BEIJING (Reuters) – The Chinese bulk manufacturer of the common blood and heart drug valsartan said it was recalling the product from consumers in the United States and would halt supplies to the country, after an impurity linked to cancer had been detected.
Earlier this week, European regulators said the problem likely dates to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical in 2012, suggesting that many patients could potentially have been exposed to cancer risk.
Zhejiang Huahai Pharmaceutical said in a statement late on Thursday that its U.S. unit was contacting distributors and customers in the United States for product return, and said it could not accurately estimate the loss caused by the recall.
“The company has decided to recall its valsartan products from U.S. customers after communicating with the U.S. Food and Drug Administration,” it said.
The European Medicines Agency (EMA) first raised the potential cancer risk from the Chinese supplied valsartan on July 5 and began recalling medicines containing valsartan from Zhejiang Huahai.
Last week, the U.S. Food and Drug Administration also took action to recall affected valsartan-containing medicines.
The EMA said this week it was working to establish how long and at what levels patients might have been exposed to the impurity known as NDMA, which is classified as a probable human carcinogen. Based on results from laboratory tests, it may cause cancer with long-term use.
Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines supplied by various companies.
(Reporting by Min Zhang and Tony Munroe in Beijing; Editing by Susan Fenton)