Healthy Skepticism Library item: 9680

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

Choonara I.
Unlicensed and off-label drug use in children: implications for safety.
Expert Opin Drug Saf 2004 Mar; 3:(2):81-3

Abstract:

Throughout the world, many drugs prescribed for children are used in an off-label or unlicensed manner. The incidence of unlicensed and off-label drug prescriptions appears to be greatest in critically ill neonates and children and lowest in the general population. The risk associated with unlicensed and off-label drug use appears to be greater than for prescribing in accordance with the product licence. Health professionals, however, usually have no alternative but to use unlicensed and off-label medicines. More clinical trials for medicines in children are required to provide the evidence base for safe and effective drug prescribing.

Keywords:
Child Drug Approval/legislation & jurisprudence* Drug Labeling*/classification Drug Labeling*/legislation & jurisprudence Drug Therapy/adverse effects* Drug Therapy/utilization Drug Utilization Humans Physician's Practice Patterns*