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Regulatory Focus™ > News Articles > 8 > EMA Updates on Recalled Valsartan Medicines

EMA Updates on Recalled Valsartan Medicines

Posted 02 August 2018 | By Ana Mulero 

EMA Updates on Recalled Valsartan Medicines

An initial health risk assessment conducted by the European Medicines Agency (EMA) projects a hypothetical increase in cancer cases among patients who took certain medicines with a Chinese company’s active substance that was previously found to contain an impurity.
“There could be one extra case of cancer for every 5,000 patients” who took valsartan supplied by Zhejiang Huahai Pharmaceuticals at its highest dosage each day for seven years, EMA reported on Thursday. The estimates are based on the average levels of the chemical impurity N-nitrosodimethylamine (NDMA) that the company detected in the valsartan medicines.
NDMA had been classified as a probable human carcinogen prior to the investigation that resulted in an international recall of the affected blood pressure and heart medicines. 
“The possible cancer risk has been extrapolated from animal studies and should be considered in the context of the lifetime risk of cancer in the EU (1 in 3) and NDMA exposure from other sources,” EMA clarified. “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 recall was initiated throughout Europe in early July, followed by the US Food and Drug Administration (FDA). FDA concluded in its analysis, released last week, that “some levels of the impurity may have been in the valsartan-containing products for as long as four years.”
EMA’s ongoing investigation also requires all drug manufacturers that have used Zhejiang Huahai Pharmaceuticals’ valsartan to test samples to determine NDMA levels in finished medicines. The agency intends to provide another update once these data area available.

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