FDA Issues Alert on Irbesartan Due to Contamination

Megan Brooks


November 01, 2018

SciGen Pharmaceuticals has voluntary recalled certain lots of the angiotensin II receptor blocker (ARB) irbesartan, owing to the presence of N-nitrosodiethylamine (NDEA), a probable human carcinogen, the US Food and Drug Administration (FDA) said in a drug safety alert.

Laboratory testing confirmed the presence of NDEA in some lots of ScieGen's irbesartan. "This is the first non-valsartan drug product the agency has found to contain the NDEA impurity," the FDA said.

ScieGen's recall affects about 1% of the irbesartan drug products in the US market.

To date, SciGen said it had not receive any reports of adverse events related to this recall, the company said in a statement.

The recalled irbesartan tablets (USP 75, 150, and 300 mg) were manufactured by SciGen and are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS). A list of irbesartan products under recall is available online.

Additionally, the FDA announced that Aurobindo Pharma Ltd, which manufactures the active pharmaceutical ingredient (API) for ScieGen's irbesartan products, has recalled all unexpired lots of its irbesartan API supplied to the US market with NDEA. "FDA and Aurobindo laboratory testing confirmed NDEA in certain lots of their irbesartan API," the FDA said.

The saga of contaminated "sartans" began in July, when some valsartan products manufactured by China's Zhejiang Huahai Pharmaceuticals (ZHP) were found to be contaminated with another potential carcinogen, N-nitrosodimethylamine (NDMA). This led US and European regulators to pull all affected valsartan products from the market.

In September, the FDA banned imports of API and finished drug products produced by ZHP, as reported by Medscape Medical News.

The FDA said it is continuing to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities. "The combined headspace method and the combined direct injection method can detect and quantify NDMA and NDEA simultaneously in ARB API and finished drug products," the agency said.

Adverse reactions or quality problems associated with the use of these products should be reported to the FDA's MedWatch Adverse Event Reporting Program.

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