NDMA & NDEA: What’s the Difference?

In July 2018, the FDA recalled certain batches of valsartan after investigators found N-Nitrosimethylamine (NDMA) had contaminated the drug. Since then, several batches of valsartan, irbesartan, and losartan have been recalled due to NDMA and N-Nitrosodiethylamine (NDEA) contamination. These nitrosamines are classified as probable human carcinogens.

How Are They Similar?

NDMA and NDEA are both classified by the Environmental Protection Agency as probable human carcinogens. Exposure to these carcinogens can cause tumors to develop in the respiratory tract. Specifically, an individual may develop liver, stomach, colorectal, pancreatic, prostate, esophageal, and/or intestinal cancer. Exposure has also been linked to non-hodgkin’s lymphoma, leukemia, and multiple myeloma.

What’s the Difference?

The main difference between NDMA and NDEA is toxicity. NDEA happens to be about three times more toxic than NDMA.

What Should I Do?

If you or a loved one took a recalled valsartan, irbesartan, or losartan and developed prostate cancer (before age 60), lower esophageal cancer, non-hodgkins lymphoma, leukemia, multiple myeloma, colon, stomach, intestinal, or pancreatic cancer, please fill out the form below. We deliver the Gold standard advocacy you deserve.

Valsartan Side Effects

In July 2018, the blood pressure medication Valsartan was recalled due to contamination with a probable human carcinogen. The FDA estimates that between 3 and 3.7 million people have been prescribed Valsartan over the last three years. Many are scared and wondering what side effects this contaminated medication could cause.

What Are the Valsartan Side Effects?

There are several risks associated with Valsartan that are warned about in the drug label. However, the recent discovery of N-nitrosodimethylamine (NDMA) contamination found in suppliers’ plants has added a terrifying new side effect: cancer. NDMA is a probable human carcinogen. Researchers use NDMA to induce cancer in animal studies and have found in various species, including rats and mice, that tumors developed in the liver, respiratory tract, and blood vessels after being induced with NDMA.

Valsartan side effects due to NDMA contamination include cancers of the liver, pancreas, prostate, esophagus, colon/intestines, and stomach. Contamination has also been linked to non-hodgkin’s Lymphoma, leukemia, and multiple myeloma.

What Should I Do If My Valsartan Was Part of the Recall?

If you or a loved one received a Valsartan recall letter, you should speak with your doctor immediately. FDA drug safety officials have alerted doctors and physicians about this, but they recommend you do not stop taking your medication without first contacting your physician. You can see which Valsartan medications were recalled here. If you or a loved one took recalled Valsartan and developed liver cancer, stomach cancer, colorectal cancer, intestinal cancer, esophageal cancer, prostate cancer, pancreatic cancer, non-hodgkin’s lymphoma, leukemia, or multiple myeloma, contact the Valsartan attorneys at GoldenbergLaw.

At GoldenbergLaw, every client matters to us. We understand how terrifying and difficult this time can be for you, and that’s why we want to help you. Contact our Valsartan attorneys at GoldenbergLaw for a free case evaluation, and leave the sleepless nights to us.

 

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Five Things You Should Know About NDMA Contamination in Valsartan

Numerous lots of the drug Valsartan have recently been recalled by the FDA due to NDMA contamination. Read below to learn what you should know about this contamination and FDA recall.

1. What is NDMA?

N-nitrosodimethylamine (NDMA) is a probable human carcinogen classified by the Environmental Protection Agency (EPA) as a semi-volatile organic chemical. Changes to the process used to manufacture Valsartan led to dangerous NDMA contamination of the drug.

2. Which Lots of Valsartan Were Recalled?

The list of Valsartan lots recalled due to dangerous NDMA contamination continues to grow. The FDA continues to update this list to reflect the specific lots included in the Valsartan recall.

3. What Types of Cancer Does Valsartan Cause?

NDMA may increase the risk of developing cancerous tumors. Research has shown that NDMA is linked to liver cancer, stomach cancer, colorectal cancer, intestinal cancer, esophageal cancer, prostate cancer, pancreatic cancer, non-hodgkin’s lymphoma, leukemia, and multiple myeloma.

4. Where Are the Drugs Coming From?

The NDMA-contaminated Valsartan was produced by three facilities: Zhejiang Huahai Pharmaceuticals in China, Hetero Labs Limited in India, and Zhejiang Tianyu in China.

5. What Should I Do Now?

If you or a loved one took Valsartan and was later diagnosed with cancer, contact GoldenbergLaw for a free consultation. We have over 30 years of experience in product liability litigation, and our attorneys hold several leadership positions in major drug and device lawsuits across the country. Call us. Leave the sleepless nights to us.

Helpful Links:

Fact Sheet about NDMA from the Environmental Protection Agency https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf

Recalled Valsartan products from the FDA: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf