FDA/CDC

FDA names 40 ARBs that are free of nitrosamines


 

The Food and Drug Administration has identified 40 angiotensin II receptor blockers (ARBs) that do not contain the environmental contaminants, nitrosamines.

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This marks the first time the FDA has released a list of nitrosamine-free ARBs since impurities in these antihypertensive drugs were discovered last summer, according to a statement from the regulatory agency.

Among the drugs on this list are Accord Healthcare’s amlodipine and olmesartan medoxomil, Alembic Pharmaceuticals’ valsartan and hydrochlorothiazide, and Hisun Pharmaceuticals USA’s telmisartan.

Despite the FDA’s findings, the agency recommends patients continue taking the ARBs they have been prescribed until their pharmacists or physicians change their prescriptions to a safe replacement or different treatment option.

“We want to reassure patients that we strongly believe the risks, such as stroke, of abruptly discontinuing these important medications far outweighs the low risk associated with continuing the medications with these impurities,” says the statement.

The FDA noted that it is “continuing to work with manufacturers to swiftly remove medications from the market if they contain a nitrosamine impurity at levels higher than the interim acceptable intake limits,” and that this effort has resulted in shortages of valsartan products. In anticipation of more shortages, the FDA “is not objecting to temporary distribution” of specific lots of losartan containing impurities at levels exceeding the regulatory agency’s aforementioned standards.

The FDA’s scientists said that using ARBs with impurity levels above the interim acceptable intake limits over the time it should take to get impurity-free losartan to market will not result in an increased risk for cancer.

More information, including the full statement, is available on the FDA’s website.

cpalmer@mdedge.com

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