Aurobindo Named in a Lawsuit for Selling Adulterated Irbesartan Products

Hyderabad-based drug major Aurobindo Pharma Limited has been named in a class action lawsuit in the US for contamination of its irbesartan active ingredient (API) used in the treatment of high blood pressure. The lawsuit was filed in the Federal Court of Florida against Aurobindo Pharma and also the US-based pharma company ScieGen Pharmaceuticals, which used Aurobindo’s irbesartan API to make its blood pressure lowering product, besides the distributor Westminster Pharmaceuticals and the US retail supply chain Walmart. The latest lawsuit is a part of growing litigation against the makers and distributors of sartan-based blood pressure lowering drugs in the US. In July, US Food and Drug Administration (US FDA) initiated a largest-ever Class I recall of valsartan-based blood pressure lowering tablets sold by Solco Healthcare, Major Pharmaceuticals and Teva after it was found that the valsartan active ingredient (API) contained a known carcinogenic impurity called N-nitrosodimethylamine (NDMA), which is expected to show up in sartan-based drugs in certain manufacturing methods. Earlier, the European Medicines Agency announced that it had started reviewing medicines with valsartan ingredient supplied by Chinese company Zhejiang Huahai Pharmaceuticals, which is currently facing similar lawsuits in Missouri, New Jersey, Illinois and New York in the USA.

In October, Aurobindo Pharma announced a voluntary recall of 22 batches of irbesartan due to the detection of trace amounts of NDEA (NNitrosodiethylamine), a human carcinogenic impurity. In August, another Hyderabad-based drug company, Hetero Drugs, announced a recall of around 1.6 million bottles of valsartan tablets from the US market for similar reasons. Recently, US generic drug major Mylan initiated a voluntary recall of valsartan products after the company reported that NDEA was found in some of the APIs made at one of its Indian plants and which Teva also used to make blood pressure lowering products. The lawsuit filed against the irbesartan product manufacturers and distributors said consumers were injured by paying the full purchase price of their medications containing the adulterated irbesartan and by paying for incidental medical expenses and mentioned other grounds. Under American law, a group of people with the same or similar injuries caused by the same product or action can sue the defendant as a group in a class action lawsuit. The class action lawsuits often reach settlements involving payment of compensation by the defendant companies. – Business Standard