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The association between drospirenone and hyperkalemia: a comparative-safety study.
Steven T Bird1,2, Salvatore R Pepe1,2, Mahyar Etminan3
1Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research (CDER)/Office of Management/CDER Academic Collaboration Program, Bldg 22, 10903 New Hampshire Avenue, Silver Spring, MD USA 20993.
BMC Clinical Pharmacology
|January 3, 2012
Summary
Drospirenone oral contraceptives did not show a significant hyperkalemia risk in this study. Physicians often prescribe drospirenone with spironolactone, but fail to monitor potassium levels as recommended.
Area of Science:
- Pharmacovigilance
- Reproductive Health
- Clinical Pharmacology
Background:
- Drospirenone/ethinyl-estradiol is an oral contraceptive (OC) with antimineralocorticoid properties.
- Concerns exist regarding drospirenone's potential to increase hyperkalemia risk, alone or with spironolactone.
Purpose of the Study:
- To evaluate the association between drospirenone-containing OCs and hyperkalemia risk.
- To assess the concomitant use of drospirenone and spironolactone and adherence to monitoring guidelines.
Main Methods:
- Retrospective cohort study of 1,148,183 women (18-46 years) using new-user OCs (1997-2009).
- Cox proportional hazards models compared hyperkalemia risk with drospirenone vs. levonorgestrel OCs.
- Logistic regression analyzed concurrent drospirenone and spironolactone prescribing.
Main Results:
- No clinically significant hyperkalemia signal was found for drospirenone compared to levonorgestrel (HR 1.10; 95% CI 0.95-1.26).
- Norethindrone (HR 1.15) and norgestimate (HR 1.27) OCs showed increased hyperkalemia risk.
- Concomitant prescribing of drospirenone and spironolactone was significantly higher (OR 2.66) than with levonorgestrel.
- Only 6.5% of patients on combined therapy had potassium monitoring.
Conclusions:
- This study did not demonstrate a clinically significant hyperkalemia risk associated with drospirenone OCs.
- Physicians frequently co-prescribe drospirenone with spironolactone, often disregarding package insert monitoring recommendations.
- Adherence to potassium monitoring guidelines for combined drospirenone and spironolactone therapy is suboptimal.
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