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Foetal Safety of Nitrofurantoin Macrocrystals Therapy during Pregnancy: A Retrospective Analysis

Urinary tract infection during pregnancy poses increased risk to mother and foetus and warrants prompt detection and treatment. Currently, there are no antibacterials approved for use in pregnant women. A retrospective analysis was undertaken to evaluate the safety to the human foetus of nitrofurantoin macrocrystals (Macrodantin®) when administered during pregnancy. The records of ninety-one pregnancies in eighty-one obstetric patients who were treated with nitrofurantoin macrocrystals for urinary tract infection were reviewed. Safety was assessed according to incidence of foetal death, neonatal death, malformation, prematurity, low birth weight, low Apgar score and jaundice. The incidence of abnormal events in the pregnancies evaluated was not significantly different from that in the United States population. No abnormal event was considered to be drug-related. This study yielded no evidence that would implicate nitrofurantoin macrocrystals as toxic to the foetus or unsafe for treatment of maternal urinary tract infection during pregnancy.