Partial
Partially Aligned
Patient Risk:
Moderate
Summary
The evaluation explicitly supports only the dizziness/somnolence-to-driving claim from the label, but the overall provided set of claims includes multiple assertions about alcohol effects, combined risks, and specific clinical scenarios that are not supported by the supplied prescribing information excerpts.
Category Scores
Accurate Statements
LYRICA may cause dizziness and somnolence, which may impair patients’ ability to perform tasks such as driving or operating machinery.
FDA label section 5.5 Dizziness and Somnolence: “LYRICA may cause dizziness and somnolence… Inform patients that LYRICA-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery [see Patient Counseling Information (17)].”
Unsupported Statements
Alcohol can worsen Lyrica’s side effects, especially sleepiness and dizziness; increases risk of impaired thinking; poor coordination; falls; trouble with balance; slow reaction time and impaired driving/coordination; overall impairment even if the person feels okay at first; can raise the chance of excess sedation/unusual drowsiness; alcohol amplifies depressant-like effects of pregabalin.
The supplied FDA label excerpts provided only describe that LYRICA may cause dizziness and somnolence and that these occur more frequently at higher doses, but do not mention alcohol or any specific alcohol-alcohol/pregabalin interaction effects (e.g., impaired thinking, coordination, falls, reaction time, or alcohol amplifying effects).
Some prescribing instructions and clinicians advise avoiding alcohol or limiting it as much as possible while taking pregabalin.
No alcohol counseling or recommendation is present in the supplied prescribing information excerpts.
If a prescriber says limited alcohol may be okay, starting with no alcohol or very small amounts and stopping if feeling more drowsy or dizzy than usual is advised.
No such conditional alcohol guidance is contained in the supplied label text.
Higher doses, new starts, larger amounts of alcohol, or early treatment/adjustment make the combined effects stronger.
The supplied label excerpt states dizziness and somnolence occur more frequently at higher doses of LYRICA, but it does not provide any alcohol-combination statements or timing-specific combined-effect claims.
A history of falls, fainting, or balance problems is a reason to be extra cautious with alcohol while taking Lyrica; needing to drive or use machinery is a reason to be extra cautious with alcohol; other sedating medicines (opioids, benzodiazepines, sleep aids, sedating drugs) increase caution needs with alcohol; sleep apnea/breathing problems increase caution because combining sedating substances can worsen breathing risks.
The supplied excerpts do not include alcohol-related cautions, nor do they provide label text linking alcohol use with falls/fainting/balance, with sedating co-medications, or with sleep apnea/breathing risks.
The safest practical approach is to avoid alcohol while taking Lyrica.
No alcohol-avoidance recommendation is included in the supplied label excerpts.
Severe sleepiness, confusion, trouble staying awake, slow or difficult breathing, or repeated falls after mixing alcohol and Lyrica are indications to seek urgent medical help.
The supplied label excerpts do not describe alcohol-specific warning signs or urgency instructions related to alcohol/pregabalin combination.
Pregabalin has depressant-like effects on the nervous system; alcohol can amplify the depressant-like effects of pregabalin.
The supplied excerpts provided do not use or support these specific 'depressant-like effects' and alcohol-amplification assertions.
Contradictions
Low
AI Statement
Alcohol can worsen Lyrica’s side effects (e.g., dizziness/somnolence) and increase impairment-related outcomes.
Label Reference
Not enough label evidence was provided to establish this as contradicted; no direct contradiction exists in the supplied excerpts.
Important Omissions
For the alcohol-related claims listed, the evaluation does not cite any label section addressing alcohol use or alcohol/pregabalin interactions; without such citations, the claims remain unsupported.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Because multiple statements about alcohol co-use and specific combined-risk outcomes were included without support from the supplied prescribing information excerpts, the risk of inaccurate patient-facing guidance is increased.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Most alcohol-related claims are not supported by the provided FDA label excerpts.
Suggested Improvement
Limit claims to label-supported information from section 5.5 about LYRICA-related dizziness/somnolence and related task impairment, and remove or re-cite any alcohol-specific interaction statements using label text that explicitly addresses alcohol.