Trends in utilization and off-label use of polyethylene glycol 4000 laxatives and the prevalence of constipation in children in France

PURPOSE To determine trends in utilization and off-label use of polyethylene glycol (PEG) 4000 in children and to determine the prevalence of constipation. METHODS Retrospective cross-sectional analyses were conducted from 1997 to 2007 in a French health care database comprising general practitioners and pediatricians. Patients prescribed PEG 4000 (Forlax(®); Ipsen Pharma, Paris, France) were used to assess PEG 4000 use; constipation was defined by a diagnosis of constipation or use of any laxative. Analyses used linear regression models to fit trends over time. RESULTS The study sample consisted of a nationally representative sample of 1200 general practitioners with 1.6 million patient medical records and 100 pediatricians with 70,000 patient medical records. Data were available from 1997 to 2007 for general practitioners and from 2003 to 2007 for pediatricians and were extrapolated to the national level. Among both groups of physicians there were statistically significant increases in the number of patients prescribed 4 g. For the 10 g dose, there was a decline among pediatricians. The largest increases were in children aged 0-8 years and in females. The prevalence of constipation in children aged 0-18 years was 4%. CONCLUSION There has been an increase in the use of PEG 4000 laxative in children, particularly in the younger ages and in females. Use of the 4 g dose has increased. There was considerable off-label use of PEG 4000 in children aged 0-8 years before the introduction of the 4 g pediatric dose, which reflected clinical need.