Diovan(R) (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(1).
Experts suggest that the increase in incidence of high blood pressure
among children and adolescents is linked to the growing pediatric obesity
epidemic(2,3). 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(4).
"Novartis believes it is important to provide physicians with treatment
options such as Diovan which are effective in treating high blood pressure
in this vulnerable population of children and adolescents," said John
Orloff, MD, Senior Vice President, Medical and Drug Regulatory Affairs,
Novartis Pharmaceuticals Corporation.
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.
About Diovan
Clinical studies have shown that Diovan effectively lowers blood
pressure. Diovan specifically blocks a hormone that causes arteries to
constrict (tighten and narrow), an action that can cause high blood
pressure.
In adults, Diovan is indicated for the treatment of hypertension when
used alone or in combination with other high blood pressure agents. Diovan
is also indicated for the treatment of heart failure (NYHA class II-IV). In
clinically stable patients with left ventricular failure or left
ventricular dysfunction following myocardial infarction, Diovan is
indicated to reduce cardiovascular mortality.
Taking Diovan during pregnancy can cause injury and even death to an
unborn baby. If you get pregnant, stop taking Diovan and call your doctor
right away. Talk to your doctor about other ways to lower your blood
pressure if you plan to become pregnant.
Do not take Diovan if you are allergic to any of the ingredients in
this product.
Diovan is not recommended for treatment in children with glomerular
filtration rate