The FDA recently determined the presence of a second type of impurity causing contaminated valsartan.

The newer source of valsartan contamination is reportedly N-nitrosodiethylamine (NDEA). The second contaminate is linked to cancer in humans and is known to be carcinogenic to animals. It was identified by the government agency in the popular blood pressure medicine.

All lots affected by the second possible valsartan contamination were reportedly sold by the Torrent Pharmaceuticals company. This is the second discovery of contaminated valsartan and might lead to additional warnings or recalls for patients taking the drug.

Prior to the release of this information about the second source of valsartan contamination, the FDA says that it completed testing that identified the presence of NDEA.

The second valsartan contamination is of concern for patients taking the drug because those lots of the medicine were already recalled due to NDMA contamination. As noted above, NDEA is currently suspected of being a cancer-causing agent in humans and is known to cause cancer in animals. NDMA is also suspected of causing cancer in humans.

It is important to note that the development of cancer is not a known side effect of valsartan. However, the substances reportedly in the contaminated valsartan could increase the risk of developing cancer in patients taking affected lots of the heart pressure drug.

The popular generic drug is taken by approximately three million Americans. Most of these patients could have received contaminated valsartan.

Research presented by the European Medicines Agency estimates a one in 5,000 risk for cancer. However, due to the sheer number of people who take drugs in the affected lots in the U.S., contaminated valsartan could affect hundreds of patients.

The first lawsuits related to the risks presented by contaminated valsartan were filed in August 2018, shortly after many companies announced recalls of valsartan due to the presence of NDMA. At least 75 products being sold under a minimum of 15 brand names were recalled to the NDMA valsartan contamination.

Not all valsartan products were recalled, and the FDA has a list of which ones have been pulled from the market due to contamination risks. Contaminated valsartan batches may date back as far as 2012 and are linked to three factories in India and China. Allegedly, the valsartan contamination is tied to a change in the manufacturing processes.

Once the NDMA contamination was publicized, the FDA initiated an investigation into whether or not other impurities exposed patients to risks. This led to the discovery of NDEA contaminated valsartan.

Now, the government agency is creating a risk analysis about what this means for patients. The agency says it also plans to continue testing for other impurities linked to NDEA. The FDA also plans to release information about methods for identifying contamination with NDEA. According to the initial results from the FDA’s investigation, the NDEA contamination likely comes from the same source as the NDMA contamination during the manufacturing process.

Any patients currently taking valsartan should consider speaking to their physician about whether or not they should continue using the drugs. Since not all valsartan products are affected by contamination, users of the drug should check the FDA list to determine if their medicine is on the recall list. Some patients could receive another form of valsartan that is not on the contaminated list.