This impurity was discovered in July when FDA lab tests detected this. Some medications containing valsartan were contaminated with a chemical called NDMA, an environmental pollutant and possibly a carcinogen.
The FDA said that its ongoing investigations have revealed that impurities have been created in the manufacturing process and may be due to the reuse of materials, such as solvents. "
The FDA is testing all ARBs for these contaminants and had to design a special test after learning that some ingredients imported from a Chinese company, Zhejiang Huahai Pharmaceuticals, were contaminated.
The FDA has alerted Zhejiang Huahai Pharmaceuticals to an import alert in late September The FDA made this decision after inspecting the facility and exposing "systemic problems of oversight that could have created the conditions for the occurrence of quality issues."
The FDA said the total burden of the contaminated Drugs are "small" The concern of the agency over the nature of the contamination was dad not diminished. The aim, said the Agency, "is to balance the risk of patients receiving small amounts of contaminants (below acceptable levels) for a short time with the risk of a shortage of certain ARBs that may affect patients." Ability to access the drug they need. "
So far, the long-term risks that NDMA undergoes with certain valsartan-containing medications are somewhat unknown, and the amount of NDMA consumed would play a role in these risks Erin Michos, Associate Professor and Associate Director of Preventive Cardiology at Johns Hopkins Medicine, told CNN in November.
In other words, "The dose makes the poison," she said. "What we know about the dangers of this contamination stems mainly from laboratory studies. It is a toxin that can affect the liver and cause liver fibrosis or scarring, as well as liver tumors in rats. It is believed to be toxic to humans as well. "Michos said.
" In these animal studies, they usually deliver large amounts, so the risk in humans is unlikely to be the same equivalent, "she said.