← All causality assessments
Causality: well established
Causality assessment · Causality: well established
Tenofovir Disoproxil Fumarate and Bone Density Decreased: is the FAERS signal real?
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.
Tenofovir Disoproxil Fumarate ↔ Bone Density Decreased
n=10,686 co-reports · PRR 326.5 · ROR 483.4
Entecavir is a nucleoside analogue (NRTI) for hepatitis B. Drug resistance is the expected consequence of selective pressure: HBV polymerase mutations reduce drug binding. 59 co-reports (PRR 30.8) reflect HBV-treated populations. Resistance is a known class effect of NRTIs.
HBV resistance literature: Hepatology 2017, PMID: 27367463.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in virology literature |
| Strength | met | PRR 30.8 with 59 co-reports |
| Consistency | met | Reproduced across NRTI class |
| Specificity | partial | Specific to reverse transcriptase inhibitors |
| Biological gradient | met | Resistance increases with monotherapy |
| Plausibility | met | Known polymerase mutation mechanism |
| Coherence | met | Coherent with viral evolution |
| Experiment | n/a | Measured in virology studies |
| Analogy | met | Other NRTIs show cross-class resistance |
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 Tenofovir captured bone density decreased as a tracked adverse event in a usable structure. Drug resistance is measured in virologic studies, not RCT AE tables.