Off-Label Drug Use in Pediatric Practice: Unsolved Problems
نویسندگان
چکیده
منابع مشابه
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...
متن کامل[Off-label prescription: practice and problems].
Approval of a drug for clinical use requires production of data on efficacy and safety through submission of results from randomized controlled trials (RCTs), in which the new molecule is usually compared with placebo (or an active comparator) for a set of outcomes that will serve as the basis for the drug's indications. These indications are crucial, because drugs are approved on the basis of ...
متن کاملOff-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 ...
متن کاملAutomated Detection of Off-Label Drug Use
Off-label drug use, defined as use of a drug in a manner that deviates from its approved use defined by the drug's FDA label, is problematic because such uses have not been evaluated for safety and efficacy. Studies estimate that 21% of prescriptions are off-label, and only 27% of those have evidence of safety and efficacy. We describe a data-mining approach for systematically identifying off-l...
متن کاملOff-label use of drug-eluting stents.
ince Food and Drug Administration (FDA) approval of he first drug-eluting stent (DES) in April 2003, their use ncreased to 90% of all coronary stent procedures in the U.S. y 2006 (1). With restenosis virtually eliminated, DES were pplied to increasingly more complex coronary lesions. owever, over the past few years, reports of late stent hrombosis began to emerge. Additional reports of late ste...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Pediatric pharmacology
سال: 2015
ISSN: 1727-5776
DOI: 10.15690/pf.v12i3.1355