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EU investigating second impurity in China-made heart drug

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FRANKFURT (Reuters) – 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.

Blood pressure drug valsartan, produced by China’s Zhejiang Huahai Pharmaceutical, was this year 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 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 will provide further information on whether its presence impacts the risk assessment once more information becomes available.”

The watchdog also said further risk assessment had confirmed that the life-time risk of cancer from exposure to levels of NDMA detected in valsartan was considered low.

Officials at Zhejiang Huahai could not be reached for comment outside regular business hours in China.

(Reporting by Ludwig Burger; Editing by Thomas Seythal and Mark Potter)

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