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Aurobindo recalls hypertension drug in US, cites cancer risk

NDEA is used in the making of liquid rocket fuel and is a byproduct of fish processing as well as manufacturing of certain pesticides.

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Hyderabad-headquartered Aurobindo Pharma Ltd has initiated a voluntary recall of 22 batches of Irbesartan, used for treating blood pressure, in the United States due to the presence of an impurity that could cause cancer.

In a recent notification on its website, the US Food and Drug Administration (FDA) said that the recall of drug substance Irbesartan was due to the presence of an impurity, N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes. NDEA has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

NDEA is used in the making of liquid rocket fuel and is a byproduct of fish processing as well as manufacturing of certain pesticides.

These 22 batches of Irbesartan drug substance were supplied to ScieGen Pharmaceuticals Inc, US for the manufacturing of finished Irbesartan drug product, the notification further said.

According to the US FDA website, Aurobindo Pharma has notified ScieGen Pharmaceuticals of the recall and is arranging for the return of all available Irbesartan drug substance. The pharmaceutical manufacturer has further advised Sciegen Pharmaceuticals to contact its distributors and retailers to return Irbesartan drug product and finished Irbesartan tablets that have been identified by the drug manufacturer.

The US drug regulator has advised patients on Irbesartan medication to continue taking it as the risk to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment. 
Patients should contact their pharmacist or physician about alternative treatment prior to returning the medication, the notification added.

Of the 22 batches being recalled, two were manufactured in January 2016, four in September 2017, eight in October 2017 and eight in November 2017. Except for one batch where the presence of NDEA impurity has been found as 1.61 microgram/gram, the level of the impurity is below 1 microgram/gram in the remaining 21 batches.

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