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Causality assessment · Causality: well established

Meperidine and Convulsion: is the FAERS signal real?

n=77 co-reports · PRR 3.0 · ROR 3.1
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Causality: well established

Meperidine ↔ Convulsion

n=77 co-reports · PRR 3.0 · ROR 3.1

Meperidine is an opioid analgesic; its metabolite normeperidine accumulates, especially in renal impairment or with repeated dosing, and is a central nervous system excitant that causes tremor, myoclonus, and seizures (77 co-reports, PRR 3.0). This distinctive neurotoxicity is why meperidine is avoided in renal failure and in patients taking MAOIs.

Regulatory basis: meperidine prescribing information — normeperidine neurotoxicity/seizures; contraindicated with MAOIs.

Bradford Hill viewpointStatusNote
Temporality (necessary)metSeizures with drug accumulation
StrengthmetPRR 3.0, modest
ConsistencymetReproduced across case series
SpecificitymetFairly specific to meperidine
Biological gradientmetWorse with higher doses or renal impairment
PlausibilitymetNormeperidine CNS excitation
CoherencemetFits the pharmacology
Experimentn/aNot a trial endpoint
AnalogymetAnalogous to other metabolite-driven neurotoxicity

This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.

✓ Trial evidence found — E7 TCR T Cells for Human Papillomavirus-Associated Cancers (NCT02858310)

Adverse eventPhase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells (n=3) · Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells (n=3) · Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells (n=6) · Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells (n=18)
Seizure0/30/30/61/18

Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →