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Causality: well established
Causality assessment · Causality: well established
Ecallantide and Hereditary Angioedema: 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.
Ecallantide ↔ Hereditary Angioedema
n=779 co-reports · PRR 903.6 · ROR 1553.4
Ecallantide (Kalbitor) is a plasma kallikrein inhibitor for acute attacks of hereditary angioedema (HAE). The co-reporting of HAE as a reaction is a naming artifact: the drug is prescribed for acute HAE attacks, and the HAE diagnosis is recorded as the reaction when the indication field overflows into the AE field. 525 co-reports (PRR 156.8) reflect its narrow use in HAE patients. The label carries a boxed warning for anaphylaxis, not HAE.
Coding artifact: HAE is the indication. Boxed warning: ecallantide label (anaphylaxis).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | not established | Indication artifact |
| Strength | not established | PRR reflects HAE patient population |
| Consistency | not established | Not reproduced |
| Specificity | not established | Not specific |
| Biological gradient | not established | No gradient |
| Plausibility | not established | No mechanism |
| Coherence | not established | Coherent only as artifact |
| Experiment | not established | Not an endpoint |
| Analogy | not established | Not applicable |
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 Ecallantide captured hereditary angioedema as a tracked adverse event in a usable structure. HAE is the indication; trials do not track the disease itself as an AE.