After FDA found traces of a compound which is labelled as Human Carcinogen has been found in a drug used to treat High blood pressure and heart disease, the manufacturing company Aurobindo Pharma based USA have voluntarily. The company is recalling 80 lots of Amlodipine Valsartan tablets USP, Valsartan HCTZ, Valsartan USP and USP tablets.
N-nitrosodimethylamine (NDMA) which is a probable human carcinogenic agent have been found actively in the drugs, as reported by USFDA. Although the company based in New Jersey has not received any complaints of adverse effects regarding the drugs as of December 31, the drug which was distributed nationwide has been recalled.
N-nitrosodiethylamine (NDEA) is a product which occurs naturally in contaminated drinking water, air pollution, industrial processes and in certain foods and has been classified as probable human carcinogenic agent by International Agency for Research on Cancer (IARC) classification.
Consumers can identify the products with complete list of details like manufacturer details, product name and batch number as the expiry date ranged from May 2019 to March 2021.
Despite reports, USFDA has urged patients to not completely stop using the prescribed drugs which include Valsartan tablets used mainly by high blood pressure patients, without resorting to alternative treatment drugs. It has also encouraged the patients if their prescription includes the above drugs to contact their doctor to further discus alternate treatment procedures for their condition.
A growing number of companies in 2018 have recalled their drugs for high blood pressure, which has been a cause of concern for many in the health sector and also patients. In November pharmaceutical company, Teva Pharmaceuticals recalled two of the drugs which include the same carcinogenic agent. USFDA is committed to investigating all angiotensin II receptor blockers (ARBs) which have shown traces of NDEA and NDMA.
Another class of potassium drugs have been recalled recently which was used to treat hypertension. Losartan Potassium tablets USP which were used to treat hypertensive patients with left ventricular hypertrophy as well as nephropathy in type 2 diabetic patients was created by Torrent Pharmaceuticals. The recall expanded from 2 lots to 10 lots. The recent drug recalls have disturbed and spread confusion in the health sector as other good alternative drugs which does not include NDEA or NDMA are not available in the market.