On July 13, 2018, the United States Food and Drug Administration (FDA) sent out alerts to health care professionals and patients regarding a voluntary recall of medications containing valsartan, after an impurity was found. The impurity is an organic chemical known as nitrosodimethylamine (“NDMA”). NDMA is classified as a probable human carcinogen. According to the FDA release  the presence of NDMA was unexpected and is suspected to have been caused by a change in the way the ingredient valsartan was manufactured.
The FDA’s review is ongoing and includes assessing the possible effects of taking valsartan tainted with N-nitrosodimethylamine, a known carcinogen. Nitrosamines are known as some of the most potent groups of carcinogens. In a test of 300 compounds within the Nitrosamine family about 90% of them have been found to be carcinogenic in laboratory animals. N-nitrosodimethylamine is among this chemical group and is known to cause liver cancer, as well as induce tumors in the tongue, esophagus, lung, pancreas, liver, kidney and bladder. The FDA has urged patients who took the tainted medications to contact their health care professionals including the pharmacists who dispensed the medication and/or doctor who prescribed the medication.
Currently, the companies recalling their lots of nonexpired products which contain the ingredient valsartan are; Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceutical Industries Ltd. According to the FDA’s release, these companies were supplied the N-nitrosodimethylamine tainted valsartan by Zhejianghuahai Pharmaceuticals, a Chinese manufacturing company.
If you or a loved one has developed cancer after you have taken a medication which contained the N-nitrosodimethylamine tainted valsartan, the law firm of Babbitt & Johnson is willing to speak with you about your potential legal options.