I believe that Nexiam (and other proton pump inhibitors) are being overprescribed in private practice. It might have become a fashion drug, being conveniently packaged in the small doses used in young infants. Recent medical literature does not support this phenomenon of widespread non-restrictive prescribing of proton pump inhibitors for infants with gastroesophageal reflux. This is mirrored in the current recommendations from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). In fact, we might be doing more harm than good.
Why the fuss? Decreasing the stomach acid might have consequences : 1. Increased risk of infection : intestinal infections (especially), upper respiratory tract infections, pneumonia and urinary tract infection. 2. Gastric and small intestinal bacterial overgrowth with a disturbance in the establishment of a healthy microbiota. The role of a healthy microbiota in health and disease, digestion, immunity and allergy prevention is an active field of scientific study at present. 3. Iron, vitamin B12 and magnesium malabsorption with associated deficiencies of these. 4. Negative impact on bone health with a risk of later childhood fractures. Listed other noteworthy potential side-effects of proton pump inhiitors like Nexiam include hepatitis (inflammation of the liver), interstitial nephritis and chronic kidney disease (inflammation of the kidney) and pancreatitis.
"Use of proton pump inhibitors (PPI) is discouraged in infants, except for those with endoscopically documented moderate to severe esophagitis, because of limited efficacy and increased risk for some infectious, metabolic, and nutritional disorders. In a new retrospective database study of over 850,000 children, proton pump inhibitor use prior to one year of age was associated with subsequent fractures during childhood; increased risk was seen with both earlier and prolonged duration of PPI therapy. These findings are consistent with studies in adults showing a link between PPI use and osteoporotic fractures and provide an additional rationale for avoiding or minimizing PPI therapy in infants whenever possible." Uptodate.com, updated August 2019
Why is it prescribed so easily? There is a persistent belief that crying in a young baby might be related to the discomfort caused by acid reflux. Doctors probably feel obliged to try something that might potentially make the crying baby more comfortable. It is difficult to prove or disprove that a baby is or is not troubled by his or her reflux. Young babies are even prescribed Nexiam for "silent reflux" (where you don't see any spitting up, passive flow or vomiting of milk in-between feeds). This situation opens up the door for unnecessary and prolonged proton pump inhibitor medication. Even a diagnostic trial of proton pump inhibitor therapy for a few weeks (to diagnose symptomatic reflux) is not supported by the current ESPGHAN guideline.
"Several randomised trials and a systematic review concluded that proton pump inhibitors are not valuable in infants with irritability or regurgitation, because they do not improve symptoms as compared with placebo". Uptodate.com, updated August 2019
"..., The more difficult subgroup of patients is the group of infants presenting with fussiness, crying and arching with or without spitting but who otherwise are thriving. In this population. there is often intense pressure by families to start anti-reflux therapies or pursue diagnostic testing because of the perceived severity of symptoms. In the absence of warning signs, diagnostic testing and/or therapies including acid suppression are not needed if there is no impact of the symptoms on feeding, growth or acquisition of developmental milestones." ESPGHAN guideline, 2018
Most babies will have reflux in the first few months of life at least. Many settle by four months; up to 12 months is still considered normal. With regular feeding neutralizing stomach acid, non-acid reflux episodes are common (especially shortly after feeding) and not bothersome to a baby.
Is Infant Gaviscon an alternative? No. It is intended for short term (days) use only. The chronic use of antacids like Gaviscon is not recommended due to adverse effects again on bone health (hypophosphatemic rickets) and aluminium toxicity in children with kidney disease. What about other medications? Motilium (prokinetic) : not recommended. Erythromycin (prokinetic antibiotic) : not recommended. Zantac (histamine antagonist) : could be beneficial with endoscopically(camera)-confirmed ulcerative esophagitis and gastritis, but is not available. Ulsanic : no clear benefit as yet. We should not be prescribing these medications easily.
What are the recommended conservative measures one should rather try? 1. Don't be overly concerned. Gastroesophageal reflux is normal and resolves in 98% of infants with gastroesophageal reflux before 12 months of age. Warning signs of pathological or an abnormal level of reflux are : failure to gain weight, blood-stained vomit, regular chest infections and episodes of choking/struggling to breathe related to an episode of reflux. 2. Feed smaller volumes more regularly. 3. Thicken baby's expressed breastmilk or formula with rice cereal or oat cereal or, if only on formula, try an anti-reflux (AR) formula, like NAN AR 1 or Novalac AR 1. 4. It could be a manifestation of protein allergy. For breastfed babies, mom could attempt a 2-4 week trial of dairy exclusion. For formula-fed babies, an extensively hydrolysed formula like Pepticate could be tried. 5. If someone smokes at home, stop smoking. Passive smoke inhalation promotes reflux in your baby.