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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Teriparatide and Hypercalcaemia: 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.
Teriparatide ↔ Hypercalcaemia
n=551 co-reports · PRR 8.7 · ROR 8.7
Teriparatide, an anabolic parathyroid-hormone analogue, can cause transient hypercalcaemia; 551 co-reports give PRR 8.7. The label advises checking serum calcium and caution in patients with hypercalcaemic disorders.
Regulatory basis: teriparatide (Forteo) prescribing information — transient hypercalcaemia; calcium monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Hours after injection |
| Strength | met | PRR 8.7 with 551 co-reports |
| Consistency | met | Consistent across cohorts |
| Specificity | not established | Hypercalcaemia has many causes |
| Biological gradient | met | Dose-related |
| Plausibility | met | Known PTH-receptor mechanism |
| Coherence | met | Fits teriparatide's calcium effect |
| Experiment | n/a | Often monitored in trials |
| Analogy | met | Analogous to PTH analogue hypercalcaemia |
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 — Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density (NCT00896532)
| Adverse event | BL-Month 12: Placebo QM (n=30) · BL-Month 12: Placebo Q3M (n=20) · BL-Month 12: Alendronate (n=51) · BL-Month12: Teriparatide (n=54) | |||
|---|---|---|---|---|
| Hypercalcaemia | 0/30 | 0/20 | 0/51 | 0/54 |
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 →