A new lot of valsartan drugs has been recalled due to potential contamination. The detection of trace amounts of NDEA has led to the recall of 80 different batches of valsartan drugs, including valsartan tablets, amlodipine valsartan tablets, and valsartan HCTZ tablets.

NDEA is an unexpected impurity in the valsartan drugs included in the most recent recall. Numerous valsartan drugs have already been subjected to a recall after investigations of manufacturing plants abroad identified the potentially cancer causing impurities in certain drugs that contained valsartan.

NDEA is a substance that occurs in drinking water, air pollution, industrial processes, and certain foods, but has been categorized as a potential human carcinogen by the International Agency for Research on Cancer.

Only recently have studies attempted to define the possibility of cancer development due to the recalled valsartan drugs. According to BMJ, one study using a Danish cohort identified that further research needs to be completed with a larger sample size to determine the possibility of cancer risk development.

The researchers in that study were only able to establish that there was a non-statistically significant risk with uterine and colorectal cancers.

The FDA has previously warned about recalled valsartan drugs as many of these medications containing valsartan have already been removed from the market. All of these valsartan drugs have been recalled due to the potential of NDEA contamination.

Fortune reports that three companies began recalling valsartan drugs in July 2018 and related blood pressure medications have also been recalled over possible concerns of trace amounts of NDEA inside.

Those individuals who are currently taking recalled valsartan drugs are advised to communicate directly with their health care providers while still continuing to take the medication as prescribed. Discontinuation of a blood pressure medication including the recalled valsartan drugs could cause critical medical issues if not monitored closely by a doctor.

The FDA is currently facing more pressure to step in on these contamination issues given that so many valsartan drugs were connected to the recalls. The issues have also put the spotlight on overseas manufacturing processes.

In June 2018, regulators shared findings that NDEA and NDMA had been found in batches of blood pressure medications made by Chinese companies that were shipping their finished product to the US. That first finding led to international recalls of other products. Prior to that discovery, NDMA and NDEA were not tested for in the manufacturing process.

Several months after the original recall notice was shared following the contamination of discovery, multiple makers of products with Valsartan identified that their final products had the contaminants inside too.

The FDA has shared that the impurities in the valsartan products could have been happening for at least four years back.

It is not yet known how these recalled valsartan drugs that were already taken by patients could influence a patient’s overall risk for development of cancer, but many physicians are looking for alternative treatment options and medications to address the underlying blood pressure concerns without the possibility of contamination due to NDEA.