The European Medicines Agency (EMA) and the FDA said late last week a second toxin that may cause cancer has been detected in valsartan—a common heart drug that has already been recalled in about two dozen countries due to the presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen.
The NDMA contaminant has been linked to a change in the manufacturing process in 2012 for Chinese drugmaker Zhejang Huahai Pharmaceuticals, while the newly identified chemical—N-nitrosodiethylamine—was detected in lots produced before 2012. More than 50 companies around the world have recalled generic products made with the NDMA-tainted valsartan, according to a Reuters report.
“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,” EMA 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 FDA found NDEA in three lots of valsartan produced by Torrent Pharmaceuticals, which uses active ingredients from Zhejang Huahai, Reuters reported.
The news comes on the heels of a study which researchers said was “generally reassuring” in that NDMA-tainted valsartan wasn’t linked to a significantly increased short-term risk of cancer. However, the authors acknowledged longer-term follow-up is necessary to fully assess risks associated with cumulative exposure to the contaminated medication.
According to Reuters, valsartan had global sales of 10.4 billion pills last year. People with high blood pressure and congestive heart failure commonly use the drug.