The U.S. Food and Drug Administration approved Edarbi tablets (azilsartan medoxomil)
to treat high blood pressure (hypertension) in adults.Data
from clinical studies showed Edarbi to be more effective in lowering 24-hour
blood pressure compared with two other FDA-approved hypertension drugs, Diovan
(valsartan) and Benicar (olmesartan).
“High
blood pressure is often called the 'silent killer' because it usually has no
symptoms until it causes damage to the body,” said Norman Stockbridge, M.D.,
Ph.D., director of the Division of Cardiovascular and Renal Drug Products in
the FDA’s Center for Drug Evaluation and Research. “High blood pressure remains
inadequately controlled in many people diagnosed with the condition, so having
a variety of treatment options is important.”
Edarbi
will be available in 80 milligram and 40 mg doses, with the recommended dose
set at 80 mg once daily. The 40 mg dose will be available for patients who are
treated with high-dose diuretics taken to reduce salt in the body.
Blood
pressure is the force of blood pushing against the walls of the arteries as the
heart pumps. If blood pressure rises and stays high over time, it can damage
the body in many ways. Nearly 1 in 3 adults in the United States has high blood
pressure, which increases the risks of stroke, heart failure, heart attack,
kidney failure, and death.
Edarbi
is an angiotensin II receptor blocker (ARB) that lowers blood pressure by
blocking the action of angiotensin II, a vasopressor hormone.
Adverse
reactions reported by patients taking Edarbi in clinical trials were similar to
those reported by those taking an inactive drug (placebo).
Edarbi
has a boxed warning that says the use of the drug should be avoided in pregnant
women because use of the drug during the second or third trimester can cause
injury and even death in the developing fetus. If a woman becomes pregnant
while using the drug, it should be discontinued as soon as possible.
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