Valsartan, a common drug used to control hypertension and heart failure, is being recalled in 22 counties due to concerns its active pharmaceutical ingredient, N-Nitrosodimethylamine (NDMA), a known carcinogen, poses a cancer risk.
The recalled batches were supplied by China's Zhejiang Huahai Pharmaceuticals.
“A recall is underway across Europe following recent and emerging information that an impurity has been identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China,” read an issued statement from the Medicines and Healthcare products Regulatory Agency in the U.K. “This facility has supplied the manufacturers with the valsartan active substance. The impurity (N-nitrosodimethylamine), which may have carcinogenic potential, is a result of a change in the manufacturing process. This active substance is used in a number of medicines marketed in Europe.”
The Agency for Toxic Substances & Disease Registry (ATSDR), part of the Centers for Disease Control and Prevention, noted NDMA was originally produced in the U.S. and was used to make rocket fuel. However, this use was stopped as unusually high levels of NDMA were detected in air, water and soil samples near a rocket fuel manufacturing plant. The ATSDR also noted in addition to liver and lung cancer, NDMA consumption may also cause severe liver damage accompanied by internal bleeding and can also cause death.
In addition to the E.U., other countries affected by the recall include Canada and the UAE. The U.S. FDA has yet to issue a recall.