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Ranitidine is associated with infections, necrotizing enterocolitis, and fatal outcome in newborns.

Abstract

BACKGROUND AND OBJECTIVES
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.

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  • Publisher Full Text

    • Authors

    Terrin G, Passariello A, De Curtis M, Manguso F, Salvia G, Lega L, Messina F, Paludetto R, Canani RB

    Institution

    Department of Women’s Health and Territorial Medicine, University La Sapienza, Rome, Italy.

    Source

    Pediatrics 129:1 2012 Jan pg e40-5

    MeSH

    Anti-Ulcer Agents
    Bacterial Infections
    Enterocolitis, Necrotizing
    Female
    Gastric Acid
    Histamine H2 Antagonists
    Humans
    Infant, Newborn
    Infant, Premature
    Infant, Premature, Diseases
    Infant, Very Low Birth Weight
    Male
    Peptic Ulcer
    Ranitidine
    Risk Factors

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    22157140