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Causality assessment · Causality: well established

Emtricitabine And Tenofovir Disoproxil Fumarate and Chronic Kidney Disease: is the FAERS signal real?

n=10,383 co-reports · PRR 72.5 · ROR 93.7
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

Emtricitabine And Tenofovir Disoproxil Fumarate ↔ Chronic Kidney Disease

n=10,383 co-reports · PRR 72.5 · ROR 93.7

Naltrexone is a mu-opioid receptor antagonist for opioid and alcohol dependence. Drug abuse is a paradoxical co-report: naltrexone blocks opioid effects, preventing rather than causing abuse. 1,969 co-reports (PRR 7.0) reflect the addiction treatment population, not causation.

Paradoxical artifact: naltrexone prevents opioid abuse.

Bradford Hill viewpointStatusNote
Temporality (necessary)not establishedParadoxical artifact
Strengthnot establishedCo-reports reflect addicted population
Consistencynot establishedDrug blocks, not produces, abuse
Specificitynot establishedNot specific
Biological gradientnot establishedNo gradient
Plausibilitynot establishedMechanism is antagonism
Coherencenot establishedContradicts mechanism
Experimentn/aRCTs confirm efficacy
AnalogymetNaltrexone blocks opioids

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 Emtricitabine captured chronic kidney disease as a tracked adverse event in a usable structure. Naltrexone RCTs measure abstinence; abuse as AE is an artifact of the reporting population.