Are acid-suppressing drugs prescribed too often in infants?

In a soon to be published Commentary in The Journal of Pediatrics, Eric Hassall, MBChB, FRCPC, FACG, cautions against the over-diagnosis of GERD and over-prescription of acid-suppressing drugs in infants.

Dr. Hassall is affiliated with the Department of Pediatrics at the University of British Columbia, Vancouver, Canada, is currently Staff Gastroenterologist at Sutter Pacific Medical Foundation in San Francisco, California, and is an advisor to the U.S. Food and Drug Administration (FDA). Although the FDA has only approved the use of acid-suppressing drugs, such as proton pump inhibitors (PPIs), in children over the age of one year, the use of PPIs in infants less than 12 months old has greatly increased in the last decade.

Dr. Hassall notes that most "reflux" in infants is not acidic because stomach contents have been buffered by frequent feedings. "However, in the absence of better information and physician guidance and fed by advertising and misinformation on the Internet, distressed parents take their concerns to doctors, who very frequently comply and prescribe acid-suppressing medications for symptoms and signs that, in most cases, are not GERD," he states.

Studies have shown that PPIs are no better than placebo for most infants with symptoms of spitting up, irritability, or unexplained crying, which may be because the medications are frequently prescribed for symptoms that are not GERD. Dr. Hassall emphasizes that spitting up in otherwise healthy infants is normal and resolves with time. Irritability or unexplained crying, with or without spitting up, is often a normal developmental phenomenon, especially in infants 2-5 months old. Although some infants are unable to self-calm, this also improves with maturation and age.

"We are medicalizing normality," Dr. Hassall asserts, "In most infants, these symptoms are 'life,' not a disease, and do not warrant treatment with drugs, which can have significant adverse effects." He explains that gastric acid is an early line of defense against infection and is important for nutrition; by prescribing acid-suppressing medications to infants without GERD, pediatricians are putting their patients at a higher risk for infections like pneumonia and gastroenteritis. The use of PPIs in infants can also lead to abnormalities in the levels of essential minerals and vitamins, such as magnesium, calcium, and vitamin B12.

Dr. Hassall encourages his fellow pediatricians to initially explore nonpharmacological approaches, such as changes in maternal diet of breastfeeding mothers or hypoallergenic formulas for bottle-fed infants. However, if these approaches fail or if an infant has severe symptoms and is suspected of having actual GERD, Dr. Hassall suggests beginning treatment with an acid-suppressing medication for a time-limited period of 2 weeks. However, as Dr. Hassall notes, "In most cases, it is not the spitting up that should be treated. The real issue is the unexplained crying, which causes real and considerable distress and concern for parents." He goes on to say, "It is important for pediatricians to acknowledge their concerns, explain the spectrum of normal infant behavior, discuss the range of measures available, start implementation, and be available for follow-up."