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Causality: well established
Causality assessment · Causality: well established
Corticosteroids (prednisolone) and Avascular necrosis of bone: 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.
Corticosteroids (prednisolone) ↔ Avascular necrosis of bone
n=1,064 co-reports · PRR 3.8 · ROR 3.9
Systemic corticosteroids such as prednisolone are a leading cause of osteonecrosis (avascular necrosis), especially of the hip, and the risk rises with higher doses and longer courses — even short high-dose bursts have been implicated. The mechanism involves impaired blood supply and altered fat metabolism in bone. The 1,064 co-reports (PRR 3.8) are driven by the enormous number of patients who receive steroids for inflammatory and autoimmune conditions.
Regulatory basis: corticosteroid prescribing information (osteonecrosis, osteoporosis; monitoring advice). Established glucocorticoid-osteonecrosis literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Osteonecrosis typically appears months after starting or escalating steroids |
| Strength | partial | PRR 4 with a large co-report count — a modest but broad signal |
| Consistency | met | Reproduced across decades of cohort and case series |
| Specificity | met | A recognised corticosteroid effect, not unique to prednisolone |
| Biological gradient | partial | Dose- and duration-related |
| Plausibility | met | Impaired bone blood supply and fat-metabolism changes are the mechanisms |
| Coherence | met | Coheres with the labelled skeletal warnings and monitoring |
| Experiment | partial | Dechallenge (steroid withdrawal) does not reverse established lesions; no randomized trial |
| Analogy | met | Analogous to osteonecrosis from other glucocorticoids and in transplant/immunosuppression |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for prednisolone captured osteonecrosis; it appears months after steroid exposure and is identified through imaging and cohort studies rather than a trial AE table.