On February 25, 2011 the FDA approved Edarbi tablets (azilsartan medoxomil) for the treatment of hypertension in adults. Data released from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, valsartan and omlesartan. Edarbi will be available in 40 and 80 mg doses. The recommended dose will be set at 80 mg once daily, while the 40 mg dose will be available for patients who are concurrently receiving high-dose diuretics.
Hypertension is often called the “silent killer” as it usually has no symptoms until damage to the body occurs. Blood pressure is the force of blood pushing against the artery walls as the heart pumps. Consistently high blood pressure can damage the body in many ways and has many complications, including stroke, heart failure, heart attack, kidney failure and death. Hypertension remains inadequately controlled in many people diagnosed with the condition, so it is essential to have a variety of treatment options.
Edarbi is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.
A boxed warning included states that the use of the drug should be avoided in pregnant women because use during the second or third trimester can cause injury and even death in the developing fetus. If a woman gets pregnant while using the drug, it should be discontinued as soon as possible.
Adverse reactions reported by patients taking Edarbi in clinical trials were similar to those reported by those on placebo.