The Food and Drug Administration officials said Friday that some versions of the blood pressure-lowering drug valsartan contained trace amounts of a carcinogen for four years before regulators detected the impurity last summer, triggering a widespread recall of the tainted drugs. FDA officials said the cancer risk for any person who took valsartan that had the carcinogen nitrosodimethylamine, or NDMA, is small. <...> The FDA's investigation concluded the contaminants likely resulted from a manufacturing change adopted by factories in China and India that make the drug ingredients. The manufacturing change may generate the contaminants "when specific chemicals and reaction conditions are present" and can result of reusing materials such as solvents. The FDA said that NDMA is difficult to detect in standard lab testing, but the federal agency has refined testing methods and shared that information with pharmaceutical companies. Factories at risk for generating the contaminants must test both pharmaceutical ingredients and finished drugs to verify they are free of detectable impurities, the FDA said. https://www.usatoday.com/story/news/health/2019/01/25/fda-investigates-cause-carcinogens-blood-pressure-drugs/2678934002/
Понятно, что инспекторам FDA нужно придумывать себе работу.
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Date: 2020-03-14 08:06 pm (UTC)The Food and Drug Administration officials said Friday that some versions of the blood pressure-lowering drug valsartan contained trace amounts of a carcinogen for four years before regulators detected the impurity last summer, triggering a widespread recall of the tainted drugs.
FDA officials said the cancer risk for any person who took valsartan that had the carcinogen nitrosodimethylamine, or NDMA, is small. <...>
The FDA's investigation concluded the contaminants likely resulted from a manufacturing change adopted by factories in China and India that make the drug ingredients. The manufacturing change may generate the contaminants "when specific chemicals and reaction conditions are present" and can result of reusing materials such as solvents.
The FDA said that NDMA is difficult to detect in standard lab testing, but the federal agency has refined testing methods and shared that information with pharmaceutical companies.
Factories at risk for generating the contaminants must test both pharmaceutical ingredients and finished drugs to verify they are free of detectable impurities, the FDA said.
https://www.usatoday.com/story/news/health/2019/01/25/fda-investigates-cause-carcinogens-blood-pressure-drugs/2678934002/
Понятно, что инспекторам FDA нужно придумывать себе работу.