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A new prospective study confirms previous suggestions that in very low-birth-weight newborns exposed to treatment with ranitidine for gastric acid suppression, the rate of infections is significantly higher, as are the risk of necrotizing enterocolitis, length of hospital stay, and fatal outcome.
A new prospective study confirms previous suggestions that in very low-birth-weight (VLBW) newborns exposed to treatment with ranitidine for gastric acid suppression, the rate of infections is significantly higher, as are the risk of necrotizing enterocolitis (NEC), length of hospital stay, and fatal outcome.
The findings released by researchers from Italy note that histamine-2 receptor blockers and proton pump inhibitors are increasingly used off-label in neonatal intensive care units for prevention or therapy of stress ulcers and gastroesophageal reflux disease (GERD). Although previous reports have suggested increased morbidity and mortality associated with ranitidine use in VLBW newborns-gastric juice being a major nonimmune defense mechanism against infections-the investigators say their study overcomes limitations in all the previous findings.
Data obtained from 274 infants at 4 medical centers, with 91 receiving ranitidine (42 as prophylaxis of stress-induced peptic disease; 49 because of suspected GERD) and 183 in the control cohort of newborns not exposed to ranitidine, showed that
The infection rate was significantly higher in the ranitidine cohort than in controls (37.4% vs 9.8%, respectively), led by sepsis (25.3% vs 8.7%), pneumonia (4.4% vs 0.5%), and urinary tract infections (7.7% vs 0.5%).
The risk of NEC was 6.6-fold higher in ranitidine-treated infants than in control infants.
The mortality rate was about 6 times higher in newborns receiving ranitidine than controls (9.9% vs 1.6%).
Hospital stays were longer in the ranitidine cohort-a median of 52 days compared with 36 days for the infants not exposed to ranitidine.
Duration of ranitidine treatment did not affect the risk for infection.
On the basis of the existing evidence, the researchers suggest that the direct effect exerted by ranitidine on the immune system could influence the risk for NEC, or that hypochlorhydria induced by ranitidine may significantly alter the intestinal microflora, which in turn could contribute to the increased susceptibility to infections, or that development of NEC could be a result of the selective advantage acquired by pathogens during inhibition of gastric acidity.
They conclude that ranitidine should be administered only after a careful consideration of the risk-benefit ratio and that based on the observed increase in mortality in newborns receiving ranitidine, caution should be exercised regarding its administration in VLBW infants at high risk of death.