The European Medicines Agency (EMA) has expanded its investigation of the recently-recalled potentially-contaminated valsartan products to include another possible contaminant.
The EMA review was initiated in July after it emerged that valsartan products supplied by Zhejiang Huahai Pharmaceuticals might contain N-nitrosodimethylamine (NDMA), which is considered a probable human carcinogen. It is believed the impurity was a side product of a manufacturing process introduced at the facility in 2012. Since then, another manufacturer has been added to the review - Zhejiang Tianyu.
However, the EMA is now also assessing the impact of a related substance, N‑nitrosodiethylamine (NDEA), which has been detected in valsartan made by Zhejiang Huahai.
Data on levels of NDEA are currently limited, and the EMA says it will provide further information on the impact once more details become available.
The EMA recently reported that data available to date suggest the life-time risk of cancer with NDMA is in the order of one in 5,000 adult patients who had been receiving the affected valsartan medicine at the highest dose (320 mg) every day from July 2012 to July 2018.
The risk is lower for patients receiving valsartan produced by Zhejiang Tianyu, which had smaller amounts of NDMA.