Indian generic-drug maker Aurobindo Pharma Ltd.'s U.S. unit Aurobindo Pharma USA Inc. is voluntarily recalling 80 lots of certain high blood pressure drugs due to the detection of cancer-causing impurities.
The drugs being recalled include amlodipine valsartan tablets USP, valsartan HCTZ tablets USP and valsartan tablets USP. Drugs containing valsartan, which was developed by Novartis AG and marketed under the Diovan brand, are used to treat high blood pressure and heart failure.
According to the U.S. Food and Drug Administration's safety report, the drugs were contaminated with trace amounts of a cancer-causing impurity identified as N-nitrosodiethylamine or NDEA.
NDEA occurs naturally in certain foods, drinking water, air pollution, and industrial processes. The International Agency for Research on Cancer has classified NDEA as a probable human carcinogen, a cancer-causing substance.
The U.S. regulator said in a Dec. 31, 2018, report, that Aurobindo Pharma USA has so far "not received any reports of adverse events related to this recall".
In addition, the FDA recommended patients to continue taking the drugs, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients were also advised to contact their pharmacist or physician for an alternative treatment prior to returning their medication.
In July 2018, the European Medicines Agency initiated a review of drugs containing valsartan manufactured and supplied by Chinese drugmaker Zhejiang Huahai Pharmaceutical Co. Ltd.
Zhejiang Huahai came under increased scrutiny by the EU and U.S. regulators after traces of cancer-causing impurities N-nitrosodimethylamine or NDMA and NDEA were found in the company's products and its manufacturing facility was not in compliance with good manufacturing practices.
Due to a rise in the globalization of drug manufacturing, the FDA has been bolstering efforts to temper the entrance of contaminated drugs from foreign sources, a problem that poses risks to public health and global pharmaceutical markets.
Several other drugmakers like Teva Pharmaceutical Industries Ltd., Mylan NV, Major Pharmaceuticals, Inc. and Solco Healthcare have also since made voluntary recalls of certain high blood pressure and heart medicines containing valsartan.
The European Medicines Agency expanded its review to include drugs containing sartan — like candesartan, irbesartan, losartan and olmesartan. In March 2018, the FDA also raised concerns about one of Aurobindo Pharma's sterile formulations plant in India.