Edarbi Should Not Be Used to Lower Blood Pressure, Group Warns

The prominent consumer advocacy group Public Citizen is warning that the blood pressure medication Edarbi should not be used, as there is no evidence of cardiovascular health benefits with the medication and people may be better off exercising and limiting their use of salt. 

In the July issue of Public Citizen’s Worst Pills, Best Pills newsletter, the group designated Edarbi (azilsartan) as a “Do Not Use” medication for treatment of high blood pressure. In addition to the lack of any heart benefits, Public Citizen indicates that there are potential health risks when Edarbi is used in combination with certain other drugs.

Edarbi is an oral medication introduced by Takeda Pharmaceuticals in February 2011, designed to lower the blood pressure of patients within 24 hours. It is an angiotensin II receptor blocker (ARB), which lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.

According to an FDA press release issued when the medication was approved, the regulatory agency determined that Edarbi was more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan).

However, Public Citizen reports that unlike Edarbi, Teveten, Avapro and Benicar, several approved ARBs have been shown, in specific groups of patients, to reduce the risk of serious cardiovascular outcomes that can result from high blood pressure. Public Citizen reviewed a study published in the Canadian Medical Association Journal that found that people prescribed an angiotensin converting enzyme (ACE) inhibitor in combination with an angiotensin receptor blocker (ARB) had greater risks of kidney toxicity and higher levels of potassium in the blood compared to people using a drug from either of the two families alone.

They also cited a safety alert issued by the FDA in April 2012, which warned patients not to take any ARB or ACE inhibitor with aliskiren. Concomitant use of aliskiren with ARBs or ACEIs in patients with diabetes is contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia, the alert indicated.

Edarbi contains a black box warning, which is the strongest warning that can be placed on a prescription medication, indicating that use of the drug should be avoided in pregnant women during the second or third trimester due to the risk of fetal injury or death. If a woman becomes pregnant while using the drug, she should discontinue its use as soon as possible.