Methyldopa and Drug-induced liver injury: is the FAERS signal real?
Methyldopa ↔ Drug-induced liver injury
Methyldopa, a centrally acting antihypertensive still used in pregnancy, is a classic cause of drug-induced liver injury — from asymptomatic transaminase rises to rare fatal fulminant hepatitis, with 75 co-reports here (PRR 10.6). The injury is idiosyncratic and typically appears within the first weeks to months of therapy, which is why periodic liver monitoring is advised early in treatment; it remains a reason methyldopa has largely been displaced by safer agents outside pregnancy.
Regulatory basis: methyldopa prescribing information — hepatotoxicity warning; classic drug-induced liver-injury literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Onset typically weeks into therapy |
| Strength | met | PRR 10.6, clearly elevated |
| Consistency | met | Long recognised in case series |
| Specificity | not established | Cannot be distinguished from other DILI clinically |
| Biological gradient | not established | Not clearly dose-related (idiosyncratic) |
| Plausibility | met | Idiosyncratic drug-reaction mechanism |
| Coherence | met | Fits the DILI pattern |
| Experiment | n/a | No trial-sized experiment possible |
| Analogy | met | Analogous to other idiosyncratic hepatotoxins |
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.