The Food and Drug Administration (FDA) is trying to get a handle on unacceptable levels of dangerous nitrosamine impurities that have been turning up in various pharmaceutical products in recent months. The agency announced Tuesday that it had released new guidance to help drug companies detect and prevent these impurities from getting into their drugs.
The most notorious nitosamine impurity is N-nitrosodimethylamine, or NDMA, classified as a probable human carcinogen. Its presence in the blood pressure medicine valsartan and diabetes drug metformin has led to numerous recalls of those products. And, unsafe levels in the heartburn drug Zantac and other ranitidine products forced the FDA in April to withdraw all Zantac products from the market.
“This guidance recommends steps including a comprehensive risk assessment strategy and other actions that manufacturers can take to reduce or prevent the presence of nitrosamine impurities in their drug,” the FDA said.
NDMA is a known environmental contaminant that can be found in water and foods like meats, dairy products, and vegetables. The FDA says that consuming up to 96 nanograms of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. However, “genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above certain levels and over long periods of time,” the agency said.
The FDA said that the NDMA in the blood pressure drug valsartan was likely due to the way the active substance was manufactured. But its presence in Zantac is different. In April, when the FDA began the process to pull Zantac from the market, the agency said that it had determined that levels of NDMA in Zantac seem to increase to unsafe levels under normal storage conditions, such as when exposed to higher temperatures or a longer shelf life.
The U.S. Department of Justice launched an investigation into how much Zantac makers Sanofi-Aventis US LLC and GlaxoSmithKline LLC knew about the NDMA in their products, and whether the presence of the impurity in the drug causes cancer in users.
Some cancer victims have also taken measures into their own hands and have filed lawsuits against the drug companies. Some cancers that may be related to NDMA exposure include stomach, small intestine, bladder, kidney, colorectal, esophageal, prostate, and pancreatic, as well as leukemia, non-Hodgkin’s lymphoma, and multiple myeloma.
If you or a loved one was a regular user of Zantac or any other product containing ranitidine and have been diagnosed with cancer, we would like to talk with you. Contact Frank Woodson, one of our leading pharmaceutical attorneys in charge of Zantac cancer claims.