From the FDA Drug Label
- 1 Carcinogenesis, Mutagenesis, Impairment of Fertility Eplerenone was non-genotoxic in a battery of assays including in vitrobacterial mutagenesis (Ames test in Salmonellaspp. and E Coli), in vitromammalian cell mutagenesis (mouse lymphoma cells), in vitrochromosomal aberration (Chinese hamster ovary cells), in vivorat bone marrow micronucleus formation, and in vivo/ex vivounscheduled DNA synthesis in rat liver There was no drug-related tumor response in heterozygous P53 deficient mice when tested for 6 months at dosages up to 1000 mg/kg/day (systemic AUC exposures up to 9 times the exposure in humans receiving the 100 mg/day therapeutic dose) Statistically significant increases in benign thyroid tumors were observed after 2 years in both male and female rats when administered eplerenone 250 mg/kg/day (highest dose tested) and in male rats only at 75 mg/kg/day.
The FDA drug label does not contain a black box warning for tumors related to eplerenone 1.
From the Research
Eplerenone does not have a black box warning for tumors. This medication, which is a selective aldosterone receptor antagonist used primarily for treating hypertension and heart failure, has a different safety profile than some other medications in related classes. While eplerenone does carry warnings for potential side effects such as hyperkalemia (elevated potassium levels), particularly in patients with renal impairment or diabetes, it has not been associated with tumor development that would warrant a black box warning from regulatory agencies 2. The medication works by blocking aldosterone receptors in the kidneys, heart, and blood vessels, which helps reduce blood pressure and decrease cardiac workload.
Some key points to consider when prescribing eplerenone include:
- Monitoring for electrolyte imbalances, particularly potassium levels, as hyperkalemia is a potential side effect 3, 4, 5, 6
- Careful patient selection, as certain populations (such as those with renal impairment or diabetes) may be at higher risk for hyperkalemia or worsening renal function 6
- The benefits of eplerenone in reducing morbidity and mortality in patients with heart failure and hypertension, as demonstrated in studies such as the EMPHASIS-HF trial 3, 6
Overall, eplerenone is a safe and effective medication for the treatment of hypertension and heart failure, without a black box warning for tumors. Patients taking eplerenone should be monitored for electrolyte imbalances, particularly potassium levels, but do not need specific monitoring related to tumor risk as this is not a recognized concern with this medication 2.