Usefulness of Proton Pump Inhibitors in Children Called into Question

A new study is questioning whether giving children heart burn drugs called <"">proton pump inhibitors is beneficial, or even safe. Such drugs, including Prilosec, Prevacid, and Nexium, are being prescribed more often to treat gastroesophageal reflux disease, or GERD, in infants, children and teenagers.

According to the study, published in the journal Pediatrics, the researchers were only able to find 12 clinical trials that fit their criteria of being a trial where infants, children, or teens were randomly assigned to take a proton pump inhibitor or a comparison treatment. The studies reviewed involved 895 children up to age 17. All were sufficiently different in design and outcomes that a formal meta-analysis was not possible, though the researchers did perform a systemic analysis.

A total of five studies involved infants. Of those, one showed evidence that a proton pump inhibitor was more effective than hydrolyzed formula in easing GERD symptoms. In two, proton pump inhibitors were not as effective as placebo in reducing reflux symptoms, while they were seen to be equally effective in two others. Only three of the five studies reported any adverse events, but none reported a significant difference in treatment-related events. One study, however, found that babies treated with proton-pump inhibitors had a higher rate of lung infections.

Another five studies reviewed by the researchers looked at children age 6 months to 13.4 years. In all five, the drugs were as effective as their comparators, with a significant reduction in GERD symptoms from baseline in all treatment groups. Two studies reported mild-to-moderate adverse events related to treatment, with the most common being headache and diarrhea.

The final two studies reviewed by the researchers looked at teens, age 12 to 17. Both found proton pump inhibitors were as effective as their comparators in reducing GERD symptoms. In one, headache (35%), infection (23%), and pharyngitis (19%) were the most commonly reported treatment-related adverse events; while in the second study, headache (8%), abdominal pain (3%), and diarrhea (2%) were the most frequently reported. Neither reported a significant difference in adverse events between study groups.

The researchers concluded that evidence is lacking to show that proton pump inhibitors are a safe and effective way to treat GERD in children, especially infants. Clinicians should be careful when they use the drugs in children and adolescents, they concluded. The authors of the study called for further, well-designed trials to see how effective and safe proton-pump inhibitors are for children.

According to a Reuters report, there are other ways to cope with acid reflux in children. For babies, thickeners can be added to formula, and changes to feeding positions can help. Older children can ease symptoms by eating smaller meals or avoiding foods that trigger reflux. Other acid-suppressing medications called H2 blockers, which include Zantac, Pepcid and Tagamet, are also an option.

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