title: Exposure to nitrofurantoin during the first trimester of pregnancy and the risk for major malformations.
abstract: Antibacterial drugs are among the most common medications used by pregnant women. While medical literature generally defines nitrofurantoin as an antibiotic that is safe for use during the first trimester of pregnancy, new concerns about a possible association between congenital malformations following exposure to nitrofurantoin during the first trimester of pregnancy have recently surfaced. To address these concerns, we conducted a large population-based retrospective cohort study to assess this possible association (including cases of medical terminations of pregnancy or stillbirth) and congenital malformations. A computerized database for medications dispensed to pregnant women in southern Israel was linked with records from the district hospital. Associations between exposure to nitrofurantoin during the first trimester and major malformations were assessed. Our research included a total of 105,492 pregnancies, 1,112 of which involved pregnancy terminations for medical reasons. A total of 1,329 infants and abortuses had been exposed to nitrofurantoin during the first trimester of pregnancy. Exposure to nitrofurantoin was not associated with increased risk of major malformations in general (adjusted OR = 0.85, 95% CI 0.67-1.08) or with specific malformations. First trimester exposure to nitrofurantoin was not associated with increased risk for total major congenital malformations or with specific malformations.
authors.affiliation: Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: Ori
authors.initials: O
authors.lastname: Goldberg
authors.forename: Gideon
authors.initials: G
authors.lastname: Koren
authors.forename: Daniella
authors.initials: D
authors.lastname: Landau
authors.forename: Eitan
authors.initials: E
authors.lastname: Lunenfeld
authors.forename: Ilan
authors.initials: I
authors.lastname: Matok
authors.forename: Amalia
authors.initials: A
authors.lastname: Levy
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000328:Adult; D000892:Anti-Infective Agents, Urinary / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008431:Maternal-Fetal Exchange; D009582:Nitrofurantoin / Q000627:therapeutic use*; D016017:Odds Ratio; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D012306:Risk; D014552:Urinary Tract Infections / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000892:Anti-Infective Agents, Urinary; D009582:Nitrofurantoin
keywords: congenital malformations; nitrofurantoin; pregnancy