Valsartan Recalled Over Potential to Cause Cancer

Valsartan is a prescription medication used for treatment of high blood pressure and congestive heart failure. Over 1.5 million people in the United States are prescribed Valsartan every year.

On July 13, 2018, the US Food and Drug Administration (FDA) issued a recall of Valsartan when it was discovered that the medication contained NDMA (N-nitrosodimenthylamine), a carcinogenic and liver-damaging impurity. NDMA is a yellow, oily liquid that is unintentionally formed during the Valsartan manufacturing process and is so toxic that clinical trials of its effect on humans cannot be safely performed. NDMA can enter the body through breathing, eating or drinking, and once metabolized in the liver, is sent to other organs very quickly.

The FDA’s Valsartan recall is the largest Class 1 pharmaceutical recall in US history, requiring notice of the recall to be sent directly to the consumers who have been prescribed tainted batches of the medication. The FDA is conducting an ongoing investigation into the introduction of Valsartan containing NDMA into the United States, with additional tests, studies and reports on expected to be issued in the coming months.

Scientific studies have linked NDMA to digestive tract cancers including liver, kidney, colorectal, stomach, bladder and pancreatic cancer. NDMA has also been shown to cause liver damage other than cancer that results in hospitalization.

Our firm is currently investigating cases against the manufacturers of this drug. Please visit our website for more information about this developing litigation, and don’t hesitate to contact our attorneys if you or a family member have been diagnosed with a digestive tract cancer or liver damage after taking Valsartan.

https://whitleylawfirm.com/blog/fda-recalls-blood-pressure-medication-for-potential-cancer-risk/