Not ready for prime time: aliskiren for treatment of hypertension or proteinuria in children
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Joseph T. Flynn
- چاپ و سال / کشور: 2011
Description
Sirs, In the past, children were often excluded from studies of new medications, resulting in insufficient efficacy and safety data [1]. While this situation has been rectified to a large extent by legislative initiatives in the United States and Europe, there may still be a delay between approval of a new drug for use in adults and completion of clinical trials in the pediatric age group, resulting in the practice of “off-label” prescribing in children until pediatric data are available. Off-label prescribing, while allowable, is undesirable as patients may be exposed to unknown risks of the unstudied medication. Children with chronic or serious diseases are commonly exposed to off-label medication use, and such off-label use has been shown to be accompanied by a high rate of adverse drug reactions [2, 3].
Pediatr Nephrol (2011) 26:491–492 DOI 10.1007/s00467-010-1726-4 Received: 2 November 2010 / Revised: 7 November 2010 / Accepted: 10 November 2010 / Published online: 15 December 2010
