A valsartan recall was issued by the U.S. Food and Drug Administration (FDA) earlier this month because a potential cancer-causing substance was found in the product.

Patients with high blood pressure and heart failure are apt to be prescribed valsartan, an angiotensin II receptor that prevents blood vessels from narrowing. Unrestricted blood vessels enable blood pressure to lower and increases circulation.

Valsartan is the generic version of Diovan, which is made by Novartis International AG. Diovan and several generic versions made by companies other than the ones listed below are not part of the valsartan medication recall.

The valsartan recall includes the generic medication made by:

• Major pharmaceuticals
• Solco Healthcare
• Teva Pharmaceuticals Industries Ltd.

Valsartan/hydrochlorothiazide combination medications made by both Solco and Teva also are covered by this valsartan recall. The hydrochlorothiazide is a diuretic.

Valsartan Recall Due to Contamination

The affected medications were found to be tainted with an impurity known as N-nitrosodimethylamine (NDMA). The medication itself is not the problem, but the contaminated lots can cause serious side effects. Valsartan tainted with NDMA could place patients at a greater risk for cancer.

The European Medicines Agency reported in May 2018 that a possibly dangerous impurity had been detected in valsartan made at Chinese pharmaceutical manufacturing company Zhejiang Huahai Pharmaceuticals. Further inspection determined the substance was NDMA, which is considered “a probable human carcinogen” by the U.S. Environmental Protection Agency (EPA).

A statement released by the FDA said “the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”

Based on Zhejiang’s own records, the NDMA contamination could go back several years because the changes made at the company’s manufacturing facility that led to the introduction of NDMA in the valsartan allegedly were completed in 2012.

According to the EPA, NDMA is a yellow liquid with little odor and a sweet taste. NDMA was previously used in the production of rocket fuel and antioxidants.

NDMA also has been detected as an unintended byproduct when waste water treatment plants use chloramines to disinfect the water. Over the years, concerns have existed that NDMA could contaminate drinking water and that it could leach into groundwater from the soil.

The FDA released a statement that the agency is working to make sure valsartan patients in the U.S. have an “adequate supply of unaffected medications.”

What is the Connection Between Valsartan and Cancer?

NDMA, the substance found inside contaminated valsartan, has been shown to increase the risk of cancer in patients by as much as 9%, according to a study in Denmark. Currently, NDMA is believed to cause cancer in humans and is known to cause cancer in animals. The animal cancer risk is very powerful in smaller doses over a long period of time and in single doses.

That same study from Denmark also found that the biggest risk was connected to uterine and colorectal cancer.  Other kinds of cancer named in the study include those affecting the stomach, liver, and pancreas.

Can Valsartan Contamination Increase Short-Term Cancer Risk?

A new study has found that there’s no significant increase in the short-term cancer risk for people who took valsartan contaminated with NDMA. However, this is only one limited study and the researchers remarked that further studies should be completed.

The relative risk for people who use this medication contaminated with NDMA is low, according to the FDA. As reported by Healthline, scientists at that agency estimated that if 8,000 people used the highest available dose of valsartan over the course of four years, then there might be just one additional cancer case over the life of those people.

This is an estimate, though, and the side effects and risks associated with cancer can be severe. Not enough research has been completed to fully review the possibility of developing cancer in the future due to contaminated NDMA. Patients who think they might be impacted due to previous use of contaminated valsartan should monitor their health closely.

Patients who have been taking medications affected by the valsartan recall and have been diagnosed with cancer might not link the drug to their ailments simply because the cancer is not a side effect of the drug itself, but of the contaminant NDMA.

If you have been diagnosed with cancer after taking valsartan, you could be eligible for compensation through legal means.