NEWPORT BEACH, CALIF. (FRONTLINE MEDICAL NEWS) – While off-label use of spironolactone for treatment of acne is quite common, it should be prescribed with special caution, advised Julie C. Harper, MD.

“The vast majority of you write this for acne,” Dr. Harper, a dermatologist in private practice in Birmingham, Ala., said during a presentation on adult acne at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

She offered this blunt advice about one potential patient group: “Do not use this in men.” She cited a 2006 Japanese study of 139 patients with acne, treated with oral spironolactone, which found that 3 of the 23 males in the study developed gynecomastia within 4-6 weeks. Subsequently, the treatment was stopped in all male patients ( Aesthetic Plast Surg. 2006 Nov-Dec;30[6]:689-94 ).

In the same study, 80% of the 116 females in the study experienced menstrual irregularities. “We have to tell our patients that’s a possible side effect, that they may get breast tenderness or menstrual irregularities,” Dr. Harper said. “If you don’t tell them, they’re not thinking of acne drugs as causing this.”

What about the risk of hyperkalemia in patients who take spironolactone, which is a diuretic? A retrospective study found similar hyperkalemia rates among healthy young women taking spironolactone for acne or an endocrine disorder with associated acne (mean age 26-27 years) and among healthy young women not taking spironolactone. The authors concluded that routine potassium testing was not necessary in healthy young women who take the drug ( JAMA Dermatol. 2015 Sep;151[9]:941-4 ).

Dr. Harper recommended testing, however, if patients are older, have a history of renal or cardiac disease, have impaired hepatic function, or are taking higher doses of spironolactone.

She also cautioned that spironolactone should not be taken with lithium, and that it boosts the risk of digoxin toxicity.

Research doesn’t indicate that the risk of breast cancer is increased in women taking spironolactone, she said, nor does there appear to be a risk in lactating mothers. But the drug should not be taken during pregnancy or by women who could become pregnant, she noted.

Dr. Harper warned against the use of tetracyclines and erythromycin estolate when treating pregnant women with acne. She avoids using topical retinoids, although she said they are probably safe in small areas. Benzoyl peroxide is acceptable for small areas, as are topical azelaic acid and clindamycin, she added.

For information about acne treatment in lactating mothers, she cited a 2014 review ( J Am Acad Dermatol. 2014 Mar;70[3]:417.e1-417.e10. ).Erythromycin, azithromycin, and clarithromycin are considered appropriate for short-term use, she said, as are tetracyclines, but for less than 3 weeks only. Oral clindamycin is acceptable, but may cause gastrointestinal side effects in the nursing infant; topical use appears to be appropriate, she said.

Topical treatment with benzoyl peroxide is also appropriate for lactating women, she said, and topical retinoids are probably safe on small areas. Topical azelaic acid is considered a low risk to the nursing infant, she added.

Dr. Harper disclosed financial relationships of various types with Allergan, Bayer, BiopharmX, Galderma, Novan, Promius and Valeant.

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