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John M. Restaino DPM, JD, MPH
John M. Restaino DPM, JD, MPH
Attorney •

Study Links Hearburn Medication With Dangerous or Fatal Outcomes for Low Birth Weight Infants

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Babies with acid reflux (gastroesophageal reflux disease or GERD) are often given Zantac syrup containing ranitidine to block acid production in the stomach. To date, there have not been any side effects of Zantac syrup reported, other than causing sleepiness.

However, a new study of premature infants (between 24 and 32 weeks) and full term infants weighing less than 3.5 pounds links ranitidine heartburn medication (Zantac) with a very high risk of infections, death of intestinal tissue and fatal outcomes.

A group of researchers from the Department of Women’s Health and Territorial Medicine, University La Sapienza, Rome, Italy evaluated 274 very low birth weight infants, 91 of who were given ranitidine versus 183 who were not.

The study found 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 representative of a 450% increased risk.

The risk of death of the intestines was 6.6-fold higher in ranitidine-treated infants than in control subjects.

The over-all death rate was over 6-times higher in newborns receiving ranitidine (9.9% vs 1.6%).

These researchers concluded that ranitidine therapy is associated with an increased risk of infections, intestinal death, and fatal outcome in very low birth weight infants. We will continue to follow the small study to see if it warrants FDA action.