Advocacy for pediatric research
From Pahwiki
Contents |
[edit] The Need for Pediatric Research
Like most diseases, pulmonary hypertension pediatric research lags far behind that of adult research. Greater awareness of the deficiencies of pediatric research are necessary to eliminate this gap.
[Children with Pulmonary Hypertension] addresses the need for greater pediatric emphasis and awareness.
[edit] Pediatrics and FDA approved dosing
[edit] Revatio
Safety and effectiveness in pediatric pulmonary hypertension patients have not been established.
[edit] Flolan
Safety and effectiveness in pediatric patients have not been established.
[edit] Coumadin
Safety and effectiveness in pediatric patients below the age of 18 have not been established, in randomized, controlled clinical trials. However, the use of COUMADIN in pediatric patients is well-documented for the prevention and treatment of thromboembolic events. Difficulty achieving and maintaining therapeutic PT/INR ranges in the pediatric patient has been reported. More frequent PT/INR determinations are recommended because of possible changing warfarin requirements.
[edit] Tracleer (Bosentan)
Safety and efficacy in pediatric patients have not been established.
[edit] Procardia (Nifedipine)
Safety and effectiveness in pediatric patients have not been established.
[edit] Remodulin
Safety and effectiveness in pediatric patients have not been established. Clinical studies of Remodulin did not include sufficient numbers of patients aged <16 years to determine whether they respond differently from older patients. In general, dose selection should be cautious.
[edit] Ventavis (Iloprost)
Safety and efficacy in pediatric patients have not been established.
[edit] Lipitor
For pediatric patients (10-17 years of age) with heterozygous familial hypercholesterolemia, the recommended starting dose of LIPITOR is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines1, CLINICAL PHARMACOLOGY, and INDICATIONS AND USAGE). Adjustments should be made at intervals of 4 weeks or more.
[edit] Letairis (Ambrisentan)
Safety and effectiveness in pediatric patients have not been established.
