Table 1—

Current unlicensed and off-label use of gastrointestinal drugs

Drug typeSpecific drugLicensing arrangements
PERT Pancreatin, for example
Creon 10,000TM (Solvay, Southampton, UK)Pancreatic insufficiency in children of all ages
Creon MicroTM (Solvay, Southampton, UK)Pancreatic insufficiency in children of all ages
Nutrizym 10TM (Merck Serono, Feltham, UK)Children aged over 2 yrs
PancrexTM (Paines and Byrne, Staines, UK)Children aged over 2 yrs (capsules in infants)
High-strength preparationsNot licensed for children under 15 yrs with CF
Oral calorie supplements Different licensing arrangements (ACBS)Children aged over 3 yrs
Drugs to reduce gastric acid OmeprazoleCapsules and tablets not licensed in children except for severe ulcerating reflux oesophagitis (injection not licensed in children aged under 12 yrs)
LansoprazoleNot licensed for children
RanitidineOral not licensed in children aged under 3 yrs (injections not licensed in children aged under 6 months)
CimetidineNot licensed in children aged under 1 yr
Treatment for DIOS GastrografinLicensed for uncomplicated meconium ileus (not specifically licensed for DIOS, but is licensed for “infants and young children”)
N-AcetylcysteineNot licensed for use in children with CF
Sodium bicarbonate Not licensed
Laxatives LactuloseLicensed for children
BisacodylNot licensed for children aged under 10 yrs
DocusateNot licensed for children aged under 12 yrs
MovicolTM (Norgine, Harefield, UK)Licensed for children aged 2 yrs and older
Fat soluble vitamins Vitamin E suspensionLicensed for children with CF (all age groups)
Multivitamin dropsLicensed for children of all ages
Motility agents DomperidoneNot licensed for children
Taurine Not licensed for children
  • PERT: pancreatic enzyme replacement therapy; DIOS: distal ileal obstruction syndrome; CF: cystic fibrosis; ACBS: Advisory Committee on Borderline Substances.