Reflux Pharmaceuticals

Omeprazole, esomeprazole (a newer form of PPI) and ranitidine (an H2-Receptor) are the common acid suppressors prescribed to newborns from birth onwards for reflux in New Zealand. Worldwide there are a number of other names these drugs go by which you can read further on. These pharmaceuticals stop acid from being produced in the stomach but without acid, much of digestion is compromised. I have encountered far too many babies, that were prescribed these acid inhibitors, exhibiting the side effects listed below.  Most of the time they have been prescribed higher doses than FDA safety recommendations, and at a younger age than the guidelines state with some newborns on a H2 Receptor and a PPI at the same time. Some might say, this is unacceptable for our newborns well-being.

PPI's and H2-Receptors have many brand names worldwide

For those parents who, on the recommendation of health professionals, have administered acid inhibitors to their newborns, this next bit of information may be upsetting.  If you are one of these parents please remember this as you read; you understandably placed your faith in the hands of your health professional who probably thought they were doing the best they could for you.  You have been the best parents possible by accepting a solution that has been advocated.   I understand the desperation to find something that works, something that stops the crying, that reinstates some kind of sanity back into life, gifting you the newborn and life you envisioned.  You did what any good parent would do.  You tried something that might help and it seemed to because it brought calm.


Doctors Opinions

My research into acid inhibiting medication (Proton Pump Inhibitors PPI’s and H2-Recptors) started in 2011 after liaising with two well-respected New Zealand doctors who insisted the real facts needed to be known by parents.  The doctors, like a growing number world-wide, are strongly opposed to the distribution of these pharmaceuticals for newborns.  They are mortified that these prescription drugs are being pushed as a treatment for GOR/GER and often without formal investigation.1 They have asked to remain anoymonous but say, ‘they are interested in effecting change and prefer to see alternatives prescribed before doctors and paediatricians jump to prescribe PPIs.’

One of the doctors has a complete understanding of a parents’ predicament when dealing with the behaviour of reflux, silent reflux or inconsolable crying.  Her daughter posseted copious amounts of milk, screamed for hours on end and would finally sleep from exhaustion, only to start the cycle again the next day.  During this horrendous, heart-wrenching time, this doctor still refused to place her baby on acid-suppressing drugs.  Her factual reasons:

  • there have been no clinical trials to ascertain the long-term effects on newborns
  • there have been no studies for children under the age of one, and the studies for infants are minimal
  • the trials on adults and rats show too many adverse effects in the use of acid inhibitors
  • without her daughter’s communication she could not be sure if she was experiencing some of the side effects
  • the withdrawal of a PPI causes rebound acid secretion, meaning that her daughter would experience worse discomfort from an excess production of acid when taken off the PPI’s or H2-Receptor Blockers.  A baby’s heightened communication from this acid overabundance during withdrawal suggests that the drug is helping, hence some parents re-administer.
  • acid production has very little to do with the cause of reflux
  • there is evidence that the acid suppression causes increased episodes of pneumonia in patients who use PPIs
  • since acid is such an essential body component, the stomach naturally goes into overdrive to make more and fights the acid inhibitor.  Therefore the dosage generally needs to be increased.


FDA safety and efficacy guidelines

The US Food and Drug Administration (FDA) safety and efficacy guidelines for omeprazole are for the treatment of GORD/GERD (not GOR/GER–reflux or silent reflux) for the duration of eight weeks, and are established for ages 2 to 16 years only. Omeprazole is excreted in breast milk and can potentially cause adverse effects in an infant.

Esomeprazole's safety guidelines state that prescription is only for ages 1 to 17 years or for the short-term use of six weeks for GORD/GERD only.

For ranitidine, the safety and efficacy has been established for the 1 month to 16 year age-group for the treatment of GORD/GERD only and should not be taken any longer than 2 weeks. 

Despite FDA safety regulations, along with the non-inclusion of GOR/GER as one of the uses and the lack of long-term research establishing efficacy for the treatment of GOR/GER with these drugs from newborn to one year, the prescribing of them has significantly increased in many countries for this age group.  ‘Over the past 15 years, many thousands of fussy babies worldwide have been given medicine in the belief that their colic was caused by painful acid reflux, Gastroesophageal Reflux (GER).  From 1999-2004 the use of a popular class of liquid antacid (PPI’s) in young children increased 16-fold and from 2000-2003 there was a 400% increase in the number of babies treated with anti-reflux medicine. This rate of increase has continued—or accelerated—from 2003 to the present.’ 2  In 2013 omeprazole was the third most commonly dispensed medicine in New Zealand. Between 2006 and 2010 the number of prescriptions dispensed for newborns increased from 4650 to 8231. The largest occurred in the age zero to three months (111%) and four to six months (80%) cohorts. This increase is despite a lack of evidence to support the prescribing of omeprazole to infants for symptoms such as rritability and regurgitation associated with uncomplicated reflux (BPAC 2011; 2014). 3,4 

These facts alone mean we should not be giving these prescription drugs to our newborns.  In fact, going from the FDA safety and efficacy guidelines, one could say it is malpractice for a doctor or paediatrician to do so.


The FDA listed side effects of omeprazole and esomeprazole

Common - severe diarrhoea (may be caused by infection in intestines), nausea with or without vomiting, gas pain, constipation and/or undigested food in stools, abdominal pain and dizziness or light-headedness.  In addition, drowsiness, sleep problems, nervousness, headaches, dry mouth and skin rash can develop.  Dietary wise there may be food allergies and iron deficiency.

Other - muscle weakness, chest pain, itching and blood in urine

Serious - rapid heartbeat, shortness of breath, loss of consciousness, seizures, convulsions or hallucinations and fever.  You may also see some swelling of the face or neck, difficulty in swallowing, shakiness or tremors, skin problems such as itching, peeling or hives and redness.  Agitation or confusion may be apparent and tingling in the fingers or toes and/or pain in the calves that spreads to the heels while witnessing swelling of the calves/lower legs.  Other serious side effects include chronic inflammation of the stomach lining and low magnesium levels. 

Pregnant Mothers - Omeprazole belongs to FDA pregnancy category C. This means that omeprazole may harm an unborn baby if used during pregnancy. 

Nursing Mothers - Omeprazole is excreted in breast milk and can potentially cause adverse effects in an infant.  There have been no studies carried out for the effect of the esomeprazole (the new version of omeprazole) when breastfeeding.


The FDA listed side effects for ranitidine

Common – passing wind, constipation, diarrhoea, stomach upset including nausea, abominable pain, headaches and skin rashes.

Other – chest pain, muscle weakness and blood in the urine.

Serious – irregular heartbeat, difficulty breathing, tightness in the chest, fever or chills, swelling of the mouth, face, lips or tongue.  Hives, rashes, yellowing of the skin or eye and itching can occur as can, mental confusion, sore throats, persistent headaches and hallucinations.   You may see a darkening of urine or a change in the amount of urine produced.  Stomach pains, unusual bruising or bleeding can result, as can pneumonia.   

Nursing Mothers – Ranitidine is secreted in breast milk but the clinical significance of this has not been fully evaluated.

Use in Children – Experience with ranitidine preparations in children is limited and such use has not been fully evaluated in clinical studies.  It has been used successfully in children aged eight to eighteen in doses up to 150mg twice daily.  Its safety and efficacy for newborns has not been established. 


If you would like more extensively researched facts about how these pharmaceuticals actually bring calm, subdue the crying and bring more sleep for newborns, please feel free to contact me.


References

1  On the 16th of August, 2007, Marcia Angell, former editor-in-chief of the New England Journal of Medicine and Harvard Medical School Lecturer in social medicine, alleged in the German magazine “Stern” that AstraZeneca’s scientists had doctored their research on the drug’s efficiency.  ‘Caution, Pharma! How the industry manipulates physicians and deceives patients’)  Published in the 16.08.2007 
2   Barron JJ, et al. Proton pump inhibitor utilization patterns in infants. J Pediatr Gastroenterol Nutr. 2007;45:421-7 CrossRef 3   BPAC (2011), Irritable reflux, infants and GORD. Best Practice J. 40:30-37.
4  BPAC (2014), Proton pump inhibitors: when is enough, enough? Best Pract. J. 61:8-15