Poor
Not Aligned
Patient Risk:
High
Summary
Many claims about alcohol-associated liver injury (including enzyme changes, hepatotoxicity, fibrosis/scarring, liver cancer, and an “FDA study”) are not supported by the provided FDA label excerpts, and the labeling text provided does not establish these alcohol–liver outcomes. Some general therapy/indication claims are only partially aligned because the label excerpt does not include “anxiety disorders” and is limited to the listed indications.
Category Scores
Accurate Statements
Lyrica is an anticonvulsant medication.
Section 1 includes use as adjunctive therapy for partial-onset seizures (adjunctive therapy for partial-onset seizures in patients 1 month of age and older).
Unsupported Statements
Mixing Lyrica with alcohol can increase the risk of liver damage.
Provided label excerpts include no alcohol–liver risk statements or alcohol interaction/hepatotoxicity guidance.
Mixing Lyrica and alcohol can increase the risk of liver inflammation and damage.
No supporting alcohol-related hepatotoxicity/liver inflammation statements in provided excerpts.
Lyrica can increase the levels of certain liver enzymes.
No statement in provided excerpts that pregabalin increases liver enzymes.
Lyrica can cause hepatotoxicity, characterized by liver inflammation and damage.
No hepatotoxicity/detailed liver injury description for LYRICA in provided excerpts.
Alcohol can cause liver inflammation and damage.
The provided FDA label excerpts do not provide alcohol-specific liver inflammation/damage claims in the context of LYRICA.
Alcohol can increase the levels of certain liver enzymes.
No alcohol-specific enzyme claims in the provided FDA label excerpts.
Alcohol can cause liver scarring and fibrosis.
No alcohol-specific liver fibrosis/scarring claims in the provided FDA label excerpts.
Alcohol can increase the risk of liver cancer.
No alcohol-specific liver cancer claims in the provided FDA label excerpts.
An FDA study found that mixing Lyrica and alcohol can increase the risk of liver damage.
No “FDA study” or evidence citation regarding alcohol coadministration appears in provided excerpts.
Patients who took Lyrica and alcohol together were more likely to experience liver damage than those who took Lyrica alone.
No comparative alcohol coadministration outcomes are provided in the supplied excerpts.
Mixing Lyrica and alcohol can significantly increase the risks of liver damage.
No supported alcohol coadministration risk magnitude language in provided excerpts.
Avoid mixing Lyrica and alcohol.
No alcohol-avoidance instruction is present in the provided label excerpts.
Lyrica and alcohol together can increase the risk of liver damage.
No supporting alcohol–liver damage statement in provided excerpts.
Lyrica can cause liver damage by increasing the levels of certain liver enzymes and causing hepatotoxicity.
No label support for pregabalin mechanism involving liver enzyme increases or hepatotoxicity.
Alcohol can cause liver inflammation and damage by increasing the levels of certain liver enzymes, causing liver scarring and fibrosis, and increasing the risk of liver cancer.
No alcohol-related mechanism or liver cancer/fibrosis statements appear in provided label excerpts.
Patients should avoid mixing Lyrica and alcohol altogether.
No alcohol-avoidance language in provided label excerpts.
Women should limit alcohol intake to one drink per day.
No sex-specific alcohol drink-limit guidance appears in provided label excerpts.
Men should limit alcohol intake to two drinks per day.
No sex-specific alcohol drink-limit guidance appears in provided label excerpts.
Regular liver function tests can help detect potential liver damage early.
No monitoring recommendation for liver function tests related to alcohol coadministration is included in provided excerpts.
The symptoms of liver damage can include fatigue, weakness, loss of appetite, nausea and vomiting, and jaundice.
No symptom list for liver damage is present in provided label excerpts.
It is not recommended to take Lyrica and alcohol together.
No alcohol coadministration recommendation appears in the provided excerpts.
Contradictions
High
AI Statement
Lyrica (pregabalin) is a prescription medication used to treat epilepsy, fibromyalgia, and anxiety disorders.
Label Reference
Section 1 lists adjunctive therapy for partial-onset seizures (and does not list “epilepsy” as a broad indication in the provided excerpt) and does not list “anxiety disorders.”
Important Omissions
For any seizure-related claim, the label excerpt specifies “adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older,” rather than a general claim of “epilepsy.”
Importance:
Moderate
The provided label excerpt does not describe or support alcohol-related liver injury risk; therefore, claims implying such risks omit the absence of labeled guidance for alcohol.
Importance:
High
Safety Assessment
Potential Patient Risk:
High
Unsupported and potentially misleading safety claims about alcohol coadministration and liver injury (including liver cancer, fibrosis, and an “FDA study”) are not supported by the provided label excerpts, increasing risk of misinformation.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Major safety claims regarding alcohol–liver injury and an alleged FDA study are not supported by the provided LYRICA prescribing information excerpts; additionally, the indication claim includes “anxiety disorders” which is not listed in the provided Section 1 excerpt.
Suggested Improvement
Remove or rewrite alcohol/liver injury assertions unless supported by the actual label text (including any alcohol/drug interaction section not provided here). Limit indication statements to those listed in Section 1 (e.g., fibromyalgia and partial-onset seizures) and avoid adding “anxiety disorders” unless present in the label.