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NDMA-Contaminated Valsartan and Cancer Risk

The U.S. Food and Drug Administration recalled some batches of valsartan contaminated with the potentially cancer-causing agent N-nitrosodimethylamine (NDMA). The agency estimates that for every 8,000 people that took the highest dose of valsartan for four years there may be one additional case of cancer. NDMA is a known environmental contaminant found in water and foods.

People who took batches of valsartan contaminated with N-nitrosodimethylamine (NDMA), a toxic chemical contaminant, may be at an increased risk for developing cancer. Studies compiled in a report published by the World Health Organization showed that NDMA exposure has resulted in the development of tumors in animals. The report noted that the International Agency for Research on Cancer (IARC) had upgraded NDMA from “possibly carcinogenic to humans” to “probably carcinogenic to humans” based on available evidence.

A 2018 Danish study in the BMJ did not show an increase in the short-term risk of cancer in people who took the tainted valsartan. But it provides short-term reassurance only, experts say.

“There hasn't been long enough follow-up to really see a [cancer] signal. So while I'm reassured that they didn't find one, I don't think it means that patients are completely out of the woods.”

Source: Dr. Erin Michos, Johns Hopkins Medicine

Millions of Americans take valsartan to treat high blood pressure or other heart problems. The U.S. Food and Drug Administration announced a recall of half of the supply of valsartan in the U.S. because of NDMA contamination. Cancer is not a typical side effect of valsartan, but people exposed to contaminated drugs may have a higher risk of developing cancer from NDMA exposure.

In September 2018, the FDA, European Medicines Agency and Health Canada announced it found a second cancer-causing chemical in the same family as NDMA called N-nitrosodiethylamine (NDEA).

Lawyers are filing valsartan lawsuits for people who suffered digestive tract cancers after taking valsartan. These include liver, stomach, colorectal, bladder and pancreatic cancer.

Were you or a loved one diagnosed with cancer or liver damage after taking Valsartan? Get a Free Case Review

How Much NDMA Is in Valsartan?

The average NDMA levels detected in contaminated valsartan products from one supplier, Zhejiang Huahai Pharmaceuticals, was 60 parts per million (ppm). This is more than 1,000 times the amount most people consume in drinking water daily.

The Agency for Toxic Substances & Disease Registry released a public health statement in 2015 claiming that animals who suffered liver disease, cancer and death had consumed water containing 5 to 50 ppm of NDMA and food containing 5 to 100 ppm.

Zhejiang Huahai, the Chinese valsartan manufacturer, believes the NDMA contamination occurred after it changed its manufacturing process in 2012.

Diagnosed with liver damage, tumors or cancer after taking valsartan? Get a Free Case Review
Replay Video
Registered Nurse Amy Keller explains valsartan's link to NDMA and cancer.

Cancer Risk After Exposure

The FDA estimated that there would be one extra case of cancer for every 8,000 patients taking the highest dose (320 mg) of contaminated valsartan every day for four years. The European Medicines Agency offered a similar calculation of 1 in 5,000 for people treated with 320 mg daily for seven years.

Valsartan Study Fact
Danish researchers found contaminated valsartan slightly increased the risk for colorectal and uterine cancer.

The 2018 Danish study found a low short-term risk of cancer. It followed 5,150 people with no history of cancer who started taking valsartan between Jan. 1, 2012, and June 30, 2017.

Researchers found 104 cancers in people not exposed to NDMA and 198 cancers in people exposed to tainted valsartan. But authors said researchers need more studies to determine long-term risk.

Lawsuit Information
Like Valsartan, Zantac was also found to contain unacceptable levels of NDMA. People who developed cancer after taking the drug are suing manufacturers. Learn more.
View Lawsuits

Types of Cancer Caused by Contaminated Valsartan

Exposure to NDMA can cause cancer in animals and in humans, but the EPA says there are no reports of cancer in humans. However, a study published in Occupational and Environmental Medicine found that rubber workers exposed to NDMA in factories had an increase in cancer of the esophagus, oral cavity and pharynx.

“Although there are no reports of NDMA causing cancer in humans, it is reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.”

Source: Agency for Toxic Substances & Disease Registry

In animals, NDMA caused tumors in the liver, respiratory tract, kidneys and blood vessels. Animals exposed to NDMA suffered liver damage and cancer often leading to internal bleeding and death. Treatment for each type of cancer depends on its location and how far it has spread.

Cancers that may be associated with NDMA include:
  • Liver cancer
  • Kidney cancer
  • Colorectal cancer
  • Stomach or gastric cancer
  • Bladder cancer
  • Pancreatic cancer
  • Lung cancer
  • Nasal cancer

Please seek the advice of a medical professional before making health care decisions.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
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  1. Agency for Toxic Substances & Disease Registry. (1989). Public Health Statement for n-Nitrosodimethylamine. Retrieved from
  2. Banzi, R. & Bertele, V. (2018). Regulatory response to contaminated valsartan. Retrieved from
  3. Brennan, Z. (2018, September 14). Updated: FDA and Health Canada Spot Second Impurity in Valsartan. Retrieved from
  4. EPA. (2017, November). Technical Fact Sheet — NDMA. Retrieved from
  5. European Medicines Agency. (2018, February 8). Update on review of recalled valsartan medicines. Retrieved from
  6. FDA. (2018, September 13). FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products. Retrieved from
  7. FDA. (2018). FDA updates on valsartan. Retrieved from
  8. Health Canada. (2011). Guidelines for Canadian Drinking Water Quality. Retrieved from
  9. Howard, J. (2018, September 12). After valsartan recall, study offers 'modest reassurance' on short-term cancer risk. Retrieved from
  10. Muller, B. (2010, October 1). The Danger of the Swimming Pool: Nitrosamine Carcinogens. Retrieved from
  11. National Library of Medicine. (n.d.). N-NITROSODIMETHYLAMINE. Retrieved from
  12. Pottegard, A. et al. (2018, September 9). Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study. Retrieved from
  13. Straif, K. et al. (2000). Exposure to high concentrations of nitrosamines and cancer mortality among a cohort of rubber workers. Retrieved from
  14. World Health Organization. (2008). N-Nitrosodimethylamine (NDMA). Retrieved from
  15. World Health Organization. (2006). N-Nitrosodimethylamine in drinking-water Retrieved from
View All Sources
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