Valsartan and Contamination with NDMA

Valsartan contaminated with NDMA has been recalled. NDMA is a "probable carcinogen" that has contaminated many batches of generic Valsartan pills for years prior to the 2018 recall.

People suffering from liver damage after taking Valsartan or cancer after taking Valsartan may be able to sue the Valsartan manufactures. Plaintiffs in Valsartan lawsuits could be eligible to recover large financial damages to compensate for their losses, including pain and suffering.

In this article, our personal injury lawyers will discuss:

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Several batches of Valsartan have been recalled for containing the "probable carcinogen" NDMA.

1. NDMA definition

NDMA is short for the genotoxin N-Nitrosodimethylamine (a.k.a. dimethylnitrosamine/ DMN).

NDMA is a by-product of various industrial processes. For instance, low levels are generally present in meat that has been cured or smoked. It can also be a by-product of chlorinating water or creating a certain ingredient of rocket fuel.

An organic chemical, NDMA is generally considered to be a carcinogen (cancer-causing) by the EPA. And the U.S. Code classifies it as an "extremely hazardous substance."1 When scientists study cancer in animals, it is typical to inject them with NDMA to cause the animals to develop cancer.

NDMA is yellow, oily, water-soluble, and semi-volatile. It is particularly toxic to the liver. In sufficiently high doses, it is poisonous.

It is considered safe to consume only up to a threshold of 96 nanograms of NDMA per day. The more a person consumes, the higher the chance he/she will develop cancer. Consuming merely 400 nanograms can double a person's cancer risk.2

(Note that NDMA is very different from MDNA, which refers to the drug commonly known as ecstasy).

2. Valsartan contamination with NDMA

In 2018, several batches of generic Valsartan was found to contain high levels of NDMA. Of the four million Valsartan users per year, 60- to 70% of their pills are contaminated.

Some of the batches were contaminated with up to 20,000 nanograms of NDMA. This can raise the user's cancer risk by 50- to 100 percent.

The following are the main pharmaceutical companies that have recalled their Valsartan products:

The contaminated lots were manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China. The European Medicines Agency discovered the impurity while it was testing the drug. In addition to the United States, contaminated pills were sent to:

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Valsartan contamination with NDMA can result in people developing liver damage and/or various cancers.
  • Austria
  • Bahrain
  • Belgium
  • Bosnia
  • Bulgaria
  • Canada
  • Croatia
  • Finland
  • France
  • Germany
  • Greece
  • Herzegovina
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Malta
  • the Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden3

Learn more about Valsartan recalls and warnings.

3. Checking if your Valsartan prescription has been recalled

To check if your specific batch of Valsartan has been recalled, check the pill bottle and note down its:

  • 10-digit NDC (national drug code) number,
  • lot number, and
  • expiration date

Then go to the FDA website and search to see if your prescription matches. If it does, your bottle likely contains pills contaminated with NDMA.

Not all generic Valsartan products have NDMA (or unacceptably high levels of it). For instance, Novartis's brand-name Valsartan (called Diovan) does not contain the impurity and has not been recalled.4

4. NDMA injuries from Valsartan

Common symptoms of excessive exposure to NDMA include:

  • headaches
  • dizziness
  • fever
  • nausea and vomiting
  • jaundice (yellowing of the skin and eyes)
  • abdominal cramps
  • enlarged liver
  • compromised function of the liver, kidneys, and lungs5

Non-cancerous side effects of Valsartan contaminated with NDMA include liver damage/disease and its attendant internal bleeding. Possible treatments for liver disease include:

  • good nutrition
  • abstaining from alcohol
  • corticosteroids
  • pentoxifylline
  • anabolic steroids
  • propylthiouracil
  • liver transplant

The most devastating potential consequence of NDMA exposure is developing cancer. Common cancers that may be caused by NDMA are:

  • liver cancer
  • pancreatic cancer
  • lung cancer
  • colorectal cancer
  • esophageal cancer
  • bowel cancer
  • stomach cancer6

Depending on the type of cancer, treatment may include brutal regimens of:

  • radiation
  • chemotherapy
  • surgery
  • targeted therapy

Currently, there is no routine lab test to determine the amount of NDMA in a person. But it can be detected in blood or urine.Note that there is also currently an emerging litigation of lawsuits over the drug Zantac, which too has been found to contain NDMA.

5. Alternatives to Valsartan

High-blood pressure patients who had been relying on currently recalled medications to regulate their hypertension have several other options. Patients should talk their doctor about the following alternative ARBs (angiotensin II receptor blockers): 

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People can avoid Valsartan NDMA risks by taking other types of blood pressure medications.
  • Azilsartan (Edarbi)
  • Candesartan (Atacand)
  • Eprosartan
  • Irbesartan (Avapro)
  • Losartan (Cozaar) (learn more about Valsartan versus Losartan)
  • Olmesartan (Benicar)
  • Telmisartan (Micardis)
  • brand-name Valsartan (Diovan)8

People who are currently taking Valsartan pills that have been recalled should stop taking them right away and consult their doctor. Even if they are not currently sick, NDMA can have a cumulative effect over time.

6. Suing for Valsartan injuries

People who have developed cancer after at least one (1) year of taking Valsartan contaminated with NDMA may be able to sue the pharmaceutical company for negligence and product liability. Depending on the case, plaintiffs may be able to recover the following compensatory damages:

  • medical bills (including costs for home health care)
  • pain and suffering
  • lost wages
  • loss of future wages

Most cases settle out of court. But if your Valsartan NDMA case goes to trial, we would also fight for high punitive damages to punish the pharmaceutical company for giving you cancer. It is common for punitive damages to far exceed compensatory damages.

Note that recently a Valsartan MDL (multi-district litigation) formed in the District of New Jersey. Thousands of lawsuits are expected to join it.

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If you developed cancer after having taken high blood pressure meds contaminated with NDMA, the personal injury attorneys at Shouse Law Group are here to help. We will do everything to thoroughly investigate your claim, aggressively negotiate with the pharmaceutical companies, and ruthlessly litigate your case in pursuit of the highest monetary damages possible.

You can reach our experienced and caring Valsartan NDMA attorneys anytime day or night at (855) 396-0370. You are entitled to a free consultation and case evaluation. Just be sure to act quickly before the Valsartan statute of limitations to file your lawsuit passes.


Legal References

  1. Regulations and Advisories, EPA.gov.
  2. Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA), EPA.gov.
  3. See Jacqueline Howard, "Valsartan recall: 4 things patients should know", CNN.com (November 1, 2018); Recalled Valsartan lots, FDA.gov.
  4. Statements, Novartis.com.
  5. Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA), EPA.gov.
  6. Muhammad Junaid Farrukh, Muhammad Haseeb Tariq, Obaidullah Malik, and Tahir Mehmood Khan, "Valsartan recall: global regulatory overview and future challenges", Ther Adv Drug Saf. 2019; 10: 2042098618823458.  (January 18, 2019).
  7. Public Health Statement for n-Nitrosodimethylamine, CDC.gov.
  8. Angiotensin II receptor blockers, Mayo Clinic.

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