Gastroesophageal Reflux Treatment

Dr. Greene, our pediatrician prescribed Propulsid and Zantac for a case of infant reflux. My baby is only six weeks old. I’m concerned about any possible side effects. Is this a common prescription for infants diagnosed with reflux? Are there other alternative treatments?
Hamoon J. Hedayat – Director – Informix Software, Inc. – Rockville, Maryland

Gastroesophageal Reflux Treatment

Dr. Greene’s Answer:

Your concerns are quite valid. At the time of your question, Propulsid and Zantac were two of the most commonly used prescriptions for babies with reflux – even though neither of them had been approved for this use by the FDA. Later research led to one of one of them gaining approval after being shown to be safe and effective. The other was recalled, after being found to be dangerous.

I’ll answer your question about side effects, discuss other treatment options, and address the important issue of using drugs that have not been approved by the FDA for children. But first a few words about reflux itself.

How do you spell relief?

If you’ve ever experienced heartburn or acid indigestion, you are familiar with the dull, burning ache produced when acid sloshes up out of the stomach into the esophagus. This sloshing is called gastroesophageal reflux.

Babyhood is a time of spit-upping. Since the sphincter at the top of the stomach is often loose, many babies spit up milk out of their mouths or noses. In otherwise healthy, happy babies who are growing well, the spit-up is mostly milk, rather than stomach acid, and nothing needs to be done (except a lot of laundry!).

In some babies, though, the acid makes the lining of the esophagus tender, red, and swollen. They might arch their backs in pain. The acid can also be inhaled into the lungs, irritating their sensitive linings. These children might not gain weight well, or might cry and cry from discomfort. Some might develop a chronic cough, wheezing, hoarse voice, or recurrent pneumonia. A few even stop breathing (apnea) to try to protect their lungs. All of these children deserve some relief from their reflux.

Usually the first place to start is with looking at how the baby is fed. Decreasing the volume and increasing the frequency of feedings is sometimes enough to deal with reflux. If the baby is already drinking from a bottle, thickening the feedings with rice cereal is an option to be discussed with your physician. This can mechanically reduce the amount of milk sloshed back up the esophagus. Some studies suggest that this decreases both spitting up and crying in babies with reflux. However, this does provide extra calories to your baby, and it may also make it harder for your baby to know when he or she has had enough to eat.

Food allergies may also cause reflux. The most common culprits are cow’s milk and soy proteins in formulas. Foods in mother’s diet can also affect breastfeeding babies. Cow’s milk is the most common cause of this, but other foods such as soy, egg, and peanuts could also be a problem. For most babies, I prefer briefly trying to feed the baby without these exposures to see if this solves the reflux problem before trying any medication. I suspect that tobacco, coffee, and caffeine in breastmilk and secondhand smoke in the air also worsen reflux in babies, but I have not seen proof of this.

Because reflux is usually a mechanical problem, and because babies can’t adjust their position as well as you and I can, positioning is an important part of reflux treatment. Sitting usually is the worst position for reflux. Minimizing the use of carriers and swings that keep small babies in a sitting position makes a big difference for some babies. When the baby is awake, carrying the baby upright (especially just after a meal) and encouraging spending time on the tummy are associated with the least reflux for most babies. Babies should not be put to sleep on their tummies, but tummy-time is great for babies when they are awake. Because of the angle of the connection between the esophagus and the stomach, both the upright and “tummy time” positions use the force of gravity to minimize the chances of food and acid refluxing up the esophagus.

A number of medicines have been used to treat reflux.

Antacids come quickly to mind. Although these seem gentle, those available in liquid form today usually rely on magnesium or aluminum. These silvery metals could cause diarrhea or constipation in babies, and their long-term effects are not well understood. If it is absolutely necessary to use one of these, I prefer magnesium to aluminum.

Another class of medicines, called H2RA’s (H2-Receptor Antagonists), decrease acid production in the stomach. Many of them are familiar because of their use in treating reflux or peptic ulcer disease in adults. They do not decrease the reflux itself, but make the sloshed liquid less acidic, and thus less likely to cause irritation. These medicines commonly used in children include cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and one of the medicines you asked about, ranitidine (Zantac). Tagamet is not approved by the FDA for children under 16 and Axid is not approved by the FDA for children under 12. Pepcid and Zantac are now approved for children, even infants, although they were not at the time of your question. Zantac is a strong drug. It has brought relief to many babies. It is well tolerated by most children. Headaches, sometimes severe, are the most commonly reported side effects in those old enough to describe them. The most serious side effects, heart rhythm abnormalities, can be caused by any medicine in this class – but they are quite rare. Because there has been a lot of experience with these medications, they are usually the first to be used in babies with reflux.

Proton pump inhibiters are a more recent development. They are more powerful at blocking acid production. You might recognize some of the names from television ads. Those commonly used in children include esomeprazole (Nexium – the Purple Pill), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (Aciphex). 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. Prevacid and Prilosec are newly approved by the FDA for use in children as young as 1 year old.

Another class of medicines, called prokinetic agents, are supposed to help speed along whatever is in the stomach, and to tighten the valve at the top of the stomach so acid is less likely to slosh up. Propulsid falls into this category, but thankfully is no longer used. It was extremely popular for several years, but when looked at carefully was found to have killed 80 of those taking it. Other prokinetic medicines used in children include bethanechol (Urecholine), metoclopramide (Reglan), and the antibiotic erythromycin. Urecholine 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.

You will have noticed that many of these drugs have not been approved by the FDA for use in children. “Safety and effectiveness in children have not been established.” Do they really work? Are they really safe? We really don’t know. Most of what we do know about both drugs has been learned from their use in adults. This does not mean that your physician was wrong to prescribe them. 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.

Of the two unapproved drugs that your physician chose, Zantac went on to be approved after research in children found it to be both safe and effective; Propulsid was recalled after it was found to be dangerous.

As of the time of your question, of the 80 drugs most commonly used to treat newborns and infants, only 5 had been tested and approved for use in children! (American Medical News, June 2, 1997) The situation is now improving, but we still have a long way to go. Because children of each age represent a small market share, because tailoring trials to specific age groups is very expensive, because parents are understandably reluctant to let their children participate in clinical trials, because pharmaceutical companies are reluctant to risk liability for side effects, and because many of us don’t take little children and their needs seriously — our knowledge of the safety and effectiveness of drugs in small children is unconscionably inadequate.

In the current environment, prescribing unapproved drugs is common and often vital. But let’s not settle for the current environment. Let’s encourage the FDA and the pharmaceutical industry to learn more about the effects of commonly used drugs on children.

In the meantime, I would only use these excellent medications if the symptoms from the reflux are severe. Last week a baby I take care of was proven to have episodes of reflux that produced prolonged apnea spells (not breathing) and periods of slow heart rate. For this baby, the benefits of strong medicines clearly outweigh the risks. For most babies, though, the impact of reflux is much less serious

I’ve begun to hear about doctors who prescribe Zantac for almost any fussy baby. This is unwise. While side effects are uncommon, this is a strong drug that alters the normal secretions of the cells of the stomach wall. I agree with thoughtful use of Zantac. It should not be dispensed like candy.

The human body is amazing. Even as we consider the options for treating reflux, your baby is already busy doing the real work. Silently, the muscles mature and coordinate. The great majority of babies with reflux cure themselves, with nothing but a tincture of time and some thoughtful, gentle relief.

Dr. Alan Greene

Dr. Greene is the founder of DrGreene.com (cited by the AMA as “the pioneer physician Web site”), a practicing pediatrician, father of four, & author of Raising Baby Green & Feeding Baby Green. He appears frequently in the media including such venues as the The New York Times, the TODAY Show, Good Morning America, & the Dr. Oz Show.

  1. Juju

    Prescription drugs should never be a first choice. These drugs are dangerous especially for babies and children. Doctors are practicing & experimenting on people and have no idea what these drugs are doing to people. The drugs haven’t been on the market long enough to know anything. With all the processed foods we are eating babies are now starting to suffer greatly with stomach issues. The best thing to do is find natural or organic alternatives to drugs. Just remember that something natural may take a little more time to see results. I fell for the doctor’s advise when I was younger and my son ended up addicted to a steriod drug which took over a year for the withdraw effects to subside. His retarded doctor had no clue what was happening. I am now allergic to all antibiotics and fake sugar like high fructose corn syrup. It’s just a matter of time before we all are allergic to these drugs. Why?? Because drugs were never meant to be created or entered into our bodies.

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  2. Cornel

    Our newborn has been on Zantac since he was 2 weeks old.
    He’s 5 weeks old now and we will stop administration.
    Our honest and not so polite opinion… a retarded drug that has caused our baby more pain than before, no sleep,constipation, gas, irritation and many baby tears.
    As soon as we took him off it, he calmed down, we added a ounce of fresh Chamomile tea to his formula, not a extra ounce just substituted the water.
    And there he went : poop like a normal baby, gas free and little fussiness.
    We still have to battle the reflux, but is not as bad as to the Zantac side effects. Terrible, terrible.

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    • Vanessa

      My son is 8weeks he is on Zantac and Prilosec I think it’s a little much for such a small child. The issue is he has these episodes where he has excess saliva coming from mouth and nose to where he cannot breathe. My husband has to hit him in his back and we have to use a bulb aspirator to get the saliva out. It happens randomly they say it’s reflux.
      We were in hospital for 2 days so they can monitor him also upper GI test was performed and stomach ultrasound everything was negative. I don’t understand.
      Sometimes I think it’s. Side affect from Zantac as its when it all started.

      I don’t know what to do as a mother should I stop all meds to see improvement or if condition worsens?
      Help someone would be great to hear other opinions.

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      • Vanessa,

        These medicines are widely prescribed, but as Dr. Greene says, “I would only use these excellent medications if the symptoms from the reflux are severe.” It is always wise to discuss a change in medication with your child’s doctor before making it.

        Best,
        @MsGreene
        Co-founder & Executive Producer DrGreene.com, Mom

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  3. sara

    My son is a week old he was put on axid a few days ago. He acts like his pain is getting worse. Should i change his meds? He is soley breastfed. How long does it take for the medicine to work? Should i stop the medicine? My other daughter had it and took zantac.

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  4. Liza

    My 7 week old daughter is on Zantac 0.5 ml. It was just increased from 0.266 ml. Is 0.5 ml to much for a 8 lb 13 oz 7 week old baby? She seems more in pain now than before when she was taking less.

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    • Venus Cardinale

      When my premie baby was 2 month old she had strong reflux and the Dr put her on Zantac 0.5ml the second day after taking it my LO started to sweet cold, shake and act like hyper, cry spits up much and like a shot… So I stop the Zantac, the side effects was worth than the reflux symptoms. She is 6 months old now, she still have reflux but since I stopped Zantac the pediatrician put her on Prevacid 14mg. I dont need prescription for that and I just put the powder from the capsule in 1oz of formula every morning 1 time per day and that medication work perfect for her, no sides effects. Im sorry I guess I make it too long, but what I wanted to said is if your baby is guetting wors I would stop Zantac and ask the pediatrician to change te medication all the times necessary until find the one works for your baby. She shouldn’t be suffering if she is taking medication it soppouse make her better and happy. Good luck.

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  5. Mariann

    Our son has had three incidents where he stopped breathing and has given us quite a scare. The doctors at the hospital, our pediatrician, and the pediatric gastroenterologist we saw, all say they are not sure of the cause, but since he does have reflux, it could have been that. It is very unsettling not knowing for sure what is causing these incidents. You mentioned a baby in your care with apnea spells, how were you able to know for sure the reflux was the cause of the apnea?

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    • Venus Cardinale

      My baby born at 34 weeks and she had reflux and apnea too, also her heart rates low when she the apnea episodes… With the time the apnea episodes was less and less, now she is 6 month old and sometimes if she is asleep and if she is in the car seat for example or in a position where her neck is not straight she will have some shorts apnea episodes (like for 5 seconds) Is just matter of time until they grow up and their organs mature, my advice is always check him breathing special during the night.

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  6. Betty

    Hi,
    My daughter is two weeks old and she suffers from reflux (I know the symtoms because my oldest son who is now 8 years old, suffereed from serious reflux when he was a baby and my daughter now has the same symtoms).
    She cries a lot from it and I wanted to ask if I can give zantac to a two week old as well and if yes, if the calculation of the dosage (by the weight) is the same way as for a 1 month old.

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    • Hi Betty,

      As with many drugs, our thinking changes over time. Originally it was thought Zantac helped babies with reflux because, after all, it helped adults. In the past few years double blinded studies have been done in babies and it was determined that both the babies who received Zantac and those who did not recovered at approximately the same age. Since Zantac has side effects, it is now thought that it’s not best to give to babies.

      Hope that helps,

      @MsGreene

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      • Betty

        Hi,
        Thank you for your quick response.
        I am quite estonished and saddened by what you wrote.
        I know that it doesn’t resolve the problem faster and I don’t expect it to do so but it does give the baby a relief and let him be a normal baby with a relaxed mother (that is sometimes much more important even though the Zantac can have side effects by the studies you wrote about) .

        I have 4 children now and my oldest son suffered from reflux (my other two didn’t but now my baby does). I cannot tell you enough how difficult, depressing and painfull it was for my oldest son and for me as well back then (he is now 8 years old). Once we were introduced to Zantac (we only heared about it when he was 2 months old) everything changed. I was so releaved and happy to see my baby not going through so much pain all the time and the intensive crying and screaming stopped. I could finally enjoy my mother hood and see my baby also happy sometimes and not only crying and suffering.
        Reflux can be very hard and a baby with painfull reflux is really a tremendous suffering for the baby as well as the mother. I remember myself crying together with my son because he was screaming all the time, and I didn’t have the means to help him. I couldn’t hold him normally, nor smile or play with him.
        I am writing all that because Zantac changed our lives back then and I thank the doctor that subsribed us Zantac untill this day.

        I personally didn’t recognise any side effect and so didn’t the other mothers I know who gave Zantac to their children, but even if there are as you wrote that studies have determined, I as a mother of 4 can say that sometimes you have to look at the side effects and really decide if you want to let you, your family and especially your baby suffer as much or maybe it is worth to try the Zantac. Of course it depends on each baby individually and on how severe the Reflux is, but sometimes letting the baby suffer is much much worse then the side effects.
        I just want young mothers with baby’s who have severe reflux know, that there is a way out and there is a way to let you enjoy your baby and relax (because that is something I didn’t know in the beginning untill I heard about Zantac). This is why it was important for me to write all the above.

        In any case, I am giving my baby Zantac, I just wrote to you to know if the calculation of the dosage (by the weight) under 1 moth is the same as the calculation above 1 month but I understand that you don’t think it is best to give Zantac to babies.

        With Kind Regards,
        Betty

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        • Betty,

          All children are different. If you found relief for your children and they didn’t experience side effects, this might be good for you and them.

          I recommend you contact your doctor for dosage. Unfortunately, we can’t diagnosis or provide specific treatment plans on this site. All we can do is education that is general in nature.

          All the best,
          @MsGreene*

          *To be clear, I am not Dr. Greene. I am Ms. Greene. I co-founded DrGreene.com with my husband. He’s the pediatrician. My advice is only as a mother.

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  7. Victoria

    My 3 year old daughter has been on lansoprazole since she was 6 weeks old. By the time she was 2 she was given rantidine also. After many different tests, we have been told that she is now severely constipated. What can we do to help her? She never complains about pain so we never know if she’s hurting. Is this all caused from meds?

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  8. Cadence

    I have a question. My son is four months old and has just recently been put on Zantac. My question is this: Should he spit up immediately after taking the medication, should I immediately repeat the dosage or just wait until the second dose of the day comes up? I don’t want him to be in pain while he eats the entire day, but I also don’t want to over-medicate either.

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    • Mary

      Hi Candence,
      I’m also having the same problem with my 3 month old son too. Everytime I give him the medication he either spits it right away or with milk after a feeding…I wonder if this is normal…?

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      • ccprim

        ask the pharmacist to add flavoring to it. Also add it to his milk.

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    • Jami (RN)

      Because you can never be certain of how much the child took in, you should never repeat a dose of any medication immediately. It is wise to wait until his next dose of the medication rather then risk giving too much. This goes for antibiotics, Tylenol etc. Hope that helps!

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    • Coreen

      Zantac is only to be given 2 x a day at most, 12 hours apart. Only give it to him as directed, it is not like tums or something where you just eat one and feel better. You’ll notice an overall difference within a couple.days if it’s helping. My son is 8 months been on it since 1 month and he still spits up all the time on it. The difference is he isn’t screaming when it happens and the pain is not there anymore. Good luck!

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  9. Rose villalbos

    Hi I’m rose
    I have a daughter that’s 4 years old. Two months ago I notice that when she goes to sleep, she wakes up crying and tells me her tummy hurts and she vomits. After that she goes back to sleep. I don’t know if the milk is getting her sick or what. I’m so stressed out. I don’t know what to do. I took her to the doctor and they gave ranitidine. I hope it works. The doctor told me she has a lot of acid in tummy. I would like to hear some comments.

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  10. Dinar

    Thank you for such a clear explanation Dr. Greene
    My baby is 12 weeks old and has been spitting and vomitting a lot since he was 2 weeks old. When he was around 8 weeks old, he did projectile vomit with blood. But he wasnt distress or anything. The pediatrician said he had tear in his eschophagus because he has been vomitting acid for a while. They gave us option to put him on reflux medication or let it heal itself. We chose to just left it alone because, again he is such a happy baby. But in the last week or to he had gained weight poorly, and had trouble with feeding (I am exclusively breastfeeding and he looked like in pain when feeding in the last week, by pulling himself from the breasts very often, and moving so much during the feeding) but still a happy baby. We decided to go to GP because we are concerned about his weight. The GP prescribed him a 10 ml Esomeprazole, but he said just to use the 5 ml one which is in capsule or something. I havent got the prescription yet, want to know more first. In your article above said that the medication is not suitable for infant under 12 months.What do you think about medication that my GP prescribed for my baby?. Should I stop consuming cow’s milk for a little while?

    P.S : I have tried different things to reduce the reflux, such as keeping the baby upright after feeding, burp him frequently, feeding more frequently long time ago and still doing it but none of them worked.

    Any answer would be appriciated.

    Thank you,

    Best regards,

    Dinar

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    • Dinar

      Hi Cheryl,
      never mind :-).
      Any idea about what should I do related to my comment?
      Any help would help a lot.

      Thanks

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    • Nicole Lynn

      Can you discuss the neurological side effects of Bethanachol?

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    • Venus Cardinale

      Had you tried to take your breast milk put it in a bottle and add a little bit of rice cereal? That works for my baby. Her pediatrician told me to thicken her milk a little bit and it helps a lot with reflux, also after eat if he go to sleep lay him on the left side or you can try to elevate just a little bit his crip so he sleep with his head a little bit up. This small tips helped me, I was desperate too. Now my baby is 6 months old. She still taking lansoprazole for her reflux since she was 2 months and it worked perfect. No sides effects.

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      • Sierra Graham

        Hello, How young did you add cereal to your babies milk? I am considering doing the same soon but dont wanna add it too early. My baby is just a month. I wanted to wait until shd was 2 mnths at least

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