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Volume 19 - Issue 3, May-June 2017
ORIGINAL
COMPARATIVE APPROVED THERAPEUTIC INDICATIONS IN PEDIATRICS FOR PROTON PUMP INHIBITORS AND H2-RECEPTOR ANTAGONISTS IN ITALY AND USA
FEDELE DANIELA, PELLI GIULIA, DELFINO MARCELLO, MOTOLA DOMENICO, MARRA ANNA


Objectives: several published studies highlight the wide use of proton pump inhibitors and anti-H2 drugs in children. The off-label use in pediatric patient is due, in most cases, to the lack of adequate clinical trials in this age group due to ethical, methodological and economic reasons. The aim of our analysis was to evaluate the
comparative scenario between Italy and USA in terms of therapeutic indications and dosage already authorized in corresponding Summary of Product Characteristics (SPC) for PPI and H2-receptor antagonists in children and to discuss possible differences.

Method: we performed an analysis in order to evaluate the comparative scenario between Italy and USA in terms of therapeutic indications and dosage already authorized in corresponding Summary of Product Characteristics for proton pump inhibitors and H2-receptor antagonists in children and to discuss possible differences.

Results: we observed that in USA but not in Italy all drugs belonging to such classes are already indicated for use in pediatrics.

Conclusions: the therapeutic indications already authorized in other countries and the consolidated clinical practice for certain drugs could represent available evidence enough to extend the indications for children in other countries by reducing regulatory obstacles and avoiding duplication of unethical clinical trials in this age group. Prescription of all the drugs in children, even more for off-label ones, should be made only when the expected benefits outweigh the possible risk in order to ensure the appropriate use of drugs in this sensitive population.

H2-RECEPTOR ANTAGONISTS – OFF-LABEL USE – PEDIATRICS – PROTON PUMP INHIBITORS – SUMMARY OF PRODUCT CHARACTERISTICS



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