EMA Provides Update on Recalled Valsartan Drugs Containing Carcinogenic Impurity

A European Medicines Agency initial health risk assessment found cancer cases were likely to increase among patients who used valsartan supplied by Chinese API manufacturer Zhejiang Huahai Pharmaceuticals.

The agency projected there could be one extra case of cancer for every 5,000 patients who took valsartan supplied by the company at its highest dosage every day for seven years, based on the average levels of the impurity NDMA detective in the drugs. NDMA was previously classified as a probable carcinogen, leading to an international recall of affected drugs.

 “This preliminary estimate is based on the assumption that the NDMA present in the active substance is carried over in the final product in the same amount,” the EMA said. A recall of affected drugs took place in early July in Europe.