Valsartan gets into more trouble after the link has been found with the 4th potential carcinogen &the popular blood pressure medication valsartan. United States Food and Drug Administration has been informed that a solvent known as dimethylformamide (DMF) was discovered in valsartan made by numerous firms, inclusive of Novartis. Dimethylformamide is classified by the World Health Organization as a potential carcinogen.
These findings would make the efforts of the agency harder to pull the contaminated products from the pharmacies while meanwhile informing the patients and doctors which products are safe for the usage.
Recalls for valsartan, as well as, irbesartan, losartan, and mixture medications have been ongoing since Food and Drug Administration initiated an investigation into the foreign manufacturing process for active pharmaceutical ingredients in these drugs, causing impurities in the form of N-nitrosodiethylamine & N-nitrosodimethylamine, which are alleged human carcinogens.
Investigation of the Food and Drug Administration began back in June 2018, when the agency was informed that Prinston Pharmaceuticals had halted manufacturing valsartan products since it had detected traces of N-nitrosodimethylamine in valsartan API supplied by the Chinese manufacturer Zhejiang Huahai Pharmaceutical Co. Food and Drug Administration put ZHP on import alert, blocking all API from legally entering the US. There was an identification of another supplier of tainted valsartan API in India.
At the beginning of March, the presence of a 3rd carcinogen, N-nitroso-N-methyl-4-aminobutyric acid, was found in the majority of losartan potassium (25 milligrams, 50 milligrams, and 100 milligrams) manufactures by Hetero Labs in India & distributed by Camber Pharmaceuticals.
The alleged presence of now a 4th carcinogen seems to have prompted lawmakers of the United States to dig out more information on Food and Drug Administration’s capability to protect the nation’s prescription drug supply.