Aurobindo faces US suit over carcinogenic elements in blood pressure drug

Hyderabad-based drug major Aurobindo Pharma has been named in a class action lawsuit in the US for alleged contamination of its irbesartan active ingredient (API) used in treatment of high blood pressure.

The lawsuit was filed in the Federal Court of Florida against Aurobido Pharma and also US-based pharmaceutical company Sciegen Pharmaceuticals, which used Aurobindo’s irbesartan API to make its own blood pressure lowering product. Distributor Westminster Pharmaceuticals and the US retail supply chain Walmart were also named in the lawsuit.  

Aurobindo scrip lost as much as Rs 22 (down close to 3 per cent) on Tuesday after touching a new 52-week high of Rs 830 on Monday.

The latest lawsuit is part of a growing litigation against makers and distributors of sartan-based blood pressure lowering drugs in the US. In July, US Food and Drug Administration (USFDA) initiated the largest-ever Class I recall of valsartan-based tablets for the purpose sold by Solco Healthcare, Major Pharmaceuticals and Teva Pharmaceutical Industries 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 October, Aurobindo Pharma announced a voluntary recall of 22 batches of irbesartan because of the detection of trace amounts of NDEA (NNitrosodiethylamine), a human carcinogenic impurity.  In August, another Hyderabad-based drug company, Hetero Drugs, announced recall of around 1.6 million bottles of valsartan tablets from the US market for similar reasons.

Recently, US generic drug major Mylan initiated 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. The same was reportedly was by Teva to make its blood pressure lowering products. 

The lawsuit filed stated that consumers were injured by paying the full purchase price of their medications containing the adulterated irbesartan and for paying for incidental medical expenses. Under the 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 lawsuit often reach settlements involving payment of compensation by the defendant companies.


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