SPIRONOLACTONE

By Gary M. White, MD

Note, this is a brief summary only and is meant to emphasize dermatologic aspects. More complete information, including the package insert and recent studies should be consulted before prescribing.


Spironolactone is heart-medication that is also effective in the treatment of acne in adult women. However, it not FDA-approved for the treatment of acne.

Indications

FDA-approval in 1960. Current FDA-approved indications:

Spironolactone is not FDA-approved for acne.

Notes for Use in Acne



Physiologic Effects

Hyperkalemia

Researchers reviewed the records of 974 healthy women aged 18-45 who were prescribed spironolactone for acne [JAMA Dermatol. 2015;151;941]. Of 1802 serum potassium measurements over 14 years, 13 (0.72%) showed mild hyperkalemia (5.1-6.0 mEq/l) which was similar to the baseline rate (0.76%) in this population. Six were retested and all had normal values on subsequent test.

When to Measure the K+?

It seems reasonable to check the K+ in the following situations:

Hyperkalemia--Warning Signs

Drug Interactions

Side Effects

Blood Pressure

Women with baseline low blood pressure may have trouble with lightheadedness and even syncope. The blood pressure in these patients should be monitored at followup visits.

Pregnancy Category D

Black Box Warning

Spironolactone has been shown to be a tumorigenic in chronic toxicity studies in rats. Spironolactone should be used only in those conditions described under Indications and Usage. Unnecessary use of this drug should be avoided.

Note: Dosages used in these rat studies were 25-100 times higher than those administered to humans.

Cancer?

With respect to breast, uterus, ovarian, and cervical cancer, there does not seem to be evidence of increased risk with spironolactone [Cancer Epidemiol 2013;37:870-5].

How Long?

One study of 200 person-years of exposure to spironolactone and 506 person-years of followup over 8 years found no serious illnesses thought to be attributed to spironolactone [J Cutan Med Surg 2002;6:541-5].

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