FDA Approves Prescription Proton Pump Inhibitor Drug for 1-11 Year Olds

Tuesday, April 15, 2008 by: Teri Lee Gruss
Tags: children's health, health news, Natural News

(NewsTarget) The FDA recently approved the short term use of the proton pump inhibitor (PPI) drug Nexium for children one to eleven years old for the treatment of GERD, gastroesophageal reflux disease. Paradoxically, (www.worstpills.org) , the Health Research Group of Public Citizen recently issued a warning about the epidemic overuse and over prescribing of proton pump inhibitors.

The March 2008 issue of Worst Pills Best Pills Newsletter cites a British Medical Journal editorial which found evidence of "international epidemic overuse of PPIs". The article titled "Avoiding Overuse of Proton Pump Inhibitors (PPIs)" notes that in "2006 alone there were 70 million prescriptions filled for PPIs with sales totaling $10.5 billion" dollars. That is a lot of stomach acid suppression, but does such heavy use of PPIS provide more risk than benefit?

What are the health implications of shutting down stomach acid production in children as young as one year old?

The FDA lists adverse reactions to Nexium in children as headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness.

We all know how many in the mainstream medical community deal with adverse effects of a drug. They prescribe more drugs to treat adverse side effects of the drug. The FDA list of adverse reactions to Nexium could, plausibly, lead to an alarming increase in the number of medications used to treat adverse reactions to Nexium. Not a good scenario for a small child.

Another less known problem with the use of PPIs is that getting off them can present a big obstacle. When a person stops taking PPIs there can be a surge in the production of stomach acid accompanied by increased heartburn, indigestion and reflux. Using PPIs can lead to a vicious and biologically abnormal cycle, a very disturbing scenario, especially for a small child.

What causes GERD? Is it really a disease?

The Merck Manual of Diagnosis and Treatment, used by millions of physicians worldwide, defines the cause of gastric acid reflux into the esophagus as "incompetence of the lower esophageal sphincter." In other words, an anatomical defect of the lower esophageal sphincter (LES) allows the contents of the stomach to move upward into the esophagus where the normally acidic content of the stomach can damage vulnerable esophageal tissue.

In the Pediatrics section of the Merck Manual, PPIs are recommended for the treatment of GERD with the caveat that "long term treatment may be needed, especially because relapse rates are very high without continuous treatment. Also the manual says that a pediatric gastroenterologist should evaluate whether surgery is needed for severe reflux." Therefore, to think that a child diagnosed with GERD can take Nexium on a short term basis as the FDA has approved, appears misleading.

Diagnostic procedures for GERD discussed in the Merck Manual include X-rays, esophagoscopy, esophageal manometry, pH monitoring, the Berstein acid perfusion test, and esophageal biopsy.

Based on this diagnostic and treatment protocol for GERD it is apparent we aren't talking about occasional indigestion, heartburn and reflux caused by eating a poor diet, eating too much, too fast and not chewing well. In its discussion of GERD the Merck Manual describes a serious and uncommon disorder (not a disease) that requires long term use of PPIs and/or surgery.

Outside of medical diagnostic manuals, GERD is frequently described in direct-to-consumer advertising as "heartburn" caused by "excess stomach acid". This lack of continuity in the definition of GERD is troubling because it misinforms people about the true cause of GERD and opens the door for large scale, unnecessary prescribing of PPIs to children. Do you know anyone large or small that hasn't experienced indigestion, heartburn and reflux after eating too much of a bad thing?

Diagnosing GERD as an excess of stomach acid ignores important underlying causes of heartburn and indigestion: overeating of greasy and spicy foods, processed foods, eating on the run without thoroughly chewing food, lying down soon after eating and continually eating foods that trigger heartburn (food allergens).

Stomach acid production is a normal physiological response to these habits and conditions. (See Taking the Burn Out of Heartburn by Leigh Erin Connealy, MD, 3/14/2008 naturalnews.com for an educational perspective on the real cause of heartburn and ways to treat it naturally.)

Is GERD a common condition in children?

According to Jonathan V. Wright, MD, founder of the Tahoma Clinic in Washington and author of Why Stomach Acid is Good for You, GERD is actually a rare disorder. Unfortunately, as the drugs developed to shut down stomach acid have become some of the best selling drugs in the history of pharmaceuticals, GERDS diagnosis has increased.

We are all familiar with the direct-to-consumer marketing of "little purple pills". Clever advertisements lead us to believe that we can overeat a poor quality diet and ignore the presence and ill effects of food allergies and by taking just one little purple pill a day, avoid indigestion and heartburn. What a short sighted view!

In the nutrition text Understanding Nutrition authors Eleanor Whitney and Sharon Rolfes state that if "heartburn is not caused by an anatomical defect of the LES, treatment is fairly simple. To avoid such misery, the person should eat less at a sitting, chew food more thoroughly and eat more slowly. People who overeat or eat too quickly are likely to suffer from indigestion". This text is used in college nutrition programs throughout the U.S. and illustrates the general therapeutic thinking about GERD prior to the PPI sales boom of the last few years.

Zollinger-Ellison Syndrome is a rare hormonal disorder in which a stomach tumor causes excess production of stomach acid. Rare is the key word here but this condition is a possible risk factor for GERD.

Health risks associated with shutting down normal stomach acid production in children

Proton pump drugs very effectively shut down the production of stomach acid by specialized cells in the stomach. Dr. Wright says that proton pump inhibitors like Nexium, Prevacid and Prilosec are "the most potent of the acid suppressing drugs and that just one Nexium is capable of decreasing stomach acid by 90-95% for most of the day".

Shutting down stomach acid production is frankly a severe treatment that puts the healthy growth and development of children at risk. Turning off 90-95% of a child's normal production of stomach acid increases their risks for:

* Food borne pathogenic infections

* Decreased digestion and absorption of protein and protein malnutrition

* Impaired development of bone tissue, skin cells, ligaments, tendons, gum tissue, arterial cells which depend on the normal production of the protein collagen for structural integrity.

* Impaired synthesis of biological proteins including enzymes and hormones. The gastric enzyme pepsin is vital to protein digestion. The hormones insulin and glucagon regulate blood sugar, thyroxin regulates the body's metabolic rate, calcitonin and parathyroid hormone regulation, bone mineralization, and antidiuretic hormone regulates fluid electrolyte balance (the vital acid/base balance of cellular mineral salts including calcium, magnesium, sodium, potassium, chloride, phosphorus, bicarbonate, sulfates, protein and organic acids)

* Food allergies and leaky gut syndrome caused by incomplete protein digestion

* Calcium deficiency accompanied by abnormal bone mineralization

* Iron deficiency with risk for anemia

* Zinc deficiency with risk for impaired immune function

* Folate deficiency with risk for large cell anemia, elevated homocysteine levels and neurological dysfunction

* Vitamin B12 deficiency with risk for pernicious anemia, large cell anemia and neurological dysfunction and asthma in children

This is just an abbreviated list of the health risks of shutting down stomach acid production in children and adults. It illustrates the role that normal stomach acid plays in the absorption and digestion of nutrients, its role in protecting us from food borne pathogens that are on the rise in our food supply. Obviously a physician should have very strong evidence that a child's realized health benefits will outweigh the risks associated with PPIs.

What do parents need to know before they fill a PPI prescription for their child?

If your child's physician prescribes PPI, thoroughly understand what criteria he has based his GERD diagnosis on. Does your child actually have a dysfunctional LES?

* Thoroughly analyze your child's diet and eating habits, with the help of a nutritionist if necessary.

* Look for foods that trigger symptoms in your child and remove those foods from the diet.

* Create a calm and relaxed eating environment for your child.

* Feed your child smaller, more frequent meals if necessary

* Teach your child how important it is to chew their food until it is really mashed up!

* Avoid feeding young children foods that require a lot of chewing before they have the teeth necessary to accomplish this important step in the digestive process.

* Don't let your children eat big meals just before naps or bedtime. Reclining prevents gravity from assisting the movement of stomach content downward, increasing the risk for reflux.

* Excessively fatty foods, onions, chocolate, caffeine and peppermint are thought to be common triggers for heartburn. If your child frequently eats these foods, replace with foods that don't cause problems.

It would be interesting to know if children that frequently eat frozen pizzas along with large quantities of caffeinated soft drinks suffer undue heartburn and reflux. It is such a common meal for young children today, even in many school lunch programs. A meal like this, if you can really call it a meal, is loaded with potential allergens (soy, gluten, casein, corn) grease, spices, caffeine, sugar along with a host of preservatives and unnatural ingredients.

By following some basic nutritional guidelines you may be able to address underlying causes of indigestion and heartburn and spare your child the unnecessary adverse effects of a powerful stomach acid suppressant like Nexium.

AstraZeneca manufacturers the proton pump inhibitors Prilosec and Nexium. Prilosec no longer has patent protection and sales of this drug have plummeted accordingly, but Nexium is still sold under patent protection and is an expensive and profitable drug.

We really have to wonder about the timing of the FDA approval of Nexium for use in children with GERD. There are plenty of over-the-counter drugs on the market that are capable of effectively reducing or ridding the body of stomach acid and they carry similar adverse side effects and the potential for misuse and overuse.

As we learn about the epidemic misuse and adverse side effects of PPIs in the adult population, we now have to be alert to this same unnecessary misuse in children as young as one year old. Thanks FDA.

Sources:

FDA News, Feb.28, 2008, FDA Approves Nexium for Use in Children Ages 1-11 Years

Avoiding Overuse of Proton Pump Inhibitors (PPIs), worstpills.org, Worst Pills Best Pills Newsletter, March 2008 - Public Citizen/worstpills.org is a Washington based non-profit consumer watchdog organization. Like naturalnews.com, they refuse government and corporate funding and advertising in order to present unbiased, independent information to the public.

Over prescribing Proton Pump Inhibitors is Expensive and not evidence based
BMJ 2008;336:2-3 (5 January), doi:10.1136/bmj.39406.449456.BE
(http://www.bmj.com/cgi/content/full/336/7634...)

The Merck Manual of Diagnosis and Therapy, 17th Ed., pp.232-233, 2375

Why Stomach Acid Is Good for You, Jonathan V Wright, MD, pp. 27-31, 55-72

Understanding Nutrition, Whitney and Rolfe, p. 89

Consumers Sue AstraZeneca Over Nexium Ad Campaign (http://www.consumeraffairs.com/news04/nexium...)

(This story provides an interesting overview of how AstraZeneca has marketed Nexium after it lost patent protection and sales of its first PPI, Prilosec)

About the author

Teri Lee Gruss, MS Human Nutrition