Valsartan Recalls and Your Risk of Developing Cancer

Valsartan is a common ingredient in prescription medications used to treat heart failure and high blood pressure. Over the past three months, multiple pharmaceutical suppliers have recalled batches of the drugs due to possible contamination by a potential carcinogen.

New information has come to light about the potential risk that patients might face if they took the contaminated drugs for any length of time, including an elevated risk of developing certain cancers.

A quick timeline of the recalls

On July 13, 2018, the Food & Drug Administration (FDA) issued a voluntary recall of the drug when certain batches were found to contain N-nitrosodimethylamine (NDMA), an impurity “classified as a probable human carcinogen.” The batches in question were produced by Zhejiang Huahai Pharmaceuticals in Linhai, China.

On August 9, 2018, the FDA updated the list of contaminated batches to include those produced by Hetero Labs Limited in India and labeled as “Camber Pharmaceuticals, Inc.” By this time, the list of recalled products had been updated twice, adding a number of other manufacturers to the list.

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is why we’ve asked these companies to take immediate action to protect patients.”

On August 20, 2018, Torrent Pharmaceuticals Limited recalled “14 lots of valsartan/ amlodipine/ hydrochlorothiazide (HCTZ) tablets.” The company updated its list on August 22^nd and August 24^th.

Carcinogenic NDMA and its connection to other potential injuries

NDMA is an organic chemical – a naturally occurring waste product of certain types of industrial and natural processes, according to the Environmental Protection Agency (EPA). Because it mixes easily with water, it can contaminate groundwater, which affects the soil as well.

The EPA recognizes NDMA as a “priority pollutant,” and the product is classified as a Group B2, which means it is a “probable human carcinogen.” The World Health Organization claims NDMA is “clearly carcinogenic,” per PBS, “due to its ability to cause stomach and colon cancer after ingestion.” An earlier study published in The American Journal of Clinical Nutrition found that “There was an overall increased cancer risk with NDMA when cancers of the gastrointestinal tract were analyzed as combined,” including rectal cancer, pancreatic cancers, kidney cancers, skin cancers and bladder cancers.

According to EPA research, “N-Nitrosodimethylamine has been found to be carcinogenic in a number of animal species, inducing tumors in various organs and by various routes of exposure. Increased incidences of liver, kidney, and lung tumors have been observed in rats and mice that inhaled N nitrosodimethylamine. Liver tumors have also been observed in orally exposed rats, mice and hamsters.”

NDMA may also cause non-cancerous injuries, such as liver damage — including hemorrhagic necrosis, a form of tissue death caused by excessive bleeding within in the liver – as well as jaundice and low platelet counts.

What scientists say about the cancer risk from taking valsartan drugs

In September 2018, the medical journal The BMJ published the results of a study to review the potential short-terms risks of developing cancer after taking contaminated valsartan. The study reviewed medical records of more than 5,100 patients (all of whom were at least 40 years-old) who took valsartan drugs between January 1, 2012 and June 20, 2018. None of the patients had any prior history of cancer when they started taking the medication.

Per the author, the study “provides reassuring interim evidence about the risk of cancer in patients treated with valsartan products contaminated with a probable human carcinogen.”

The author goes on to say, however, that “this study alone cannot dispel doubts about the potential risk for patients in the longer term.”

According to a piece in Science Daily, “exposure to potentially NDMA contaminated valsartan products showed no association with cancer compared with exposure to valsartan products that were not contaminated with NDMA…. However, when [researchers] analysed single cancers, they found a slightly increased (but not statistically significant) risk of colorectal cancer and uterine cancer in patients exposed to NDMA.”

I took valsartan. Am I at risk of developing cancer?

First, you should know that not all valsartan drugs were contaminated. Because the study only looked at the short-term risks, there was no evidence of a long-term cancer risk.

NDMA has been linked to multiple cancers in rats and other lab animals, and has been found to cause multiple types of cancers in humans, but at this time, the primary cancers linked to patients who took contaminated valsartan drugs are colorectal cancer and uterine cancer.

In the short-term, however, the risk is real but low: approximately 9%, which researchers deemed “negligible and statistically non-significant.” As Dr. Erin Michos of Johns Hopkins University’s School of Medicine told CNN that more research is needed over a longer period of time to evaluate the cancer risk associated with the drugs.

“It provides some modest reassurance for the short-term,” she said. “There hasn’t been long enough follow-up to really see a 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.’”

Claiming compensation for a defective drug

Nine percent may be “statistically non-significant” to scientific researchers, but it won’t feel that way to a person who develops cancer as a result of taking a contaminated valsartan drug.

Harris Lowry Manton LLP has helped people throughout Georgia who have been injured or killed by dangerous drugs. We have secured millions of dollars on behalf of clients who filed product liability claims, and we have the resources to handle the complex litigation that often goes along with these claims.

If you developed cancer after taking a valsartan medication and you believe it may be linked to carcinogenic impurities in the drug, we want to hear from you. Our experienced medical products liability lawyers in Atlanta and Savannah can fight on your behalf. Please call our Atlanta team at 404-961-7650, our Savannah team at 912-651-9967, or fill out our contact form to schedule a free consultation.