Proton pump inhibitors for infants

New arguments against prescribing them

  • Regurgitation by infants and gastro-oesophageal reflux are physiological phenomena and do not require medical treatment. Randomised studies into such medical treatment have found no evidence for its efficacy.
  • According to guidelines for paediatricians, PPIs are a therapeutic option for children with gastro-oesophageal reflux disease who respond insufficiently to non-medical options and who expectorate blood or show retarded growth, although there is no evidence for its efficacy from placebo-controlled studies.
  • General practitioners should not prescribe PPIs to infants, and leave this to paediatricians if non-medical measures have insufficient effect.
  • The recently found notable association with future allergies should be an additional argument for paediatricians to be very reticent about prescribing PPIs to infants.
  • PPIs have not been authorised for use in children, so prescribing them to children should be regarded as off-label use. This implies a duty to sufficiently inform the parents (including the lack of evidence for the efficacy of these drugs) and to ask for their explicit permission. Careful recording in the patient’s file is strongly recommended.

  1. Informatorium Medicamentorum 2018. KNMP, Den Haag 2018.
  2. De Gezondheidsraad. Maagzuurremmers voor zuigelingen met reflux(ziekte). Achtergronddocument. 2017;2017/06B 
  3. Nederlandse Vereniging voor Kindergeneeskunde. Richtlijn 'Gastro-oesofageale reflux(ziekte) bij kinderen van 0-18 jaar' 2012. (www.nvk.nl/Portals/0/richtlijnen/122021%20Def%20RL%20GHOR_testkopie.pdf).
  4. van der Pol RJ, Smits MJ, van Wijk MP, Omari TI, Tabbers MM, Benninga MA. Efficacy of proton-pump inhibitors in children with gastroesophageal reflux disease: a systematic review. Pediatrics. 2011 May;127(5):925-35.
  5. Rosen R, Vandenplas Y, Singendonk M, Cabana M, DiLorenzo C, Gottrand F, et al. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):516-54.
  6. Blokpoel R, Broos N, De Jong-van den Berg L, De Vries T. Waarde omeprazol bij huilende zuigelingen beperkt. Ned Tijdsch Geneeskd. 2010:154:A1850.
  7. Nederlands Huisartsen Genootschap. NHG-Standaard Zwangerschap en kraamperiode. https://www.nhg.org/standaarden/samenvatting/zwangerschap-en-kraamperiode. 2015.
  8. Mitre E, Susi A, Kropp LE, Schwartz DJ, Gorman GH, Nylund CM. Association Between Use of Acid-Suppressive Medications and Antibiotics During Infancy and Allergic Diseases in Early Childhood. JAMA Pediatr. 2018 Jun 4;172(6):e180315.
  9. Dossier 'Off-label voorschrijven'. Via: https://www.knmg.nl/advies-richtlijnen/dossiers/off-label-voorschrijven.htm#.

The literature refers to the Dutch text

Authors

  • dr T.W. de Vries, dr H.J.E.M. Janssens