CONTAMINATED VALSARTAN PRODUCTS: ALLEGED INCREASE RISK OF CANCER
The European Medicines Agency (EMA) initiated concerns over the drug Valsartan on July 5, 2018. Some patients taking Valsartan, a common blood pressure and heart medication, were exposed to an impurity called N-nitrosodimethylamine (NDMA) which has been linked to cancer.
Valsartan products containing the impurity, which far exceeded regulatory exposure limits, were made by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China. According to EMA, manufacturing changes of Valsartan in 2012 likely led to the NDMA impurity which was not detected by tests routinely performed by the drug makers.
VALSARTAN RECALL
Affected Valsartan products have been removed from the market in Europe and the US. You can find updates on Valsartan recalls on the U.S. Food & Drug Administration website.
Valsartan and Colorectal and Uterine Cancer
The BMJ recently “conducted a cohort study comparing cancer outcomes in users of potentially NDMA contaminated Valsartan products with users of Valsartan products assumed free from this contaminant.” They compared data from Danish nationwide registries of 5150 Valsartan users for the study period of January 2012 to June 2018.
While The BMJ’s findings did not show an overall marked increase in cancer risk for those exposed to NDMA, it did reveal a statistically significant increase in colorectal and uterine cancer. The study showed those exposed to potentially NDMA contaminated Valsartan products had a 46% increased risk for colorectal cancer and an 81% increased risk for uterine cancer. The study also found there was no evidence of a dose response, meaning there was not an increased risk with more exposure – just exposure itself.
FDA Finds Additional Impurity
On September 13, 2018, the FDA announced an additional impurity found in three lots of Torrent Pharmaceuticals’ recalled Valsartan. The second impurity, N-Nitrosodiethylamine (NDEA), is also an alleged human carcinogen
VALSARTAN CANCER LAWSUIT
The Potts Law Firm is currently representing victims who have suffered health complications after using Valsartan. If you or a loved one have experienced injuries from the Valsartan drug and would like to seek compensation for damages, it is important to speak with an attorney who is experienced in dangerous drug litigation.
When represented by the Potts Law Firm, your case will be examined both legally and medically. Our experienced medical team will examine your medical records, while our legal professionals will assist you through the entire litigation process.
Contact the Potts Law Firm today to schedule a free legal consultation at (888) 902-6245.