Patients
Patient Education
MARCI-kids wants parents of children with reflux to know that our goal is to help you educate yourself. Many parents have approached us with questions, concerns, and doubts. This page is designed to answer those.
If you have any questions that you would like to add, please send them to info@marci-kids.com.
Why are the MARCI-kids recommended PPI doses so different from what my doctor recommends?
The FDA has approved 10mg/day of Omeprazole for a child under 20kg, and 15mg/day of Lansoprazole for a child under 30kg. According to the CDC, even a 12-month-old child at the 97th percentile of weight falls into both of these categories (see graph at right). That means that a 1-month-old and an 11-month-old would get the same treatment. We at MARCI-kids realize that not every child under 12 months is the same, just as children and adults are not the same. We have been working to develop an appropriate dosage for children of all weights and ages.
In reality, though, PPI doses that doctors prescribe for children varies significantly (see chart below).
Statistically speaking, a simple way to look at a dosing regimen for a specific population (say, children) is to determine what dosage would cover 84%* of that population. According to the Barron study, that dose is 1.84mg/kg/day for omeprazole, and 3mg/kg/day for lansoprazole.
Because PPIs are such safe drugs and there are no known side effects with giving a slightly higher dose, it is best to err on the side of the drug rather than the side of the disease, that is, to dose on the higher end of the scale.
*This is the mean plus one standard deviation
If my child has asthma and ear infections, but no other typical signs of reflux, does s/he have silent reflux?
Silent reflux is reflux that not only lacks exhibiting traditional signs, but exhibits no signs at all. This includes the typical signs like discomfort and arching when eating, excessive crying, and frequent vomiting, but also atypical signs such as asthma and ear infection. Silent reflux is simply reflux that exists without showing any signs or symptoms. You don’t know you have it. Few children have silent reflux; it is more common in adults.
If your child’s signs include asthma or ear infections, s/he may have extra-esophageal reflux, or atypical reflux. This is reflux that extends past the esophagus. See Disorders or What is EER? for more information.
Why do H-2 blockers work at first and then stop working?
H-2 blockers are a type of drug called receptor blockers. The body can often build tolerance to this class of drug.
The job of any receptor blocker drug is to physically block a molecule from telling the body to start doing something. In the case of H-2 blockers, the drug blocks histamine type 2 molecules from telling the body to start making stomach acid.
The normal process is for an acid-stimulating molecule to fit like a puzzle piece into a specific receptor (found on cells in the stomach wall), triggering stomach acid production to begin.
When an H-2 blocker is present though, it also fits into that receptor, but without triggering a reaction. Now that the receptor is occupied by the drug, the acid-stimulating molecule has nowhere to go, and can no longer tell the body to start acid production.
This usually works well in the first few days, but often loses effect after one to two weeks. The body develops tolerance to the H-2 blocker by building more and more receptors. The drug still fills many of the receptors, but now there are new receptors to fill, and the acid-stimulating molecules are filling them.
If PPIs are so effective, then why did my doctor give my child an H2 blocker?
H2 blockers have been around longer than PPIs, which to some means reliability. In general, the longer a drug class (such as H2 blockers) has been in existence the more that is known about the drugs in that class.
PPIs have been around over 15 years, though, and are actually safer and more effective than the H2 blockers. According to the FDA (Food & Drug Administration), PPIs are superior in efficacy to H2 blockers for treating acid related disorders.
I’m worried about the long-term effects of the MARCI-kids recommended dosage of PPIs. Could I be doing more harm than good down the road?
Side effects are unintended effects that occur while a drug is traveling through the bloodstream. PPIs are a type of pro-drug, that is, a drug that is inactive while traveling in the bloodstream. PPIs become active only at the parietal cell (the cell that produces stomach acid). They therefore have little to no side effects.
In some individuals, taking PPIs can affect the uptake of vitamin B-12 and iron. Talk to your doctor to find out whether s/he thinks the B-12 and iron levels should be monitored, especially in the case of long-term use of a PPI (more than one year).
Are PPIs approved for children?
Omeprazole is approved for children over 24 months old, while Lansoprazole, and Esomeprazole are approved for children over 12 months. Although not approved for infants (children under 12 months), the prevalence of PPI use in infants is growing (see figure below left). The greatest need for PPI use in children is during the first year. As you can see from the graph below, the majority of PPIs prescribed for infants are given between the second and seventh months of age.
Why are doses for children and adults different?
In general, children metabolize drugs more quickly than adults, that is, a drug leaves their system more quickly, necessitating a higher dosage to get a desired effect.
“The apparent clearance of omeprazole, lansoprazole and pantoprazole appears to be faster for children than for adults. A higher metabolic capacity in children as well as differences in the extent of PPI bioavailability are most likely responsible for this finding. This may partly account for the need in children for variable and sometimes considerably greater doses of PPIs, on a per kilogram basis, than for adults to achieve similar plasma concentrations.” -from Catherine Litalien, Yves Theoret and Christophe Faure; Pharmacokinetics of Proton Pump Inhibitors in Children [Clin Pharmacokinet 2005; 44 (5): 441-466 REVIEW ARTICLE 0312-5963/05/0005-0441]
Many drug companies shy away from studying their drugs for use in children because it can be a lengthy process, and one that might not be worth the money, time and resources.
Before getting approval, the drug company must first complete clinical studies. This can often be more difficult in children than in adults, if for no other reason than the fact that younger children can’t communicate as clearly how they are feeling.
The FDA rewards drug companies with incentives for going through the process to approve a drug for pediatric use (e.g. extending patent protection for 6 months). There are two ways to do get a drug approved by the FDA for use in children:
determine what dosage is appropriate for different ages of children, or, show that a drug has a similar pharmacokinetic profile in children as in adults. The latter is a much simpler process, so many drug companies take that option.
The key here is in understanding what pharmacokinetics involves. Pharmacokinetics is the study of the movement of medicines into, through, and out of the body, and is determined by:
Of the items listed, all but half-life are similar in adults and children, leaving the claim easy to make that, in general, adults and children do have similar pharmacokinetic profiles, when in fact they don’t. Because the half-life in children can be 3 times shorter than that of an adult, there is a significant difference in pharmacokinetics. It boils down to a matter of terminology: using the general term “pharmacokinetics,” or the more specific “half-life.”
Why am I having such a hard time finding a physician to agree with your dosing?
A simple answer would be that it’s difficult to change what was learned and adopted as true, even as new information becomes available. Often, the latest information a doctor is given on these topics dates as far back as medical school, or is provided by a drug company representative.
Some physicians are hesitant to accept education from their patients or a website. But we encourage you to keep trying! Find a doctor who will listen and appreciate the research you have put into the health of your child.
What information can I give my physician regarding the reasoning behind your dosing?
Our Research page lists numerous articles and studies regarding drug metabolism in children, as well as other new and relevant topics. The Patient Stories page might also give some good insight.
Does MARCI-kids work for the drug company and have a financial interest in recommending higher doses of PPIs/Zegerid?
The MARCI-kids team completes its own research. That is how we are able to share the information on this site with confidence. That research has lead to the development of Zegerid, now sold by Santarus. We encourage this product because we have put the time and resources in to make sure it works for our patients. Financial interest? No. Experience and knowledge to back what we say? Yes!
Why doesn’t MARCI-kids reach out beyond the website to get the word out?
We are always in this process! Dr Phillips often travels to work with other doctors. The team does its own research and publishes their findings. These steps gradually get the word out. Unfortunately, it can take years for new information to get into common use.