Reflux Medication

This article is about various medications prescribed for children with reflux.

• Does Your Child Need Medication?
• Types of Medication
• How to Give Medicine?
• Medication Safe?
• End Note
• Works Cited

Does Your Child Need Medication?
You don’t want to give your child medication if she doesn't need it.  That has always been my concern. Part of the problem is you may not be able to obtain an official confirmation that your baby has reflux based on a medical test. Please refer to this link to read about the various tests done to determine if your baby has reflux. Generally most of the tests are not done until the child is older unless there is a serious concern your child is not "thriving" and usually a diagnosis is made based on a description of symptoms rather than a specific medical test. The American Academy of Pediatrics did find that antireflux medication may be overprescribed (Khoshoo). One thing I will note is some babies are classified with reflux when really they have a food allergy such as an allergy to milk. Once those babies are given non-milk formula or the mom, if breastfeeding, excludes dairy from her diet, their reflux symptoms disappear. You will definitely want to confirm with your doctor whether it appears your baby is suffering from reflux or possibly has a food allergy such as an allergy to milk, soy, egg, or peanuts.

On one hand, you don’t want to diagnose your baby with something she may not have but on the other hand, you also don’t want to overlook a medical condition that may be causing the baby pain (and possibly harm). My son’s was a very “happy” baby, he met all milestones, and he was always in the 50th percentile in height and weight so some doctors (including our first one) may have overlooked the fact he was suffering from acid reflux.

Although, I can not conclusively say he definitely suffered from reflux (as no tests were actually done); I’m in agreement with our second doctor that strongly felt he suffered from reflux which is why she put him on medication to help. After starting the medication, I saw improvement in my son eating baby food, from not letting us bring the spoon to his mouth, to eventually eating an entire jar. I never did see tremendous improvement in drinking his bottle until closer to the one year mark. I also subsequently took my son off medication when he was around 12 months and then at 18 months and both times he stopped eating well and exhibited other signs that something was wrong. I saw a pediatric gastroenterologist (GI specialist), when my son was almost two years old since he didn't seem to be growing out of his reflux and most babies grow out of it closer to the 12 month mark. She confirmed again that based on the symptoms described my son seemed to definitely have acid reflux. She increased the medication we were giving him as she said the most important thing is to make sure his esophagus does not get damaged from the acid. In addition, she recommended we do the barium swallow X ray to rule out any other abnormalities that could contribute to the reflux. We did the test and the test was able to confirm that my son's internal system looked "normal" and I was happy to have spent the $200 to learn my son was "healthy" and hope that he will eventually grow out of his reflux.

Overall, you may have to rely on your parenting instinct, discuss with a healthcare professional, possibly more than one, a pediatric GI specialist, and most important listen to your baby to determine if you should put your baby on medication. Please refer to this link for a list of reflux symptoms. If you and your doctor decide to put your baby on medication please remember to use the medication in addition to the other parenting techniques to help your baby with reflux. Also, note that medications like Prevacid and Prilosec may take up to two weeks for your baby to feel relief so don't give up if the first day you administer the medication when you don't see immediate improvement.
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Types of Medication
Remember to not give your child any medication that is not prescribed by a doctor, including the over-the- counter (OTC) antacids. Please refer to the following table for a brief description of some common medications. Also, please refer below for some side effects of some of the medications.

¹Sears 395
²Canani
³Greene
⁴According to Greene, Zantac and Pepcid "are now approved for children, even infants [one month and older]." Other H2 Blockers like Tagamet and Axid are not approved by the FDA for children under 16 and 12 respectively (April 1, 2008). Please refer below for Zantac product information.
⁵According to Greene, Prevacid and Prilosec "are newly approved by the FDA for use in children as young as 1 year old." Other PPIs such as Protonix and Aciphex "are not approved by the FDA for use in children. Nexium is not approved by the FDA for use under 12 years" (April 1, 2008). Please refer below for Prevacid product information.
⁶According to Greene, "[u]recholine has not been approved by the FDA for use in children. Nor has Reglan been approved for use in children, in fact caution is strongly recommended because of increased risk of neurological side effects in children. Erythromycin has been approved by the FDA for children, but not for treating reflux in them."

Generally, Histamine-2 Receptor Antagonists (H2 Blockers) like Zantac are "the first to be used in babies with reflux" since "there has been a lot of experience with these medications." In addition, according to Greene, Ranitidine (Zantac) and Famotidine (Pepcid) are "now approved for children, even infants...." When we met with our pediatrician when my son was 6 months old she recommended starting him on Zantac and if we didn't seem much improvement to then try a Proton Pump Inhibitor (PPIs) like Prevacid.

I had read that Prevacid, although stronger can be more effective, and I didn't see a lot of improvements for my son when he was on the Zantac so we changed to Prevacid. I also discussed medications with a local pharmacist and he said the majority of his pediatric patients were taking Prevacid. I was not happy that Prevacid was not FDA approved for children under 1 years old and I discussed my concerns with our doctor. She said she obviously can't guarantee that it is safe but that infants have been taking the medication and she feels confident in prescribing it for my son. After starting the medication within a week or so, my son was eating his baby food again, when before starting the medication he would clamp his mouth shut and shake his head back and forth when he saw the spoon; definitely not the happy baby with his mouth wide open for baby food. He still didn't drink a bottle as well as he did before he turned 4 months and became a "fussy bottle drinker" but he did seem to drink it better than before we started the medication.

When we saw a GI Specialist, she kept my son on the Prevacid but did increase the dosage. Your doctor may prefer a different medication rather than Prevacid. It seems to vary doctor to doctor. I also know of some infants/ children that take both Zantac and Prevacid. My son seems to do very well on Prevacid alone so I'm happy I don't have to give him another medication on top of that.
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How to Give Medicine?
If you are giving one of the compounded medications like Prevacid or Prilosec, note the following three key points based on my experiences, ideally you may want to find a compounding pharmacy that will mix the medication every 14 days, it is best to give the medicine twice a day, morning and night, and ideally you want to give the medicine before your baby eats. In reference to medications like Zantac, I believe usually it is given two to three times a day. Obviously, make sure you follow your doctor's and pharmacist instructions on the medication that is prescribed for your baby.

I read that a compound medication like Prevacid "generally only lasts 14 days, though some Drs and pharmacists will say 30 days, what is noticed that around the 14 day mark an increase of symptoms occur due to the product becoming unstable. Generally this is related to the effect of flavorings added by pharmacies" (McMahon). A compound medication like Prevacid also needs to be refrigerated. I was able to find a great compounding pharmacy and the pharmacist makes our medication every 14 days. He will make a 1/2 dose each time so he only bills it through insurance once a month. Usually pharmacies like CVS will only make the medication once a month. I called another compounding pharmacy and they said that their tests show the medication is effective for at least a month and so they also only make it once a month. Since, I really like the pharmacist I found and he makes it every 14 days I prefer to stay with him even though it is a bit of a drive for us (well really Erik) to pick up the medication every two weeks.

We also had my son's Prevacid medicine mixed with flavoring until my son turned two (so we used the flavoring mix for 1 1/2 years) and then I figured my son didn't really need the flavoring mix. I'd prefer to not have the added sugar and/or dyes from the flavoring if it isn't needed. My son didn't even seem to notice when we removed the flavoring.

Our doctor initially prescribed one daily dose of 15mg per day of Prevacid. Although, based on my research it seemed that it is best to break up the dosage several times a day. "It has been found that children metabolize PPI's two to three times faster than middle age adults, and thus splitting the does over 2 to 3 times a day gives better results" (McMahon). I confirmed with my pharmacist and he said all of his patients were currently taking the medication twice a day. I discussed with my doctor that I'd prefer to give the medication twice a day and he said that would be fine. Later, when my son seemed to be doing better I weaned him off of the nightly dose and my son's doctor said that was great. Yet, when I saw the pediatric GI specialist, when my son was almost two, she increased my son's Prevacid medication to 20mg per day split between two doses, one in the morning and one in the evening. She felt it was important to give the two doses to make sure we protected his esophagus from damage.

I read that you should give the PPI's medicine thirty minutes before the baby eats. My doctor recommended to try to wait at least fifteen minutes, which doesn't sound like a lot but when you have a crying, hungry infant fifteen minutes can be a long time. The one bottle my son was usually anxious for was the morning bottle so making him wait the fifteen minutes was hard on some days. I tried to immediately get his medication before I even went in his room to get him and then I would try to "stall" by changing his diaper ect to try to wait the fifteen minutes before giving him his bottle after the medication. Then for the evening dose I would try to wait at least an hour after he last ate and at least fifteen minutes before we gave him his evening bottle. It usually worked well to give him the medicine right before his nightly bath.

We always administered the dose of medication in a syringe. Now my two year old son prefers to give himself the medication, after Mommy measures it out for him. Since my son has been taking the medication since he was six months, he thinks it is normal and doesn't put up a fuss to take this or any other medication. I hope that one day my son will no longer have to make Prevacid part of his daily routine.
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Medication Safe?
As discussed above a lot of the medication prescribed to treat infant reflux is not approved by the FDA, at least not approved for children under one year. Ranitidine (Zantac) and Famotidine (Pepcid) according to Greene, are "now approved for children, even infants...." While Prevacid and Prilosec "are newly approved by the FDA for use in children as young as 1 year old" (Greene). We started my son on Prevacid when he was 6 months old so technically the medication was not approved for children his age. I was surprised to find this out on my own, the doctor when prescribing the medication did not tell me the drug was not FDA approved for a child my age.

"Pediatricians routinely use many drugs which are not FDA approved for a particular use or patient population. Often, this is because the drugs have never been systematically studied in children, not because they are known to be especially dangerous to children" (Greene). On the other hand, if the drug hasn't been tested then the "[s]afety and effectiveness in children have not been established" (Greene). After coming to terms that I didn't really have an alternative and receiving reassurance from my doctor I decided giving my son the Prevacid was the best option for him.

I was also concerned about the "large" dose prescribed to give my baby, initially it was 15mg per day for a six month old baby. I read that adults may take a dose of 15-30mg a day so I didn't understand why I would give the same dose to my baby. Based on some research, I found that "PPI's are less weight sensitive then other meds, so doses will depend on symptoms" (McMahon). I also confirmed with my pharmacist that his other patients were taking a similar dosage.

As with any medication, there are potential side effects. Please refer above for more information on the types of medications and descriptions of those medications.

¹Greene (April 1, 2008).
²AAFP
³According to the Zantac Prescribing Information - the "safety and effectiveness of ZANTAC have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of ZANTAC in this age-group is supported by adequate and well-controlled studies in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature…Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established. Safety and effectiveness in neonates (less than 1 month of age) have not been established." Please refer to the Zantac Prescribing Information for information on the dosage for pediatric patients.
⁴According to the Prevacid Prescribing Information “safety and effectiveness of PREVACID have been established in pediatric patients 1 to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis, however, PREVACID was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter, double-blind, placebo controlled study.” Note:  Short-term treatment for pediatric use appears to refer to a period of up to 12 weeks according to the product information. Please refer to the Prevacid Prescribing Information for more information on the dosage for pediatric patients.
⁵Tsou - Study was done on "infants with normal renal function during prolonged aluminum-containing antacid use."

Overall, no one can guarantee the medication is safe for your baby and you may be advised by your doctor to give your baby medicine that is not FDA approved. According, to the Prevacid Prescribing Information, their study indicated that Prevacid was not effective in patients with symptomatic GERD 1 month to less than 1 year of age. In addition, the Prevacid Prescribing Information indicated the medication should be used for short term use, up to 12 weeks. I am not thrilled about these statements, especially since my son started taking the medication when he was 6 months old and has been taking it for the past year and 1/2. What I am happy about is that the medicine does appear to work for my son. He went from not letting us give him baby food, crying hysterically when he saw his bottle to happily eating baby food (even if it was in front of a baby dvd) and drinking a few ounces of his bottle. I've tried to take him off the medication several times and every time he stops eating well and most recently he started acting like a "clingy" baby and didn't want to go to the gym daycare which he previously loved. Soon as I put him back on the medication, he started eating well again and once again loved the gym daycare.

I do hope that my son won't have to take Prevacid for much longer but for now, I believe it helps him enjoy food, something some of us take for granted.
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End Note
I’ve always been a minimalist on medication.  I rarely take any form of medication myself. On the other hand, sometimes medication is needed.  We live in an advanced society and based on my opinion it would be silly to not take advantage of some of those benefits.  Thus, when it comes to a necessary antibiotic to cure an infection or in this case providing relief to my son so he could eat then I felt it was necessary to give him the medication.  In general, I’d prefer to not to have given him any medication but based on what I've been advised from my son's pediatrician and his GI specialist, and my general observations I believe I'm making the best decision I can for my child.

In the end, I will not know if I definitely made the correct decision, but the thing I do know is that I have a little boy that appears to be thriving, eats extremely well by himself, and gives me lots of smiles and laughs each and every day.  I wish you the best of luck finding the best course of action for you and your family.
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Works Cited

American Academy of Family Physicians (AAFP). "Gastroesophageal Reflux Disease: Diagnosis and
Management." American Family Physician. 1 March 1999. 17 June 2010
<http://www.aafp.org/afp/990301ap/1161.html>.

Canani, Roberto Berni, et al. "Therapy With Gastric Acidity Inhibitors Increases the Risk of Acute
Gastroenteritis and Community- Acquired Pneumonia in Children." Pediatrics: Official Journal of
the American Academy of Pediatrics. 117 (2006): e817-e820. 14 June 2010
<http://pediatrics.aappublications.org/cgi/content/full/117/5/e817>.

Greene, Alan M.D., and Cheryl Greene. "Gastroesophageal Reflux Treatment." drgreene.com.
1 April 2008. 16 June 2010
<http://www.drgreene.com/qa/gastroesophageal-reflux-treatment?pagination=show>.

Khoshoo, Vikram, et al. "Are We Overprescribing Antireflux Medications for Infants With
Regurgitation?" Pediatrics: Official Journal of the American Academy of Pediatrics. 120 (2007):
946-949. 15 June 2010 <http://aappolicy.aappublications.org/cgi/content/full/pediatrics/120/5/946>.

McMahon, Rachel. "Omeprazole (Prilosec) for Treating Infant Reflux and GERD."
InfantRefluxDisease.com. January 2007. 17 June 2010
<http://infantrefluxdisease.com/infant_acid_reflux/prilosec-omeprazole.php>.

Prevacid Prescribing Information. 17 June 2010 <http://www.tpna.com/products/default.aspx/pi.aspx>.

Sears, William M.D., Martha Sears, R.N., Robert Sears, M.D. and James Sears, M.D. The Baby Book:
Everything You Need to Know About Your Baby - From Birth to Age Two. New York: Little, 2003.

Tsou, V. Marc, et al. "Elevated Plasma Aluminum Levels in Normal Infants Receiving Antacids Containing
Aluminum." Pediatrics: Official Journal of the American Academy of Pediatrics. 87 (1991): 148-151.
17 June 2010 <http://aapublications.org/cgi/content/abstract/87/2/148>.

Zantac Prescribing Information - Zantac oral for US residents. 17 June 2010
<http://www.gsk.com/products/prescription-medicines/zantac.htm>.

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Last updated: June 2010