JOHANNESBURG – South Africa has recalled a number of high blood pressure and heart drugs containing an ingredient manufactured in bulk by a Chinese company following detection of an impurity that may cause cancer, its health authority said on Tuesday.
This follows similar moves across Europe after the European Medicines Agency (EMA) raised the potential cancer risk from the Chinese supplied valsartan on July 5 and began recalling medicines containing the ingredient from China’s Zhejiang Huahai Pharmaceutical.
“This review was triggered because of the detection of an impurity, N-nitrosodimethylamine (NDMA) in the valsartan active substance which the company supplies,” the South African Health Products Regulatory Authority said in a statement.
The health authority said not all valsartan-contaning medicines are affected, but only Dynaval Co tablets.
Valsartan-containing medicines are commonly used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke, and those who have had heart failure or a recent heart attack.
Zhejiang Huahai has already acknowledged that there was an impurity in some of its valsartan, which it said had sales of $50 million in 2017 and added on Monday that countries were recalling the products as a precautionary measure.(Reuters)