Doxorubicin (anthracyclines) and Cardiotoxicity / cardiomyopathy: is the FAERS signal real?
Doxorubicin (anthracyclines) ↔ Cardiotoxicity / cardiomyopathy
Doxorubicin, a key anthracycline chemotherapy drug, damages heart muscle in a cumulative, dose-dependent way that can lead to a potentially irreversible cardiomyopathy and heart failure. The risk rises sharply above a total lifetime dose threshold and is worsened by chest radiotherapy, age, and other heart-toxic drugs, which is why heart function is monitored during treatment and why dexrazoxane is sometimes used as a protectant. The 1,221 co-reports (PRR 37.7) reflect both the real effect and the drug's wide use in breast cancer, lymphoma, and leukaemia.
Regulatory basis: doxorubicin prescribing information (cardiotoxicity warning; cumulative-dose limits; cardiac monitoring).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Heart-muscle damage accumulates with dose and may manifest during or after therapy |
| Strength | met | PRR 38 on a large co-report count |
| Consistency | met | Reproduced across oncology practice |
| Specificity | met | A signature anthracycline effect |
| Biological gradient | met | Clearly cumulative-dose-related |
| Plausibility | met | Free-radical oxidative damage to heart muscle is the mechanism |
| Coherence | met | Coheres with the labelled cumulative-dose limits and monitoring |
| Experiment | partial | Dechallenge (stopping the drug) limits further damage; no randomized trial |
| Analogy | met | Analogous to cardiotoxicity from other anthracyclines and trastuzumab |
This page's own qualitative read, not an automated/citation-gated assessment.