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EMA and FDA find additional impurity in valsartan products

by JMC on September 18, 2018

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have reported the presence of a second impurity in valsartan products.

The new impurity is called N-Nitrosodiethylamine (NDEA) and it has been found in several batches of drugs with valsartan as the active pharmaceutical ingredient (API).

Both the European and US regulatory authorities recalled certain valsartan drugs in July this year after finding traces of a potential human carcinogen, N-nitrosodimethylamine (NDMA) in the products.

NDEA is also a known animal and suspected human carcinogen. The FDA discovered this impurity in three lots of Torrent Pharmaceuticals’ recalled valsartan products.

In addition, Zhejiang Huahai Pharmaceuticals (ZHP) reported the presence of NDEA in multiple batches of its valsartan API.

The FDA said it would re-test all valsartan API and products, including the recalled products and those being marketed in the US. NDEA was observed in select ZHP valsartan API, and in 160mg and 320mg tablets made by Torrent using ZHP’s API.

However, not all products formulated using the ZHP valsartan API contain the NDEA impurity.

“Our scientists are testing these products to better understand these impurities and to ensure they’re not present in other products.”

EMA is also assessing whether NDEA is an impurity in valsartan products marketed in Europe.

FDA commissioner Scott Gottlieb said: “As we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they’re not present in other products.

“We’ll also continue to work with global regulatory agencies to learn as much as we can about how these impurities came about and how they may affect patients’ health around the globe.”

According to EMA, the life-time risk of cancer in patients who used affected valsartan drugs is low. People who have taken lower doses or used the medicine for shorter duration are considered to be at an even lower risk.

Source: EMA and FDA find additional impurity in valsartan products

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