Healthy Skepticism Library item: 7750

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Schobben AF, Rademaker CM.
Awakening attention for a particular target group. Drug registrations for children
Pharmaceutisch Weekblad 2002; 137:(18):651-654

Abstract:

A significant part of drugs prescribed for children are off label or not registered. This possibility is allowed but it is not without risk. Despite requirements and guidance by registration authorities the pharmaceutical industry is restrictive in initiating trials in children. Therefore dosing guidelines and suitable formulations are often missing. The scattered information of small trials, case reports and personal experiences has been collected in some pediatric formularies. There is high need to expand the possibilities of sage and effective drug treatment for children. Even after registration for children the experience with a drug in different age groups is very limited. Post-marketing surveillance is of utmost importance both for old and new therapies in children. Several initiatives to share experience on formulating and application form deserve full cooperation.