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Regulators flag other potential carcinogens in China-made heart drug



The European and North American regulatory authorities have said that they are investigating a second potentially carcinogenic substance in a commonly used blood pressure drug manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals.

Healthcare Agency statements in the EU, US and US Canada adds concerns that were flagged earlier this year when the drug, valsartan, was found to contain traces of N-nitrosodimethylamine (NDMA), a likely human carcinogen, due to a change in production in 2012.

The results have already led to recalls in more than 50 countries, affecting several Chinese and Indian companies.

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On Thursday, the European Medicines Agency (EMA) said a similar contamination had been detected in products produced before 2012.

"In addition to NDMA evaluating EMA effects of a related substance, N-nitrosodiethylamine (NDEA), detected in valsartan made by Z Hejiang Huahai uses its previous manufacturing process before changes were introduced in 2012, "said a statement.

"NDEA levels are currently very limited, and EMA will provide further information about whether its presence affects risk assessment once more information becomes available."

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

A representative of Torrent Pharmaceuticals refused to comment.


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