Summary
The claims align with fibromyalgia and certain neuropathic-pain indications, and some claim-based drug-interaction statements are contradicted or not supported by the label. Several interactions claims are unsupported or not present in the label, and critical safety/patient-counseling elements appear as omissions per the label.
Category Scores
Accurate Statements
Pregabalin is used to treat fibromyalgia.
Indication 1 includes fibromyalgia.
Pregabalin is used to treat epilepsy.
Partial-onset seizures indication (epilepsy) listed as adjunctive therapy; broader epilepsy language not stated.
Pregabalin is used to treat neuropathic pain.
Indications include diabetic peripheral neuropathy and neuropathic pain; spinal cord injury neuropathic pain also listed.
Unsupported Statements
Lyrica can interact with a wide range of medications.
Label section 7 indicates no significant pharmacokinetic interactions with several antiepileptic drugs; general statement about wide-range interactions is not supported.
Lyrica can interact with other medications in several ways, including pharmacokinetic interactions.
Label content indicates negligible metabolism and unlikely pharmacokinetic interactions; pharmacokinetic interactions are not supported.
Lyrica can interact with other medications in several ways, including pharmacodynamic interactions.
Pharmacodynamic interaction information is not provided in the label.
Carbamazepine can increase the risk of side effects when taken with Lyrica.
Not present in label; interactions with carbamazepine are not described as increasing risk.
Phenytoin can increase the risk of side effects when taken with Lyrica.
Not present in label; interactions with phenytoin are not described as increasing risk.
Valproate can increase the risk of side effects when taken with Lyrica.
Not present in label; no described risk increase with valproate.
Fluoxetine can increase the risk of serotonin syndrome when taken with Lyrica.
Serotonin syndrome risk with Lyrica and antidepressants is not described in label.
Sertraline can increase the risk of serotonin syndrome when taken with Lyrica.
Serotonin syndrome interaction not described in label.
Diphenhydramine can increase the risk of drowsiness and other side effects when taken with Lyrica.
Not described in label; no explicit diurnal sedation interaction stated.
Fexofenadine can increase the risk of drowsiness and other side effects when taken with Lyrica.
Not described in label.
Alprazolam can increase the risk of sedation and respiratory depression when taken with Lyrica.
Not described in label.
Clonazepam can increase the risk of sedation and respiratory depression when taken with Lyrica.
Not described in label.
Lyrica can affect the way other medications are absorbed, distributed, metabolized, or excreted in the body.
Label states negligible metabolism and unlikely pharmacokinetic interactions; this statement is contradicted.
Lyrica can affect the way other medications work in the body, leading to increased or decreased effects.
Not described in label; pharmacodynamic interactions are not established in label content.
The risk of serotonin syndrome when taking Lyrica with other medications.
Not described in label as a risk.
Sedation and respiratory depression can occur when taking Lyrica with other medications.
Not described in label as a combined-sedation risk with other meds.
Lyrica can increase the risk of dizziness when taken with other medications.
Not described in label.
Lyrica can increase the risk of drowsiness when taken with other medications.
Not described in label.
Lyrica can increase the risk of nausea when taken with other medications.
Not described in label.
Inform your doctor about all the medications you're currently taking, including prescription and OTC medications, vitamins, and supplements.
Not present in label 17; counseling language provided is different.
Contradictions
Low
AI Statement
Lyrica can interact with a wide range of medications.
Label Reference
7
Low
AI Statement
Lyrica can interact with other medications in several ways, including pharmacokinetic interactions.
Label Reference
7
Low
AI Statement
Lyrica can affect the way other medications are absorbed, distributed, metabolized, or excreted in the body.
Label Reference
7
Important Omissions
Boxed warning for suicidality
Importance:
Moderate
Pregnancy risk and fetal considerations (8.1)
Importance:
Moderate
Pediatric safety (8.4)
Importance:
Moderate
Dosing safety and renal impairment adjustments (2)
Importance:
Moderate
Medication Guide / patient counseling availability (17)
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
Assessment reflects that most issues are either not supported by label or are contradicted; however, several safety-critical items (boxed warnings, pregnancy, pediatric safety, dosing safety) are omissions.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Missing boxed warnings and key safety/patient-counseling items; several interaction claims are not supported by the label.
Suggested Improvement
Limit claims to those supported by the labeling; add/verify boxed-warning content (suicidality), pregnancy, pediatric safety, renal-dosing considerations, and patient counseling material (Medication Guide) per the label.