title: Antibiotics potentially used in response to bioterrorism and the risk of major congenital malformations.
abstract: This study was designed to assess the association between pregnancy-related exposures to antibiotics recommended for use in the event of a bioterrorism attack and major congenital malformations. A retrospective cohort study included 30 049 infants from Tennessee Medicaid born between 1985 and 2000 identified from computerised state databases. Infants with fetal exposures to ciprofloxacin, azithromycin, doxycycline and amoxicillin (antibiotics recommended for potential bioterrorism attacks) (n = 24 521) and erythromycin (included as a positive control) (n = 2128) were compared with infants with no fetal exposure to any antibiotics (n = 3400). Major congenital malformations identified from computerised records were confirmed through medical record review. Overall, 869 (2.9%) of infants in the cohort had a confirmed major congenital malformation, with major malformations ranging from 2.5% to 3.0% among the antibiotic-specific exposure groups. No increased risk was present in multivariable analyses for any malformations and for malformations of specific organ systems. In conclusion, these data suggest that ciprofloxacin, azithromycin, doxycycline or amoxicillin use by pregnant women should not result in a greater incidence of overall major congenital malformations in infants whose mothers take these medications, though a large increase in risk cannot be ruled out.
authors.affiliation: Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN 37232-2504, USA. william.cooper@vanderbilt.edu
authors.forename: William O
authors.initials: WO
authors.lastname: Cooper
authors.forename: Sonia
authors.initials: S
authors.lastname: Hernandez-Diaz
authors.forename: Patrick G
authors.initials: PG
authors.lastname: Arbogast
authors.forename: Judith A
authors.initials: JA
authors.lastname: Dudley
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Dyer
authors.forename: Patricia S
authors.initials: PS
authors.lastname: Gideon
authors.forename: Kathleen S
authors.initials: KS
authors.lastname: Hall
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Kaltenbach
authors.forename: Wayne A
authors.initials: WA
authors.lastname: Ray
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D000658:Amoxicillin / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D017963:Azithromycin / Q000009:adverse effects; D023482:Bioterrorism; D002939:Ciprofloxacin / Q000009:adverse effects; D004318:Doxycycline / Q000009:adverse effects; D004917:Erythromycin / Q000009:adverse effects; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced*; D011322:Primary Prevention; D012042:Registries / Q000706:statistics & numerical data; D012189:Retrospective Studies; D018570:Risk Assessment; D013714:Tennessee / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D002939:Ciprofloxacin; D004917:Erythromycin; D000658:Amoxicillin; D017963:Azithromycin; D004318:Doxycycline