Drug related problems and off-label drug treatment in children as seen at a drug information centre

Off-Label Drug Information

drug into interstate commerce unless the FDA has approved the drug and its label.2 A second provision prohibits manufacturers from introducing misbrandeddrugs into interstate commerce.2 Misbranding is considered to occur if drug labeling contains information that describes unapproved uses or is misleading or insufficient to support safe use for approved indications.2 Materials are considered pa...

Poly Drug Use - A Challenge for Drug Treatment

Poly-drug use refers to the use of two or more substances at the one time or repeatedly. It is common among both recreational and regular drug users across the world. Poly-drug use is a great contributor to the global number of deaths related to drug overdose. In this case, the likelihood of drug overdose and its pertaining complications in an individual is higher especially when benzodiazepine...

Off-label drug use in pediatric patients.

INTRODUCTION Until recently, it was considered unethical or impossible to perform clinical trials of new medicines in children. As a consequence, many medicines used for treating children are insufficiently documented with regard to dosing, efficacy, and safety. The off-label use of drugs has been extensive in treating the pediatric population. This article gives an overview of the extent and t...

Prohibition against off-label drug promotion challenged.

Off-label drug use: author's reply.

The authors have stated that the accuracy of dose was checked from standard neonatal formularies, viz. British National Formulary 2005 and Neofax 2008, and stated that 75% of medications were not approved by FDA for neonatal use. They have not mentioned the document or the source that they relied upon to classify the drug as off-label or otherwise. It may not be advisable to decide if use of a ...