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January 18, 1980

Reactions to Povidone Iodine Preparation

Author Affiliations

Food and Drug Administration Rockville, Md

JAMA. 1980;243(3):230-231. doi:10.1001/jama.1980.03300290014008

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To the Editor.—  In a recent letter, Feldtman and co-workers (242:239, 1979) reported that altered immune status of patients may be responsible for the cutaneous erythema, induration, and papulation observed in patients treated with 10% povidine iodine (Betadine).They conclude that such cutaneous sensitivity may be an indication that the patient has altered immunocompetence or even an occult malignant neoplasm. Their conclusions have merit and should be noted by the medical community. We would like to relate similar incidences with povidone-iodine that were reported approximately 12 to 18 months ago, investigations of which led us to a different conclusion. The Food and Drug Administration received an unusually high number of complaints concerning adverse reactions, citing skin erythema, tissue necrosis, and similar other skin-related problems, with the use of 10% povidone-iodine solution. During the investigation of these reports, we found that the manufacturer had recently changed the formulation to improve product's