Europe probes second impurity in China-made heart drug valsartan before 2012
Frankfurt — Europe’s drugs regulator is looking into another potentially cancer-causing substance in a common blood pressure and heart drug produced in China before 2012, widening an investigation that has so far focused on batches made after 2012. Earlier in 2018, blood pressure drug valsartan, produced by China’s Zhejiang Huahai Pharmaceutical, was found to contain traces of N-nitrosodimethylamine (NDMA), a probable human carcinogen, due to a production change in 2012. The findings have prompted recalls in more than 50 countries. The European Medicines Agency (EMA) said on Thursday that a similar impurity had been detected in products produced before 2012. "In addition to NDMA, EMA is assessing the impact of a related substance, N-nitrosodiethylamine (NDEA), which has been detected in valsartan made by Zhejiang Huahai using its previous manufacturing process before changes were introduced in 2012," it said in a statement. "Data on levels of NDEA are currently very limited, and EMA...
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.
Subscribe now to unlock this article.
Support BusinessLIVE’s award-winning journalism for R129 per month (digital access only).
There’s never been a more important time to support independent journalism in SA. Our subscription packages now offer an ad-free experience for readers.
Cancel anytime.
Questions? Email helpdesk@businesslive.co.za or call 0860 52 52 00. Got a subscription voucher? Redeem it now.