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Regulators flag second potential carcinogen in China-made heart drug



European and North American regulators said they are examining a second potentially carcinogenic substance in a blood pressure medicine commonly used by the Chinese firm Zhejiang Huahai Pharmaceuticals.

Statements by health regulators in the EU, US and Canada are in addition to the concerns reported at the start of this year when the drug, valsartan, was found to contain traces of N -nitrosodimethylamine (NDMA), a probable human carcinogen, due to a change in production in 2012.

The results have already induced recalls in more than 50 countries, affecting several Chinese and Indian companies [19659006] 3 BREAST CANCER DIES AFTER THE RECOVERY OF THE ORGANS FROM THE SAME DONOR: REPORT

Thursday the European Medicines Agency (EMA) stated that a similar impurity had been detected in products produced before 2012.

"In addition to NDMA, EMA is evaluating the impact of a related substance, N-nitrosodiethylamine (NDEA), which was detected in valsartan by Z hejiang Huahai uses his previous manufacturing process before that the changes were introduced in 2012, "reads a note.

"Data on NDEA levels are currently very limited and EMA will provide further information on whether its presence influences the risk assessment once further information becomes available."

The watchdog has also stated that a further risk assessment confirmed that the life risk of cancer resulting from exposure to NDMA levels detected in valsartan was considered low.

A representative of Torrent Pharmaceuticals declined to comment.


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