Anti-Reflux Drugs May Be Overprescribed in Infants

MONDAY Nov. 5, 2007 -- Doctors may be overprescribing anti-reflux medications to infants, new research suggests.

The study found that fewer than one in five babies given anti-reflux medications, which work by lowering levels of stomach acid, actually had elevated acid levels. That means four out of five infants included in the study likely didn't need anti-reflux medications, and may have simply been experiencing normal infant regurgitation commonly referred to as "spitting up."

"In the absence of red flags, such as a child who is not gaining weight, has feeding problems or a learned aversion to food, a chronic cough or recurrent respiratory problems or apnea, regurgitation may not require medication," said study author Dr. Vikram Khoshoo, a pediatric gastroenterologist at the Pediatric Specialty Center at West Jefferson Medical Center in New Orleans.

"Regurgitation won't improve with anti-reflux medications. Acid suppression will improve irritability and feeding problems, but it won't change spitting up. As long as the child is gaining weight and happy, and has no recurrent red flags, regurgitation is a laundry problem, not a medical problem," Khoshoo said.

The findings are published in the November issue of Pediatrics.

Reflux is common in infants. In fact, more than half experience reflux symptoms during the first three months of life, according to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases. Symptoms of reflux include spitting up, vomiting, coughing, feeding difficulty and irritability.

Khoshoo and his colleagues reported that back in 1998 and 1999, infants with regurgitation made up about 14 percent of their referrals, and about 40 percent of those babies were already on anti-reflux medication or on special easier-to-digest formula. But by 2006 to 2007, infants with regurgitation accounted for 23 percent of their referrals, and 90 percent were already on medications or special formula.

"We felt it was unlikely that the incidence had increased so suddenly," Khoshoo said.

To measure whether or not these infants' symptoms were caused by acid reflux, the researchers conducted pH studies on 44 babies with persistent regurgitation. The average age of the babies was 18 weeks.

To complete a pH study, doctors must thread a wire down the nose and leave it in place for 24 hours, Khoshoo said, so it's not a test that would be practical to do on every child with regurgitation.

Of the 44 babies tested, only eight showed elevated pH levels, meaning they had excess levels of stomach acid, and anti-reflux medications would be indicated in these cases. However, 42 of the babies were already on such medications, meaning that many were taking a medication they didn't need.

While these medications are generally considered safe, Khoshoo said there is some concern that they may affect calcium metabolism, and they've been associated with osteoporosis in older people who take them for long periods of time.Because infants are building new bones, this potential side effect is even more concerning, Khoshoo added.

Dr. David Keljo is a pediatric gastroenterologist and director of the Inflammatory Bowel Disease Center at Children's Hospital of Pittsburgh. He said, "Reflux in babies is a tough issue, and I think the concerns in this study are well-raised. Babies may be cranky from reflux or from something else. The vast majority will outgrow their reflux whether we do anything or not."

Both Khoshoo and Keljo said these medications are probably overprescribed because parents want to do something, anything to try to stop their babies' regurgitation and irritability.

Khoshoo said that taking care not to overfeed your infant and making sure he or she is positioned so that their bodies are at least somewhat upright after eating will help to lessen reflux symptoms. Another critical thing parents can do, he said, is make sure that children aren't exposed to secondhand smoke, which can increase reflux symptoms.

Keljo said there are certain signs that indicate your baby should be evaluated by a specialist. If your child throws up blood, a substance that looks like coffee grounds, or if there's green in the vomit, your child should be seen right away. Also, if your child isn't gaining weight or is even losing weight, if you can hear significant choking sounds, if there's a chronic cough or hoarseness that accompanies regurgitation, your child should see a gastroenterologist, he said.

More information

To learn more about acid reflux in babies, visit the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.

Posted: November 2007


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