Aurobindo Pharma USA Inc., an American unit of the India-based generic pharmaceuticals manufacturer, Aurobindo Pharma Ltd., is currently in the news for recalling around 80 lots of medicines used for treating heart failure and high blood pressure, from the U.S. market. The surprising move by the drug-maker apparently comes along the heels of the discovery of cancer-causing impurities present in the drug.
Reportedly, the U.S. FDA (Food & Drug Administration) claimed that the impurity, scientifically known as NDEA (N-Nitrosodiethylamine), was found in unconventional amounts in certain tablets including Valsartan HCTZ tablets USP, Amlodipine Valsartan tablets USP, and Valsartan tablets USP, which resulted in the voluntary recall of the medicine.
As per a report by Reuters, the latest announcement of the BP drug recall has been made a month after Mylan N.V., a US-based global pharmaceutical company, had affirmed that it would recall all lots of the Valsartan drug containing an Angiotensin II receptor blocker post the drug’s ban by global health authorities. Currently, the U.S. FDA is planning to continue investigation as well as test the receptor blockers in the drug for NDEA presence and another probable carcinogen N-nitrosodimethylamine.
Aurobindo Pharma recently stated that according to an IARC (International Agency for Research on Cancer) classification, the impurity NDEA discovered in the finished drug is a naturally-occurring substance found in drinking water, industrial processes, air pollution, and certain foods. It has been broadly classified as a possible human carcinogen, cited authentic sources.
According to reliable reports, NDEA is a synthetic oil that is used as a stabilizer and antioxidant in plastics and also as a lubricant additive. It oil is said to affect the DNA integrity and is used in liver tumorigenesis research. Sources added that it is reasonably considered as a human carcinogen.
It has been reported that the company is informing its customers and distributors of the latest flaw in the drug and is requesting them to discontinue distribution of the recalled lots.