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The US Food and Drug Administration found a second carcinogenic impurity in three batches of valsartan, a popular blood pressure medication. The lots were all sold through Torrent Pharmaceuticals. The discovery may result in additional recalls or warnings for patients taking valsartan.
The latest FDA tests revealed that three lots of Torrent Pharmaceutical's valsartan contained NDEA (N-nitrosodiethylamine). NDEA is a known carcinogen in animals and suspected to cause cancer in humans. Torrent lots were already being recalled for NDMA contamination when FDA tests discovered the second impurity. NDMA is also a probable cause of cancer in humans.
Cancer is not a typical side effect of valsartan. But the contamination could increase the risk of cancer for people taking the drug.
Valsartan is a widely used generic medicine. The summer recalls have raised questions about NDMA and cancer risks in people taking this drug. About 3 million Americans take valsartan for high blood pressure or related heart problems. The European Medicines Agency estimates cancer risk from the maximum dose of NDMA-contaminated valsartan at 1 in 5,000. This could still mean hundreds of new cases of cancer in the United States. The first lawsuits against NDMA contamination were filed at the end of August.
Dozens of companies have announced Valsartan recalls
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Several pharmaceutical companies have announced that valsartan remembers from July 2018 after discovering NDMA contamination in their valsartan products.
As of August 27, more than 75 products sold under more than 15 brands were being recalled due to NDMA contamination. The FDA keeps a list of the recalled valsartan products. It also has a list of valsartan products that are not recalled.
NDMA is a chemical by-product of fuel fabrication and pesticides. Contaminated valsartan has been attributed to the manufacturing process of valsartan in at least three plants in China and India. The factories manufacture valsartan for several pharmaceutical companies. They may have produced contaminated valsartan since 2012.
The widespread contamination of NDMA has triggered an aggressive FDA investigation into the manufacture of Valsartan. The agency also tested for other impurities. This is how the FDA discovered NDEA contamination.
FDA examines the latest risks of valsartan for patients
The additional risk for patients of the newly discovered NDEA impurity is still unclear. The FDA has promised a risk analysis in the coming days. The FDA also announced that it would continue to test all valsartan-based products for NDEA impurities. The agency said it was working on methods that companies should use to detect NDEA contamination. Like NDMA, NDEA contamination comes from chemical reactions and manufacturing processes.
The FDA said that people should continue to take the recalled valsartan up to talk to their doctor about an alternative. But the agency also said anyone taking the recalled medication should immediately consult their doctor or pharmacist if they have not already done so. All valsartan products are not contaminated. A doctor or pharmacist may be able to change a patient's prescription to a version that is not affected.
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