[Omeprazole of limited value in crying babies].
OBJECTIVE
To determine the role of omeprazole treatment in crying infants under the age of 1 year in whom acid gastroesophageal reflux is suspected and to study the evidence for efficacy, prescribing behaviour and side effects of this medicine, which is not registered for use in infants.


METHODS
Literature study.


METHODS
To assess efficacy we conducted a study of the literature using PubMed with the search terms 'gastro-esophageal reflux disease', 'crying', 'adverse drug reactions' and 'omeprazole', in the age category 'all infants 0-23 months' We used the medicine prescription database Interactie DataBase to assess prescribing data and studied reports of suspected side effects of omeprazole in children younger than 1 year to the Lareb Netherlands pharmacovigilance centre.


RESULTS
We found 139 articles including 32 clinical trials. In only 3 of these was the efficacy of omeprazole studied in children under the age of 1 year. These studies showed that there was an effect on the acidity of the stomach, but not on symptoms. Although many side effects may occur during the use of omeprazole, few suspected side effects were reported to the Lareb Netherlands pharmacovigilance centre. Omeprazole is supplied in 10 mg amounts and it is therefore difficult to adjust dose to weight. Pharmacoepidemiological data show therefore that nearly all children receive 10 mg or multiples thereof. Given the age and corresponding weights we expected doses of 4-20 mg/day to be prescribed.


CONCLUSIONS
It is uncertain whether acid reflux is the cause of crying in babies and, if reflux is suspected, whether omeprazole is the preferred treatment.
Blokpoel
Robert G T
RG
Medisch Centrum Leeuwarden, afd. Kindergeneeskunde, Leeuwarden, the Netherlands.
Broos
Nancy
N
de Jong-van den Berg
Lolkje T W
LT
de Vries
Tjalling W
TW
D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight / Q000502:physiology; D003448:Crying; D004305:Dose-Response Relationship, Drug; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D006863:Hydrogen-Ion Concentration / Q000187:drug effects; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D013270:Stomach / Q000502:physiology; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D009853:Omeprazole