Spironolactone Use among Young Women for acne treatment Growing despite Safety Concerns: JAMA
Researchers have found in a new study that use of spironolactone among young women and girls has increased since 2000, primarily for acne and androgen-related conditions. While the drug is well-established for cardiovascular issues, its safety for relatively healthy individuals using it off-label remains unproven. The FDA warns of potential risks, including hyperkalemia, hypotension, worsening renal function, electrolyte imbalances, metabolic abnormalities, and gynecomastia.
Spironolactone is FDA-approved for cardiovascular disease but is widely prescribed off-label for androgen-related conditions such as acne in young women and girls, often at higher doses (100-200 mg/d) than cardiovascular uses (25 mg/d). While clinical trials have primarily focused on older adults with heart failure, safety concerns related to androgen deprivation, including vulvar pain, have emerged in case reports. However, large-scale safety evaluations in younger populations remain limited. Given spironolactone’s increasing use for acne, particularly among adolescents, understanding prescribing trends can inform the need for further safety studies.This cohort study analyzed prescribing trends from 2000 to 2020 among 38 million insured females aged 12 to 40 years using deidentified claims data. Among 451,234 new spironolactone users (1.2% of the cohort), 11.5% were aged 12 to 18 years at initiation. Acne was the most common diagnosis (55.5%), followed by hirsutism (8.3%) and polycystic ovary syndrome (8.1%). Cardiovascular conditions were rare, with hypertension (4.0%) and congestive heart failure (0.8%). Notably, 29.4% of users lacked a recorded diagnosis for these conditions, possibly indicating alternative uses such as cancer-related edema management. New prescriptions increased from 17 per 100,000 covered individuals in 2000 to 88 per 100,000 in 2020, with the highest growth among those aged 19 to 25 years. Despite potential misclassification of indications due to insurance reimbursement factors, the study found a significant rise in spironolactone use among young women and girls, with most users requiring doses higher than those evaluated in cardiovascular trials. Given its widespread use and the potential for safety concerns, particularly regarding androgen deprivation effects, further targeted safety studies may be necessary to assess risks in this population.
Reference:
Soppe SE, Robinson WR, Lachiewicz MP, Wood ME. Trends in the Proportion of Young Women and Girls Prescribed Spironolactone. JAMA Netw Open. 2025;8(3):e250842. doi:10.1001/jamanetworkopen.2025.0842
Keywords:
Spironolactone, Use, among, Young, Women, acne, treatment, Growing, despite, Safety, Concern, JAMA, Soppe SE, Robinson WR, Lachiewicz MP, Wood ME
