A carcinogen is a substance capable of causing cancer in a living thing.
In 2018, the U.S. Food and Drug Administration (FDA) identified multiple carcinogens in several generic blood pressure medications. Manufacturers then recalled more than 600 lots of valsartan medications. Patients are now concerned with the link between generic valsartan and cancer.
Contaminants in Valsartan
Two probable human carcinogens have been identified in valsartan medications. These impurities are known as N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).
NDMA prompted the first of the recalls in July 2018. With the exception of scientific research, NDMA is not currently produced in the United States. Previously, people used NDMA in manufacturing. Most notably, it was used in the production of rocket fuel.
NDMA is classified as a probable human carcinogen by two organizations:
- The U.S. Environmental Protection Agency (EPA)
- The International Agency for Research on Cancer (IARC)
They base this classification on tumor growth recorded in animal studies. Exposure to NDMA in large quantities may also cause severe physical symptoms. These symptoms can include vomiting, headaches, dizziness, fever, nausea, jaundice and liver damage.
NDEA is a synthetic oil sometimes added to gasoline and lubricants.
The EPA and IARC classify NDEA as a probable human carcinogen based on the results of animal studies.
Does Valsartan Cause Cancer?
Many patients are worried about the valsartan-cancer link. It's important these patients understand two main facts about the valsartan contaminations.
- Patients can only develop cancer from valsartan medication that is contaminated. The probable human carcinogens found in recalled valsartan may cause cancer. The drug itself does not.
- The recall did not include all valsartan products or manufacturers. For example, the brand name valsartan drug, Diovan, was not recalled.
The Estimated Valsartan Cancer Risk
The FDA estimated the potential cancer risk for patients taking recalled valsartan. The agency based the estimate on a hypothetical scenario. All estimates are based on hypothetical patients taking the highest dose of contaminated valsartan for a period of four years.
According to the analysis, the risk is relatively low. For every 8,000 patients in this situation, the agency estimated one additional cancer diagnosis. This is likely an overestimate of the actual risk, as most patients have already stopped taking the contaminated valsartan.
The FDA estimated an even lower potential risk for patients taking valsartan with NDEA. Again, the agency looked at the risk for patients taking the highest dose of the drug throughout a four-year period. Out of 18,000 people, the FDA estimated one additional case of cancer. The agency found smaller trace amounts of NDEA in the recalled blood pressure drugs. This may explain the lower relative risk of cancer for NDEA-contaminated lots.
In August 2019, the FDA released a follow-up statement about the agency's estimations. The statement stresses the estimations reflect a scenario involving the highest exposure level. The highest exposure level is defined by FDA-cleared indications for the drugs. The actual risk to a patient will likely be lower.
Types of Cancer Caused By Contaminated Valsartan
Despite the FDA's low estimates, recent research suggests exposure to NDMA could lead to the following cancers:
- Colorectal cancer
- Uterine cancer
Valsartan and Cancer Study Data
Two months after the first voluntary recall, a Danish cohort study was published. The study examined the potential cancer risk from valsartan contaminated with NDMA. The research team used national medical registries and databases to conduct the study.
The team analyzed the medical information of more than 5,000 study participants. These participants all met the following criteria:
- The study participants had no history of cancer, except for non-melanoma skin cancer.
- The study participants were more than 39 years of age.
- The study participants were taking valsartan at the start of January 2012 or began taking it between January 1, 2012, and June 30, 2017.
Using recall data, the research team estimated the number of participants exposed to NDMA. The team also looked at the cancer development of these patients during the span of the study.
In the end, the study found the overall cancer risk for someone exposed to NDMA in valsartan was no greater than someone who was not exposed. However, the study reached a different conclusion for individual cancers.
According to study data, people exposed to NDMA have a 46% higher risk of colorectal cancer. They have an 81% higher risk for uterine cancer as well. The researchers indicated their results may not be conclusive and called for further studies.
What to Do if You're Taking a Recalled Valsartan Medication
- Don't stop taking the recalled drug. Valsartan treats serious health conditions. It is unsafe for patients to stop using the drug without starting another treatment method.
- Talk to your doctor. Your doctor can help you understand the risks of the recalled medication. They can also prescribe a replacement medication or an alternative treatment option.
- Consider legal action. Following the recalls, hundreds of consumers filed lawsuits against the drug's manufacturers. If you want to learn more about the lawsuits filed and how you can be apart of them, visit our valsartan lawsuit page.
You may also want to speak with your local pharmacist or call the drug's manufacturer. They can help you determine the best method of disposal for the recalled medication. In some cases, you may be eligible for a refund as well. Contact your prescription manufacturer for a refund or return information.