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Nystatin Pregnancy and Breastfeeding Warnings

Nystatin is also known as: Bio-Statin, Mycostatin, Mycostatin Pastilles, Nilstat, Nystat-Rx, Nystex

Nystatin Pregnancy Warnings

In a review of 229,101 deliveries to Michigan Medicaid patients, 489 first-trimester exposures to nystatin and 1881 exposures any time during pregnancy were recorded. Both systemic and nonsystemic exposures were included. A total of 20 birth defects were reported with first trimester exposure (21 expected) and included (observed/expected) 3/5 cardiovascular defects, 1 cleft palate, 1 polydactyly, and 1 limb reduction. (Written communication, Franz Rosa, MD, Food and Drug Administration, 1994). These data do not support an association with birth defects. Nystatin has been used for the treatment of vaginal candidiasis in several studies, generally during the second and third trimester, without association with adverse fetal outcome. In one study, nystatin was administered to 244 women in all stages of pregnancy. One infant was born with congenital heart disease, one infant was born with hip "clicks" on abduction, and one infant was born premature with hyaline membrane disease.

Nystatin has been assigned to pregnancy category A by the FDA when administered as a vaginal suppository and to category C when administered as an oral troche. Nystatin has not been associated with adverse fetal outcome, however nystatin is only recommended for use during pregnancy when benefit outweighs risk.

Nystatin Breastfeeding Warnings

There are no data on the excretion of nystatin into human milk. However, nystatin is not thought to be absorbed after application to skin or mucous membranes.

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