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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Cinacalcet and Hypocalcaemia: 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.
Cinacalcet ↔ Hypocalcaemia
n=273 co-reports · PRR 65.8 · ROR 69.8
Cinacalcet lowers parathyroid hormone by acting on the calcium-sensing receptor, and because it suppresses parathyroid hormone it also lowers serum calcium — so hypocalcaemia is a direct, dose-related consequence of how the drug works. It is the reason calcium levels are monitored when therapy starts or the dose changes, and why active vitamin D is sometimes needed. The 273 co-reports (PRR 65.8) reflect the drug's use in dialysis patients with secondary hyperparathyroidism, who are already at risk of calcium disturbance.
Regulatory basis: cinacalcet prescribing information (hypocalcaemia warning; calcium monitoring).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Calcium falls during treatment and recovers with dose adjustment or withdrawal |
| Strength | met | Very high PRR, consistent with a drug whose whole action lowers PTH and calcium |
| Consistency | met | Reproduced across the cinacalcet trial programme |
| Specificity | met | A direct consequence of the drug's calcimimetic mechanism |
| Biological gradient | met | Dose-related |
| Plausibility | met | Calcium-sensing-receptor activation suppresses PTH and lowers calcium |
| Coherence | met | Coheres with the labelled calcium-monitoring guidance |
| Experiment | met | Randomized trials measured calcium by arm |
| Analogy | met | Analogous to hypocalcaemia from other calcimimetics |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for cinacalcet captured hypocalcaemia as a coded event; calcium changes are captured through routine laboratory monitoring rather than coded trial endpoints.