"We carefully reviewed the valsartan-containing drugs sold in the US and found that the valsartan sold by these specific companies did not meet our safety standards, so we urged these companies to take immediate action to protect patients," said Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research.
NDMA is an organic chemical that is in a family of powerful carcinogens. It has been used, inter alia, for the production of liquid rocket fuel, plasticizers and lubricants. It can also be produced unintentionally by certain chemical reactions and is a by-product in the manufacture of pesticides, the production of rubber tires or fish processing.
Novartis spokesman Eric Althoff said after the first recall last week that the products sold in the US were not affected by this recall, the FDA's ongoing review and laboratory testing revealed a different outcome. "The presence of NDMA was unexpected and is believed to be related to changes in the way the drug was manufactured," the FDA press release states.
"The levels of NDMA found in the Valsartan API are much lower than the cumulative endogenous production and usual external exposure of NDMA," Althoff wrote in an e-mail on July 6. "There is no certainty about how much this contamination could potentially increase cancer risk. Therefore, the amount of NDMA found in the Valsartan API would not pose a significantly increased risk to patients taking Sandoz Valsartan and Sandoz Valsartan HCT film-coated tablets "
The FDA continues to investigate the drug.
"The FDA is committed to maintaining our gold standard for safety and efficacy, including our efforts to ensure the quality of medicines and safe manufacturing," said EU Commissioner. Scott Gottlieb on Friday. "If we find that there are quality defects in the drugs and manufacturing issues that can potentially cause risks to patients, we are determined to take immediate action to raise public awareness and facilitate product removal from the market Drugs are also working hard to ensure that the therapeutic needs of patients in the United States are met with adequate supplies of unaffected drugs. "