Partial
Partially Aligned
Patient Risk:
Moderate
Summary
One indication claim (fibromyalgia) aligns with the provided FDA label excerpt. Multiple other claims (epilepsy characterization, anxiety indication, and multiple specific food/juice/caffeine/alcohol interaction and magnitude/mechanism claims) are not supported by the provided label sections and cannot be verified from the supplied label evidence.
Category Scores
Accurate Statements
Lyrica (pregabalin) is a medication prescribed to treat fibromyalgia.
1 INDICATIONS AND USAGE: “Management of fibromyalgia.”
Unsupported Statements
Lyrica (pregabalin) is a medication prescribed to treat epilepsy.
Provided label excerpt specifies adjunctive therapy for partial-onset seizures in patients ≥1 month, not general “epilepsy.”
Lyrica (pregabalin) is a medication prescribed to treat anxiety disorders.
Provided label excerpt lists indications (neuropathic pain conditions, postherpetic neuralgia, partial-onset seizures, fibromyalgia) and does not include anxiety disorders.
Food can impact the absorption and processing of medications.
No provided label section discusses food effects on absorption/processing.
The presence of food in the stomach can alter the absorption of a drug.
No provided label section discusses food altering absorption.
Fatty foods can slow down the absorption of some medications.
No provided label section discusses fatty foods and absorption.
Carbohydrates can speed up the absorption of some medications.
No provided label section discusses carbohydrates and absorption.
Food can affect the absorption of Lyrica.
No provided label section specifically addresses food effects on pregabalin absorption.
Taking Lyrica with a high-fat meal can increase its peak plasma concentration by up to 50%.
No provided label section includes high-fat food effect or Cmax magnitude for pregabalin.
Grapefruit and grapefruit juice can interact with medications including Lyrica.
No provided label section discusses grapefruit interactions for pregabalin.
Consuming grapefruit juice with Lyrica can increase its plasma concentration by up to 30%.
No provided label section includes grapefruit effect magnitude on pregabalin exposure.
Grapefruit contains compounds that inhibit the enzyme responsible for breaking down Lyrica in the liver.
No provided label section supports this grapefruit mechanism; provided interaction excerpt indicates negligible metabolism for pregabalin.
High amounts of caffeine can increase the metabolism of Lyrica, leading to lower levels of the medication in the bloodstream.
No provided label section provides caffeine-specific interaction data; provided label excerpt emphasizes negligible metabolism and unlikely significant PK interactions generally.
Drinking alcohol can slow down the absorption of Lyrica, leading to lower peak plasma concentrations.
No provided label section discusses alcohol effects on pregabalin absorption or exposure.
Fiber-rich foods can slow down the absorption of Lyrica.
No provided label section discusses fiber effects on pregabalin absorption.
Taking Lyrica with a high-fat or high-fiber meal can slow down its absorption.
No provided label section discusses high-fat/high-fiber meal effects on pregabalin absorption.
Avoiding grapefruit and grapefruit juice is recommended for people taking Lyrica.
No provided label section includes grapefruit avoidance recommendations.
High amounts of caffeine can increase the metabolism of Lyrica.
No provided label section supports caffeine-specific metabolic effects for pregabalin.
Contradictions
Important Omissions
No label-supported food/drug interaction details, contraindications, boxed warnings, warnings/precautions, monitoring, or administration instructions were evaluated because the provided label excerpts are limited to indications, pharmacokinetics (general), and a general statement that clinically significant PK interactions are unlikely.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Several claims assert specific interaction effects (grapefruit and caffeine, alcohol, and high-fat meal Cmax magnitude) and a specific mechanism. None of these are supported by the provided label excerpts; inaccurate interaction guidance could mislead risk/avoidance decisions.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Partially Aligned
Primary Issue
Multiple specific food/drug interaction and quantitative mechanism/magnitude claims are not supported by the provided FDA label sections.
Suggested Improvement
Restrict claims to FDA-label-supported indications from the provided excerpt (e.g., fibromyalgia; partial-onset seizures adjunctive therapy) and avoid stating or quantifying grapefruit/caffeine/alcohol/meal effects unless supported by provided label text. Do not assert mechanisms not supported by the label.