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Causality assessment · Expected pharmacological effect

Escitslopram and Suicidal Ideation: is the FAERS signal real?

n=1,320 co-reports · PRR 5.3 · ROR 5.4
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.
Expected pharmacological effect

Escitslopram ↔ Suicidal Ideation

n=1,320 co-reports · PRR 5.3 · ROR 5.4

Tozinameran (Pfizer/BioNTech COVID-19 vaccine) is an mRNA vaccine encoding the SARS-CoV-2 spike protein. Co-reporting of COVID-19 as a reaction is an artifact: vaccinated individuals can have breakthrough infections recorded as AEs, but the vaccine prevents, not causes, COVID-19. 154,725 co-reports (PRR 3.2) in enormous vaccinated cohort.

Coding artifact: breakthrough infections recorded as AEs in massive vaccinated population.

Bradford Hill viewpointStatusNote
Temporality (necessary)not establishedBreakthrough infection artifact
Strengthnot establishedPRR 3.2 reflects enormous population
Consistencynot establishedVaccine prevents, not causes, COVID-19
Specificitynot establishedNot specific
Biological gradientnot establishedNo gradient
Plausibilitynot establishedNo mechanism for causing disease
Coherencenot establishedContradicts vaccine mechanism
ExperimentmetRCT confirms 94 % efficacy
Analogynot establishedN/A

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.

✗ No ClinicalTrials.gov results-posting trial in the top search hits for Escitslopram captured suicidal ideation as a tracked adverse event in a usable structure. The pivotal RCT (NCT04368728) tracked COVID-19 as primary endpoint; 94 % efficacy confirmed.