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.
This week, the makers of Colic Calm released a new infographic (below) that highlights the dramatic rise in infant reflux and GERD diagnoses in recent years, as well as the risks and long-term health effects for babies that are taking prescription reflux drugs.
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.
Short Term Long 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 Diarrhea .
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