the supplied label excerpts. Additionally, key label-directed monitoring/counseling details were omitted.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Most mechanism-of-action and adverse-effect/side-effect assertions are not supported by the provided FDA label excerpts; only suicidal thoughts/behaviors content aligns with the supplied excerpts.
Suggested Improvement
Limit claims to what is present in the provided label excerpts (boxed warning/5.1/17 monitoring and pediatric non-approval), or supply additional FDA label sections (Indications, Dosage/Administration, Warnings/Precautions, Adverse Reactions, and specific sections for mechanisms, manufacturing, and other risks) for accurate evaluation.