Titre : Toxin at heart of drug recall shows holes in medical safety net
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Toxin at heart of drug recall shows holes in medical safety net
August 22, 2018Toxin at heart of drug recall shows holes in medical safety net
Alexandra Harney, Ben Hirschler
SHANGHAI/LONDON (Reuters) - A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.
China’s Zhejiang Huahai Pharmaceutical (600521.SS), which produces bulk ingredients for drugmakers, told its customers in late June it had found NDMA in its valsartan, an off-patent blood pressure drug originally developed by Novartis (NOVN.S). The discovery means that some of the 10 billion pills containing valsartan sold worldwide last year to prevent heart attacks and strokes had traces of N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen. No one has been reported as sickened by the toxin, once used in the production of liquid rocket fuel...
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