FDA Drug Information Update about Impurities Found in Certain Generic Angiotensin II Receptor Blocker (ARB) Products

PUBLISHED: Nov 20, 2018
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) today posted Questions and Answers for impurities found in certain generic angiotensin II receptor blocker (ARB) products.

Beginning in late June 2018, the U.S. Food and Drug Administration (FDA) found that some generic versions of the prescription drug valsartan contained unexpected impurities that posed a safety concern. The impurities in these products, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) are probable human carcinogens.

NDMA was the first impurity to be discovered in some valsartan products. During their investigation of valsartan products, the FDA learned of a second impurity, NDEA. Upon testing that now includes other ARBs, NDEA has also been found in some irbesartan and losartan products. All products found to contain these impurities have been recalled and are no longer available in the U.S. market. The FDA’s investigation and testing activities are ongoing.

The new Questions and Answers document addresses thirteen questions and highlights the following important information for healthcare professionals:

  • The FDA has determined the recalled lots of valsartan, irbesartan, and losartan products pose an unnecessary risk to patients
  • The agency recommends that pharmacists provide a replacement product not affected by the recall or prescribers consider other available treatment options for their patient’s medical condition.
  • Lists of valsartan and irbesartan products affected by the recall are available on the FDA website for healthcare professionals and patients to monitor. To date, there is one affected lot of losartan product: Sandoz Inc. losartan potassium hydrochlorothiazide, 100 mg/25 mg tablets, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020. The FDA suggests health care professionals check regularly for updates.
  • Samples can also be affected and part of the recall. Be certain to check samples to ensure affected products are not given to patients.

Follow the link below for additional information.

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