Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Several safety-related statements (dizziness/somnolence, driving/operating machinery, additive cognitive/gross motor effects with CNS depressants) are consistent with the label excerpts, but multiple specific details are not supported by the provided label text (e.g., timing/course of symptoms, “sleep feel/bedtime habits,” “worst when medication level is rising,” and specific fall-prevention guidance like standing up slowly). There is also a missing label-grounded monitoring/urgent evaluation basis for some serious-symptom advice.
Category Scores
Accurate Statements
Lyrica can affect alertness and physical coordination.
Label excerpt 5.5 states dizziness and somnolence may impair ability to perform tasks such as driving or operating machinery; label excerpt 7 states additive effects on cognitive and gross motor functioning when co-administered with oxycodone, lorazepam, or ethanol.
The most common day-to-day impacts of Lyrica include feeling sleepy or less mentally sharp.
Label excerpt 5.5 includes somnolence; label excerpt 6.1 indicates dizziness and somnolence and reports of 'thinking abnormal' more commonly in controlled trials.
Lyrica can cause dizziness and balance issues.
Label excerpt 5.5: dizziness; label excerpt 7: additive effects on gross motor functioning; no explicit 'balance' term is in excerpts but dizziness and gross motor impairment are aligned.
Lyrica may require delaying driving until the patient knows how they react to first doses and any dose increases.
Label excerpt 5.5: dizziness/somnolence may impair ability to perform tasks such as driving or operating machinery; label excerpt text provided does not mention 'first doses and any dose increases,' but the general driving caution is label-supported.
Lyrica requires caution with operating machinery or tasks where a lapse in attention matters.
Label excerpt 5.5: dizziness and somnolence may impair ability to perform tasks such as driving or operating machinery.
Lyrica can cause drowsiness, dizziness, and slowed reaction time in some people.
Label excerpt 5.5: dizziness and somnolence; label excerpt 7: additive cognitive/gross motor effects; 'slowed reaction time' is not explicit but is consistent with impairment language.
Lyrica can change bedtime habits and sleep feel, for example by making people more sleepy in the evening.
Label excerpts provided do not address bedtime or timing of sleepiness; somnolence is supported, but the bedtime routine claim is not.
Lyrica can cause dizziness, and standing up slowly if dizziness happens is recommended to reduce fall risk.
Label excerpt 5.5 supports dizziness/somnolence impairing task performance, but the specific instruction about standing up slowly to reduce fall risk is not included in the provided label excerpts.
Mixing Lyrica with other substances that increase sedation (e.g., alcohol or other sedating medicines) without checking with a clinician can worsen drowsiness.
Label excerpt 5.4: respiratory depression associated when co-administered with CNS depressants including opioids; label excerpt 7: additive effects on cognitive and gross motor functioning when co-administered with ethanol (and oxycodone/lorazepam) despite no PK interactions. The label does not specifically use the phrasing 'worsen drowsiness,' but additive cognitive/gross motor effects with CNS depressants are supported.
Severe or persistent dizziness, fainting, or unusual reactions warrant contacting a prescriber promptly.
Label excerpts provided include instructions to inform physicians about dizziness/somnolence-related functional impairment (5.5), and discontinue with hypersensitivity/angioedema symptoms (5.1/5.2), but there is no explicit label instruction about fainting or 'persistent dizziness' threshold for 'promptly contact prescriber.'
Unsupported Statements
The most common day-to-day impacts of Lyrica include feeling sleepy or less mentally sharp.
The label excerpt supports somnolence and 'thinking abnormal' more commonly, but it does not support the 'most common day-to-day impacts' framing as a direct Medication Guide/label claim.
Dizziness and balance issues from Lyrica can be worst at the beginning of treatment or after a dose change.
Provided label excerpts do not state that dizziness/somnolence are worst at initiation or after dose changes.
Some people need to plan around when Lyrica side effects are strongest, often after a dose.
No support in provided label excerpts regarding peak timing after dosing.
Lyrica can cause sleepiness that may change bedtime or morning routines.
No label excerpt about bedtime or morning routine changes.
The effects of Lyrica can be most noticeable in the first days to weeks as the body adjusts.
No support in the provided label excerpts regarding onset timeline for noticing effects.
Daytime sedation or dizziness from Lyrica can be worst when the medication level is rising, often after dosing.
No support in the provided label excerpts for a relationship between symptom severity and medication levels rising/after dosing.
Lyrica can be taken on a schedule, commonly once or multiple times daily depending on the prescribed regimen.
Label excerpt 2.4 specifies divided doses (two or three) for partial-onset seizures, but the 'commonly once or multiple times daily' statement is not supported by the provided excerpts.
Lyrica can cause unsteadiness that may make high-risk activities (e.g., certain exercise or jobs on ladders) unsafe for some people.
The label excerpt 5.5 addresses driving/operating machinery; it does not specifically mention unsteadiness, ladders, or exercise.
Lyrica can change bedtime habits and sleep feel, for example by making people more sleepy in the evening.
No support in the provided label excerpts.
Lyrica is associated with increased appetite or weight gain in some people.
Label excerpt supports weight gain may occur (5.8), but the provided excerpts do not explicitly state increased appetite.
Increased appetite or weight gain from Lyrica can affect daily habits.
The label excerpts do not include this behavioral framing.
Some people may feel more tired rather than more hungry while on Lyrica.
The provided excerpts do not discuss tiredness as an alternative to hunger.
Lyrica can affect thinking and alertness, including drowsiness or feeling mentally slowed.
Label excerpt supports dizziness/somnolence and 'thinking abnormal' but does not explicitly describe 'mentally slowed' wording or 'including drowsiness' as phrased.
Concentration problems from Lyrica can interfere with safety or performance.
The label supports impairment for driving/operating machinery; it does not explicitly mention concentration problems.
Be extra cautious with driving and hazardous tasks after starting or increasing the dose of Lyrica.
Label excerpt 5.5 does not mention starting/increasing dose timing.
Lyrica can cause dizziness, and standing up slowly if dizziness happens is recommended to reduce fall risk.
No specific instruction about standing slowly or fall-risk mitigation is present in provided excerpts.
Severe or persistent dizziness, fainting, or unusual reactions warrant contacting a prescriber promptly.
No explicit label guidance about fainting or thresholds for 'promptly' contacting prescriber in the provided excerpts.
Seek urgent medical advice for serious side effects such as severe sleepiness, trouble breathing, or signs of an allergic reaction from Lyrica.
Trouble breathing is related to respiratory depression (5.4), and allergic reactions/angioedema/hypersensitivity lead to discontinuation (5.1/5.2), but the provided excerpts do not explicitly instruct 'urgent medical advice' for 'severe sleepiness' or provide a direct urgency instruction.
Serious side effects such as trouble breathing and allergic reaction are uncommon but important.
Label excerpts provided include respiratory depression severity and hypersensitivity/angioedema that can be life-threatening, but they do not state 'uncommon' for these events.
Contradictions
Important Omissions
The label excerpt includes specific contraindication information (hypersensitivity) and specific discontinuation instructions for angioedema/hypersensitivity symptoms, plus suicidal behavior monitoring and respiratory depression monitoring/considerations with CNS depressants and underlying respiratory impairment; these topics were not addressed in the AI statements.
Importance:
Moderate
Dose tapering/discontinuation instructions (taper gradually over at least 1 week) are not mentioned.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
General counseling about dizziness/somnolence and driving/operating machinery aligns with the label, but several specific timing/peak-effect/fall-risk instructions are unsupported, and urgent-care guidance and omissions of label-required monitoring/discontinuation points could reduce labeling fidelity.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Partially Aligned
Primary Issue
Several detailed temporal/behavioral claims are not supported by the provided label excerpts (peak timing, bedtime routine changes, 'standing up slowly' fall-risk advice, and 'uncommon' event frequency), and some label-required precautions/monitoring (suicidal behavior, respiratory depression monitoring guidance, discontinuation/tapering, and specific hypersensitivity/angioedema instructions) are omitted.
Suggested Improvement
Rephrase to rely strictly on label-supported points in the provided excerpts: dizziness/somnolence impair driving/operating machinery; additive cognitive/gross motor effects with CNS depressants (including ethanol); respiratory depression monitoring when co-prescribed with CNS depressants/respiratory impairment; discontinuation instructions for hypersensitivity/angioedema symptoms; and taper gradually/discontinuation guidance.