Are Infant Reflux Drugs Worth the Risks?

The number of babies prescribed acid suppression drugs such as H2 blockers and PPIs grew 8-fold during 2002 to 2009, but fewer than 10% received any diagnostic testing for GERD (Gastroesophageal Reflux Disease). Some pediatricians are growing concerned that the “epidemic” of infant GERD cases is actually due to over-diagnosis, especially since clinical trials show acid blockers work no better than a placebo and can actually lead to short term and long term side effects. The FDA has not approved PPIs for treatment of GERD in children younger than one year.

The growth of GERD and reflux drugs for babies, infants and newborns. Are parents over-reacting to spit-up and crying?

Are Infant Reflux Drugs Worth the Risks? – An infographic by the team at Colic Calm

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Education before medication, please

What is GERD?

Gastro Esophageal Reflux Disease or GERD, is a digestive disorder that affects the lower esophageal sphincter (LES), the ring of muscle between the esophagus and stomach.

GERD in Infants

Spitting up (GER or “reflux” – the backward flow of stomach contents up into the esophagus or the mouth) is normal in most infants as their immature digestive systems develop. It is self-resolving in almost all infants by 1 year of age. GERD is rare and more serious and occurs when complications from GER arise, such as failure to gain weight, respiratory problems and esophagitis.

Diagnosis of GERD:

There are two main indicators of GERD:

  • Spitting Up“Up to 70% of infants spit up on a daily basis.” Dr. Eric Hassall, Journal of Pediatrics, Vol. 160, No. 2, February 2012.
  • Crying“All infants cry… the median duration of crying is 3 hours per day, and 1/3 of healthy infants crying can exceed 3 hours per day.” Dr. Richard Haber, Parkhurst Exchange. Vol 19, No. 1, February 2011.

However, both of these are NORMAL behaviors for most infants. These tests may assist you with diagnosis of GERD…

  • Endoscopy
  • Esophageal pH
  • Biopsy
  • X-Ray

Proton Pump Inhibitors (PPI’s) and H2 Blockers are the most common medications prescribed by doctors for the treatment of GERD, but fewer than 10% of the infants receiving them had any diagnostic testing. – Journal Pediatric Gastroenterology and Nutrition, Vol. 45, No. 4, October 2007

Babies have been crying and spitting up since time immemorial. But these days many parents ask: Isn’t there a drug for that? ‘Parents often come in demanding medication,’ says Eric Hassall, a pediatric gastroenterologist. Hassall says some parents have picked up on the idea that heavily advertised medicines for reflux in adults can help fussy babies who spit up a lot.”“Second Thoughts on Medicines For Babies Who Spit Up”, NPR, Nov 2011

Explosive Growth of Acid Blockers

The estimated number of infants (<12 months old) with a filled PPI prescription rose from approximately 18,000 patients in 2002 to 145,000 patients in 2009. – FDA Gastrointestinal Drugs Advisory Committee, November 5, 2010

PPI prescriptions dispensed to patients less than 1 year old had an 11-fold increase during an 8-year period from 2002 to 2009. In the 8 years from 2002 through 2009, there was an 8-fold increase in PPI use in children less than 1 year old.

– FDA, Pediatric Focused Safety Review, June 2010
– SDI, Vector One ®: National, Data Extracted May 2010
– SDI, Vector One ®: Total Patient Tracker, Data Extracted May 2010

The results of four clinical trials show that these medicines work no better than a placebo in treating infants with reflux.
The journal of Pediatrics, October 20, 2011
“Second Thoughts on Medicines For Babies Who Spit Up”, NPR, November 2011
Parents who receive a GERD diagnosis are more likely to medicate their infant even though they are told the medication is likely going to be ineffective. “Influence of ‘GERD’ Label on Parents’ Decision to Medicate Infants”, AAP Publications, Pediatrics, April 1, 2013

So, What’s the Harm?

Stomach acid is essential for proper absorption of nutrients. By suppressing stomach acid, acid blockers have a number of potential side effects, especially for infants.

Here are the most common…

Short TermLong Term
Acid blockers reduce absorption of key nutrients:
Headache Vitamin B12 is key to normal brain development
Dizziness Folic Acid helps prevent defects in the brain and spine
Drowsiness Calcium builds teeth and bones
Runny Nose Insufficient production of the enzyme Pepsin can lead to food allergies
Dry Mouth Zinc supports healing and the immune system
Nausea Iron aids formation of red blood cells
Abdominal Pain Magnesium helps maintain normal muscle and nerve function
Constipation Increased risk of infection. As part of the immune system, stomach acid protects infants from infection by killing harmful microbes and bacteria ingested with food.
Difficult Urination


  1. Jonathan Wright, Lane Lenard: Why Stomach Acid Is Good for You: Natural Relief from Heartburn, Indigestion, Reflux and GERD, August 2001
  2. Ryan D. Madanick, MD: Proton pump inhibitor side effects and drug interactions: Much ado about nothing?, Cleveland Clinic Journal of Medicine, January 2011
  3. Whittekin, Martie: Natural Alternatives to Nexium, Maalox, Tagamet, Prilosec & Other Acid Blockers: What to Use to Relieve Acid Reflux, Heartburn, and Gastric Ailments, June 2008
  4. Sherry Rogers, MD: No More Heartburn – Stop Pain in 30 Days Naturally, January 2000
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  10. Sturniolo FC, Montino MC, Rossetto L, et al. Inhibition of gastric acid secretion reduces zinc absorption in man. J Am Coll Nutr. 1991, 10: 372-375.
  11. Office of Dietary Supplements, NIH; Dietary Supplement Fact Sheet on Magnesium