Good
Mostly Aligned
Patient Risk:
Moderate
Summary
Overall good alignment with FDA label: core indications (epilepsy/partial seizures, fibromyalgia, neuropathic pain) and key adverse events (dizziness, somnolence, weight gain, fatigue, headache) are supported. Several sleep-disturbance related claims and other safety details (boxed warnings, pregnancy, pediatric safety, and explicit drug-class designation) are not fully supported by the provided label content.
Category Scores
Accurate Statements
Lyrica (pregabalin) is a prescription medication commonly prescribed to treat epilepsy, fibromyalgia, and neuropathic pain.
Sections 2.4, 2.5, 2.2, 2.3
Lyrica works by affecting the way that nerves send messages to the brain.
Section 12.1
Lyrica can help to reduce the frequency and severity of seizures.
Section 2.4
Lyrica can alleviate symptoms of fibromyalgia.
Section 2.5
Lyrica can alleviate symptoms of neuropathic pain.
Sections 2.2, 2.3
Lyrica is used to treat epilepsy, fibromyalgia, and neuropathic pain.
Sections 2.4, 2.5, 2.2, 2.3
Dizziness (22.8%).
Section 6.1
Drowsiness (20.4%).
Section 6.1
Weight gain (15.4%).
Section 6.1
Fatigue (13.4%).
Section 6.1
Headache (12.4%).
Section 6.1
Unsupported Statements
Lyrica is a prescription medication that belongs to a class of drugs called gabapentinoids.
The label does not state the class Gabapentinoids.
Contradictions
Important Omissions
Boxed warning for suicidality is not addressed in the claims.
Importance:
High
Contraindications (e.g., hypersensitivity) are not addressed.
Importance:
High
Pregnancy risk (Pregnancy Category C; 8.1) not addressed.
Importance:
High
Pediatric safety and age-specific dosing not addressed beyond mechanism claim.
Importance:
Moderate
Dosing safety details (renal impairment dosing and titration) not addressed.
Importance:
High
Safety Assessment
Potential Patient Risk:
Moderate
Label includes several clinically important adverse events (e.g., dizziness, somnolence, edema, weight gain) and a boxed warning for suicidality, but many sleep-related claims are not explicitly listed; overall safety concerns exist with dose-dependent effects and special populations (renal impairment, pediatric use) not addressed in the claims.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Missing safety elements (boxed warnings, contraindications, pregnancy, pediatric safety) and some label-specific dosing considerations in the evaluated claims.
Suggested Improvement
Incorporate explicit boxed warning language (suicidality), contraindications (hypersensitivity), pregnancy considerations (category C), and pediatric safety/dosing guidance; ensure sleep-related effects are accurately represented if claimed.