Approval of Diovan (valsartan) in U.S. for hypertension in children and adolescents

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(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 <30 mL/min/1.73 m(2).

The most serious side effects with Diovan are low blood pressure (hypotension) and kidney problems. Other side effects with Diovan have generally been mild. In hypertensive patients, the most common side effects with Diovan are headache and dizziness.

The most common side effects of Diovan when used to treat people after a heart attack which cause them to stop taking the drug include low blood pressure, cough, rash and high blood creatinine (decreased kidney function). When used to treat people with heart failure, the most common side effects include dizziness, low blood pressure and diarrhea.

Diovan is a prescription medication.