The US Food and Drug Administration warns of a shortage of medicines used by millions of people to treat high blood pressure. The drugs known as ARBs or angiotensin II receptor blockers contain valsartan.
"Valsartan products are shortages, and we know that other types of products may soon be in short supply," FDA Commissioner Dr. Scott Gottlieb and FDA director Janet Woodcock said in a statement released Friday.
The alert is being recalled from the market as a growing list of medicines containing valsartan, losartan and irbesartan because they contain an impurity that is a cancer risk.
This contamination was discovered in July when FDA lab tests found that some medications that contained valsartan were contaminated with a chemical called NDMA, an environmental pollutant and possibly a carcinogen. The manufacturing process might have "resulted from the reuse of materials such as solvents "can result.
The FDA is testing all ARBs for these impurities. He had to design a special test after learning that some ingredients imported from a Chinese company, Zhejiang Huahai Pharmaceuticals, were contaminated.
The FDA had alerted Zhejiang Huahai Pharmaceuticals to an import alert at the end of September, which means all active pharmaceuticals. Products and finished products of the company are not allowed to enter the US. The FDA made this decision after inspecting the device, revealing "systemic monitoring issues that may have created the conditions for quality issues".
The FDA said the total burden of the stained drugs "appears to be low overall" The agency's concern about the nature of the contamination was not mitigated. The aim, the agency said, "is to reduce the risk of patients receiving low levels of contamination (below acceptable levels) for a short period of time, with the risk that certain ARBs may be missing, which may affect patients "The ability to access the drugs they need".
So far, the long-term risks that NDMA is taking with certain valsartan-containing drugs are not yet known, and the amount of NDMA consumed would play a role in these risks. Erin Michos, Associate Professor and Associate Director of Preventive Cardiology Johns Hopkins Medicine, CNN said in November.
In other words, "The dose makes the poison," she said. "What we know about the dangers of this pollution comes primarily from laboratory studies. It is a toxin that can affect the liver and cause liver fibrosis or scarring and liver tumors in rats. It is thought to be toxic to humans as well, "said Michos.
" In these animal studies, they usually deliver large quantities, so the risk in humans is unlikely to be the same equivalent, "she said.