FDA Approves Diovan® for Treatment of High Blood Pressure in Children

Diovan® (valsartan), an angiotensin receptor blocker or ARB, has been approved following a priority review by the U.S. Food and Drug Administration (FDA) for the treatment of high blood pressure in children and adolescents ages six to 16.

 High blood pressure has become a multigenerational health issue. Thirty percent of American adults are currently living with high blood pressure and now there are reports that nearly five percent of children and adolescents may have this condition.

Experts suggest that the increase in incidence of high blood pressure among children and adolescents is linked to the growing pediatric obesity epidemic. Based on the National Health and Nutrition Surveys (NHANES), the percentage of overweight children (six to 11 years old) increased from 13.8% to 16.0% between 1999 and 2004, while the share of overweight adolescents (12 to 19 years old) rose from 14.0% to 18.2% during the same period.

No relevant differences were identified between the adverse experience profile for pediatric patients aged six to 16 and that previously reported for adult patients. Diovan is not indicated for treatment in children under six years old.

SOURCE: Novartis Pharmaceuticals Corporation

(1) Sorof J, Lai D, Turner J, et al. Overweight, ethnicity and the prevalence of hypertension in school-aged children. Pediatrics 2004;113:475-482.
(2) Ford ES, et al. Trends in Risk Factors for Cardiovascular Disease Among Children