Good
Mostly Aligned
Patient Risk:
Moderate
Summary
Most discontinuation-related symptom claims and the recommendation to taper are supported by the provided LYRICA labeling excerpt (5.6). Several items (e.g., specific symptom-to-rapid-discontinuation timing, “empeoramiento marcado” phrasing, “mareo intenso o desmayo” triage wording, and claims about depression/suicidality being prioritized) are not directly supported verbatim by the supplied excerpts. Mechanism-of-action claim is partially supported via binding to the nervous system target (12.1).
Category Scores
Accurate Statements
Suspender Lyrica (pregabalina) de forma brusca puede causar síntomas de retirada.
2.1/5.6: “Following abrupt or rapid discontinuation of LYRICA, some patients reported symptoms including…” and “If LYRICA is discontinued, taper…rather than discontinue…abruptly.”
Suspender la pregabalina de golpe puede desencadenar síntomas de retirada.
5.6: “Following abrupt or rapid discontinuation of LYRICA, some patients reported symptoms…”
La forma recomendada suele ser reducir la pregabalina gradualmente bajo indicación médica.
2.1/5.6: “When discontinuing LYRICA, taper gradually over a minimum of 1 week rather than discontinue…abruptly.”
La velocidad de descenso al reducir pregabalina debería ajustarse según la dosis y la respuesta.
Parcial/indirecto: La sección 5.6 indica que se reduzca gradualmente sobre un mínimo de 1 semana, pero los detalles sobre ajuste por dosis y respuesta no aparecen en los extractos provistos.
Al dejar Lyrica de golpe pueden aparecer ansiedad.
5.6: “some patients reported symptoms including… anxiety …”
Al dejar Lyrica de golpe pueden aparecer irritabilidad.
Unsupported by provided excerpts (not listed in 5.6 excerpt).
Al dejar Lyrica de golpe pueden aparecer inquietud.
Unsupported by provided excerpts (not listed in 5.6 excerpt).
Al dejar Lyrica de golpe pueden aparecer insomnio o problemas para dormir.
5.6: “symptoms including insomnia…”
Al dejar Lyrica de golpe puede aparecer mareo.
5.6 excerpt does not list dizziness in the discontinuation-symptom list; however “Dizziness and Somnolence” is listed as a serious adverse reaction category elsewhere in labeling (6.1). No direct tie to abrupt discontinuation in the provided excerpt.
Al dejar Lyrica de golpe pueden aparecer náuseas.
5.6: “… nausea …”
Al dejar Lyrica de golpe puede aparecer malestar gastrointestinal.
Indirect/partially supported: 5.6 lists “nausea” and “diarrhea,” but not the broader phrase “malestar gastrointestinal.”
Al dejar Lyrica de golpe puede aparecer sudoración.
5.6: “… hyperhidrosis …” (sudoración).
Al dejar Lyrica de golpe puede aparecer temblor.
Unsupported by provided excerpts (not listed in 5.6).
Al dejar Lyrica de golpe puede aparecer dolor de cabeza.
5.6: “… headache …”
Al dejar Lyrica de golpe puede aparecer diarrea.
5.6: “… diarrhea.”
Al suspender pregabalina, se debe buscar atención médica prioritaria si aparecen ideas de autolesión o cambios severos del estado de ánimo.
Unsupported by provided excerpts: while 6.1 lists “Suicidal Behavior and Ideation [see 5.3],” the specific “priority” guidance and discontinuation-triggered triage wording are not included in the supplied text.
Al reducir pregabalina, el médico puede proponer un plan para mantener el control del dolor o de la causa original.
Supported only at a general level by the instruction to taper; the specific “plan to maintain control” wording is not present in the supplied excerpts.
El plan para reducir pregabalina puede incluir otros medicamentos o ajustes no farmacológicos.
Unsupported by provided excerpts.
El plan de reducción gradual de pregabalina suele formar parte del manejo para mantener el control del dolor o de la causa original.
Partially supported only by the rationale to taper rather than abrupt discontinuation; specific “suele formar parte” and “mantener el control” are not in supplied text.
Unsupported Statements
Al dejar Lyrica de golpe pueden aparecer irritabilidad.
The provided 5.6 symptom list does not include “irritability.”
Al dejar Lyrica de golpe pueden aparecer inquietud.
The provided 5.6 symptom list does not include “inquietud.”
Al dejar Lyrica de golpe puede aparecer mareo intenso o desmayo.
Although dizziness is referenced generally in 6.1 (“Dizziness and Somnolence”), the specific combination “mareo intenso o desmayo” as a discontinuation-related symptom requiring prioritized urgent attention is not present in the supplied excerpts.
Al dejar Lyrica de golpe puede aparecer mareo.
“Dizziness” is not listed in the abrupt discontinuation symptom list in 5.6 excerpts.
Al dejar Lyrica de golpe puede aparecer malestar gastrointestinal.
The 5.6 excerpt lists specific GI symptoms (nausea, diarrhea) but does not support the broader phrase “malestar gastrointestinal.”
Al dejar Lyrica de golpe puede aparecer temblor.
Not included in the provided 5.6 symptom list.
Al dejar Lyrica de golpe puede aparecer dificultad para concentrarse.
Not included in the provided 5.6 symptom list.
En algunos casos, al dejar Lyrica de golpe puede ocurrir un empeoramiento marcado del dolor.
5.6 excerpt provided does not mention pain worsening intensity or frequency wording.
Los síntomas de retirada pueden sentirse de forma relativamente rápida después de reducir o suspender pregabalina, especialmente si fue de manera repentina.
No timing language is present in the provided 5.6 excerpt.
Si la pregabalina se usaba para dolor neuropático, al suspenderla puede ocurrir regreso del dolor.
Not stated in provided excerpts.
Si la pregabalina se usaba para dolor neuropático, el regreso del dolor puede ser a veces más fuerte que antes.
Not stated in provided excerpts.
Si la pregabalina se usaba como parte del tratamiento anticonvulsivo, al suspenderla puede ocurrir empeoramiento del control de crisis.
5.6 mentions minimizing increased seizure frequency in seizure disorders, but the claim about worsening control of seizures upon discontinuation in that specific phrasing is not directly supported by provided excerpt.
La retirada y el regreso/empeoramiento de la condición tratada pueden coexistir.
Not stated in provided excerpts.
La pregabalina actúa sobre el sistema nervioso.
12.1 excerpt indicates binding to the alpha2-delta site, but the provided excerpt does not explicitly state “acts on the nervous system.”
Al suspender pregabalina, se debe buscar atención médica prioritaria si aparece confusión marcada.
Not present in provided excerpts.
Al suspender pregabalina, se debe buscar atención médica prioritaria si ocurre un empeoramiento rápido y severo del dolor.
Not present in provided excerpts.
No hay una única duración para los síntomas de retirada tras suspender o ajustar pregabalina.
No duration variability statement is present in provided excerpts.
Los síntomas de retirada pueden mejorar con el tiempo tras suspender o ajustar el tratamiento con pregabalina.
No explicit improvement-with-time statement is present in provided excerpts.
La rapidez y la intensidad de los síntomas de retirada dependen de la dosis, del tiempo de uso y del ritmo de reducción.
Not stated in provided excerpts.
Contradictions
Important Omissions
The label excerpt specifies taper over a minimum of 1 week; the response does not mention the “minimum of 1 week” requirement.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Most abrupt-discontinuation symptoms listed in 5.6 (insomnia, nausea, headache, anxiety, hyperhidrosis, diarrhea) are supported. However, multiple additional symptoms and timing claims are not supported by the provided label excerpts, and several urgent-care triage instructions (e.g., suicidality/marked confusion) are not supported by the supplied text, which could lead to over- or mis-weighting of symptom guidance. The absence of the explicit “minimum of 1 week” taper instruction is also a material omission for safe discontinuation messaging.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Mostly Aligned
Primary Issue
Several discontinuation-related symptom/timing/urgency statements are not supported by the provided labeling excerpts, and the response omits the label’s explicit “taper gradually over a minimum of 1 week” instruction.
Suggested Improvement
Limit discontinuation claims to the specific symptoms listed in 5.6 excerpt (insomnia, nausea, headache, anxiety, hyperhidrosis, diarrhea) and explicitly state taper gradually over a minimum of 1 week; avoid adding unsupported symptoms (e.g., irritability, tremor, concentration difficulty) and avoid unsupported urgent triage instructions not present in the provided excerpts.