The FDA has 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
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
Adverse reactions reported by patients taking Edarbi in
clinical trials were similar to those reported by those taking an inactive drug
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.
Edarbi is made by Takeda Pharmaceutical North America of Deerfield,