Drugmakers Finding Ways To Prevent NDMA Contamination

Drugmakers Finding Ways To Prevent NDMA Contamination

Introduction

The rising number of recalls, over the past years, on pharmaceutical products containing the cancer-causing chemical N-nitrosodimethylamine (NDMA) has made the drug industry to look for ways to prevent contamination.

Popular medication drugs, including the widely used heartburn and blood pressure drugs, Zantac and generic valsartan respectively, are facing many lawsuits and class action after the levels of NDMA in the pills exceed the threshold determined to be safe by federal regulators.

The pharmaceutical companies are facing pressure from the FDA to find solutions to prevent contamination, both from NDMA and other harmful contaminants as well.

The lawsuit against Zantac, valsartan, and other recalled drugs claim that the long term exposure to NDMA causes liver cancer, stomach cancer, small intestine cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other cancers.

Nearly 229 Zantac lawsuits are pending in the Southern District of Florida, which includes both personal injury lawsuits as well as class action complaints. The lawsuits are consolidated before U.S. District Judge Robin L in Florida under MDL No: 2924, for coordinated discovery and pretrial proceedings.

Nearly 130 product liability lawsuits and class action claims involving valsartan are currently pending in the federal court system. Valsartan claims are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.

The U.S. Food and Drug Administration (FDA) has even requested the manufacturers to discontinue all the versions of Zantac from the market due to its risk to public health. It is one of the top-selling products in the U.S. markets for decades. Earlier the people were not aware of the high levels of NDMA produced by Zantac, but the testing of independent pharmacy, Valisure highlighted the high level of exposure limit set by the FDA in terms of NDMA that causes cancer.