Partial
Partially Aligned
Patient Risk:
Info
Summary
The claims broadly describe cognitive impairment as a side effect and discuss mechanism, but the provided FDA label excerpts do not support cognition/memory impairment content (e.g., “thinking abnormal” is present yet not equivalent to memory impairment). Multiple claims about timing and specific mechanistic receptor explanation are unsupported by the supplied label text.
Category Scores
Accurate Statements
The FDA label includes a cognitive/mental functioning-related adverse reaction term: “thinking abnormal.”
Label 6.1: “Most common adverse reactions … and ‘thinking abnormal’ …”
Unsupported Statements
Prolonged use of Lyrica (pregabalin) has been associated with cognitive impairment, particularly memory.
The supplied label excerpts do not mention cognitive impairment or memory, nor do they establish an association specifically with prolonged use.
Lyrica works by modulating the activity of neurotransmitters in the brain.
The supplied label excerpt on mechanism (12.1) describes binding to the alpha2-delta site and involvement in anti-nociceptive/antiseizure effects; it does not state modulation of neurotransmitters.
Lyrica can cause side effects including changes in cognitive function.
While “thinking abnormal” is included, the label excerpts do not support a general statement about cognitive function changes.
Pregabalin may interfere with memory formation and retrieval.
No memory-specific statement is present in the supplied label excerpts.
Pregabalin may cause difficulties in learning and retaining new information.
No learning/retaining new information statement is present in the supplied label excerpts.
A study in Neuropsychopharmacology found that long-term use of pregabalin at doses similar to clinical settings impaired memory performance in healthy participants.
The supplied FDA label excerpts do not reference this study or provide these study-specific outcomes.
The researchers suggested that pregabalin-related memory impairment may be due to effects on GABA receptors.
The supplied label excerpt on mechanism (12.1) does not mention GABA receptors.
Pregabalin for epilepsy or neuropathic pain can cause cognitive side effects, including memory problems.
The supplied label excerpts do not include memory/cognitive side effects content.
In patients taking pregabalin for epilepsy or neuropathic pain, the severity and frequency of cognitive side effects including memory problems vary widely.
No memory/cognitive severity/frequency characterization is provided in the supplied label excerpts.
The FDA labeling for pregabalin includes cognitive impairment, including memory problems, as a potential side effect.
The supplied label excerpts do not list cognitive impairment or memory problems as adverse reactions.
The FDA labeling states that pregabalin-associated cognitive impairment, including memory problems, may occur at any time during treatment.
No timing statement about cognitive impairment/memory is present in the supplied label excerpts.
Not everyone taking Lyrica will experience memory problems.
No memory-problem adverse reaction is supported by the supplied label excerpts.
The severity of Lyrica-related cognitive side effects, including memory problems, can vary depending on the individual and treatment duration.
No memory/cognitive side effect severity tied to individual/treatment duration is present in the supplied label excerpts.
Contradictions
Important Omissions
If the intent is to substantiate cognitive impairment, the label excerpt provided only supports “thinking abnormal” among common adverse reactions and does not provide memory-specific substantiation. A label-accurate response would need to avoid claiming memory impairment or provide supported label language.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Info
The claims overreach beyond the provided label excerpts (memory/cognitive impairment, receptor mechanism, timing), which could misinform risk characterization. However, no dosing or direct patient management instructions contradict the label in the provided claims.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Memory/cognitive impairment and timing claims are not supported by the supplied prescribing information excerpts; mechanism claim does not match the label’s alpha2-delta binding description.
Suggested Improvement
Limit safety statements to on-label language provided (e.g., “thinking abnormal”) and avoid memory-specific and neurotransmitter/GABA-receptor mechanistic claims unless the provided FDA label excerpts explicitly support them.