Valsartan is a commonly prescribed drug for high blood pressure and heart failure. The FDA announced a recall of Valsartan made in China and contaminated with a carcinogen (cancer-causing substance) called N-nitrosodimethylamine (NDMA).
NDMA is known to cause cancer in animals and is suspected to cause cancer in humans. A study in Denmark showed a 9% cancer risk increase in patients who took Valsartan contaminated with NDMA. Anyone who was prescribed Valsartan can check the FDA recall list to find out if their Valsartan is contaminated. Valsartan is now the subject of numerous lawsuits claiming this contamination has caused liver damage and cancer.
In this article, our personal injury lawyers will address:
- 1. What is Valsartan?
- 2. Does Valsartan cause cancer?
- 3. What kind of cancer can contaminated Valsartan cause?
1. What is Valsartan?
Valsartan is a drug prescribed for high blood pressure and heart failure. The FDA announced a recall of certain products containing Valsartan manufactured by Chinese drug company Zhejiang Huahai Pharmaceutical Co. (ZHP), because authorities found that a carcinogen called N-nitrosodimethylamine (NDMA) was in the drugs. Countries around the world have recalled contaminated Valsartan. After the recall, researchers did a study that showed a 9% increase in cancer risk in patients in Denmark who took contaminated Valsartan.
Valsartan is the generic version of the drug Diovan. Generic drugs are supposed to be “bioequivalent” to their brand-name counterparts, which means they are supposed to be of equal quality and safety. NDMA is not approved as an ingredient in Valsartan or Diovan, and the amount of NDMA found in Valsartan also exceeded regulatory exposure limits where applicable. NDMA may have contaminated some batches of Valsartan made by ZHP since 2012, due to ZHP’s manufacturing process.
The FDA found a second carcinogen, N-nitrosodiethylamine (NDEA), in some batches of Valsartan that were also contaminated with the first carcinogen. NDEA causes cancer in animals and is also “reasonably anticipated” to cause cancer in humans.
The FDA has banned further imports of drugs made by ZHP. Some patients have filed lawsuits against Valsartan drugmakers and pharmacies that sold the contaminated drugs.
2. Does Valsartan cause cancer?
The chemicals NDMA and NDEA that contaminated some Valsartan drugs have been shown to cause cancer in animals and are expected to cause cancer in humans.
A study published in September 2018 shows a 9% increase in cancer risk in patients in Denmark who took Valsartan contaminated with NDMA. Some important highlights from the study are:
- Researchers saw an increased risk for colorectal cancer and uterine cancer in particular.
- Some foods such as processed meat contain small amounts of NDMA. Researchers who studied data on what foods people eat found an increased risk of gastrointestinal cancer with exposure to NDMA, mainly colorectal cancer.
- NDMA is one of the strongest carcinogens in animals, in single doses and in smaller doses over periods of time.
- The International Agency for Research on Cancer classifies NDMA as “probably carcinogenic to humans” and believes that NDMA “should be regarded for practical purposes as if it were carcinogenic to humans.”
- The daily exposure in humans from taking contaminated Valsartan is roughly 30 times lower than the lowest dose leading to liver cancer in rats.
- The exposure to humans from taking contaminated Valsartan is higher than regulations allow.
- Recent prescriptions might contain more NDMA, because patients who started taking Valsartan later in the study had a higher increased risk of cancer than patients who started taking Valsartan at the beginning of the study.
The authors of the Danish study emphasized that longer-term studies should be done too. Another doctor who did not work on the study also pointed out that sometimes cancer can take time to show up, so we don’t know how many people who took contaminated NDMA will get cancer, even if they don’t have it yet.
Before the 2018 study, authorities already knew many harmful effects of NDMA and NDEA. For example:
- The US Environmental Protection Agency (EPA) classifies NDMA as a “probable human carcinogen” and as a “confirmed animal carcinogen.”
- The World Health Organization lists NDMA as “probably carcinogenic to humans,” and states that it may be released as a byproduct from municipal wastewater treatment facilities and some industrial manufacturing facilities.
- The FDA is part of the US Department of Health and Human Services, which says NDMA is “reasonably anticipated” to cause cancer in humans.
- The State of California considers NDMA and NDEA to be carcinogens and cites the National Toxicology Program as recognizing them as “reasonably anticipated to be human carcinogens.”
- Scientists sometimes use NDMA and NDEA to cause cancer in laboratory animals on purpose, for research.
- People have used NDMA as a poison in murders.
Contaminated Valsartan poses cancer risks. Valsartan that has not been contaminated is not thought to cause cancer. Click here for FDA updates about Valsartan, and click here for the list of Valsartan products that the FDA has recalled.
3. What kind of cancer can contaminated Valsartan cause?
A 2018 Danish study showed that NDMA-contaminated Valsartan can increase the risk of cancer of the liver, stomach, colon, rectum, and pancreas. Colorectal and uterine cancer were the types of cancer particularly linked to contaminated Valsartan. Researchers will need to do longer-term studies as well, to see if contaminated Valsartan may cause other kinds of cancer too.
Animal studies have associated NDMA with the following types of cancer:
- Colorectal cancer
- Gastric cancer
- Liver cancer
- Kidney cancer.
Contaminated Valsartan can put patients at risk of cancers of the gastrointestinal tract, liver, and uterus, or of other organs. Contaminated Valsartan is also known to cause liver damage.
Learn more about Valsartan injuries, complications, and side effects.