title: Ranitidine is associated with infections, necrotizing enterocolitis, and fatal outcome in newborns.
abstract: OBJECTIVE
  Gastric acidity is a major nonimmune defense mechanism against infections. The objective of this study was to investigate whether ranitidine treatment in very low birth weight (VLBW) infants is associated with an increased risk of infections, necrotizing enterocolitis (NEC), and fatal outcome.
  
  
  METHODS
  Newborns with birth weight between 401 and 1500 g or gestational age between 24 and 32 weeks, consecutively observed in neonatal intensive care units, were enrolled in a multicenter prospective observational study. The rates of infectious diseases, NEC, and death in enrolled subjects exposed or not to ranitidine were recorded.
  
  
  RESULTS
  We evaluated 274 VLBW infants: 91 had taken ranitidine and 183 had not. The main clinical and demographic characteristics did not differ between the 2 groups. Thirty-four (37.4%) of the 91 children exposed to ranitidine and 18 (9.8%) of the 183 not exposed to ranitidine had contracted infections (odds ratio 5.5, 95% confidence interval 2.9-10.4, P < .001). The risk of NEC was 6.6-fold higher in ranitidine-treated VLBW infants (95% confidence interval 1.7-25.0, P = .003) than in control subjects. Mortality rate was significantly higher in newborns receiving ranitidine (9.9% vs 1.6%, P = .003).
  
  
  CONCLUSIONS
  Ranitidine therapy is associated with an increased risk of infections, NEC, and fatal outcome in VLBW infants. Caution is advocated in the use of this drug in neonatal age.
authors.affiliation: Department of Women’s Health and Territorial Medicine, University La Sapienza, Rome, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Terrin
authors.forename: Annalisa
authors.initials: A
authors.lastname: Passariello
authors.forename: Mario
authors.initials: M
authors.lastname: De Curtis
authors.forename: Francesco
authors.initials: F
authors.lastname: Manguso
authors.forename: Gennaro
authors.initials: G
authors.lastname: Salvia
authors.forename: Laura
authors.initials: L
authors.lastname: Lega
authors.forename: Francesco
authors.initials: F
authors.lastname: Messina
authors.forename: Roberto
authors.initials: R
authors.lastname: Paludetto
authors.forename: Roberto Berni
authors.initials: RB
authors.lastname: Canani
mesh_terms: D000897:Anti-Ulcer Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001424:Bacterial Infections / Q000209:etiology* / Q000276:immunology; D020345:Enterocolitis, Necrotizing / Q000139:chemically induced*; D005260:Female; D005744:Gastric Acid / Q000378:metabolism; D006635:Histamine H2 Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000139:chemically induced* / Q000276:immunology / Q000401:mortality / Q000517:prevention & control; D019102:Infant, Very Low Birth Weight; D008297:Male; D010437:Peptic Ulcer / Q000517:prevention & control; D011899:Ranitidine / Q000009:adverse effects* / Q000627:therapeutic use; D012307:Risk Factors
chemical_list: D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D011899:Ranitidine