Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs) and is used to treat high blood pressure and heart failure. But more recently, valsartan has been linked to a contamination. While valsartan has not been confirmed as a cause of stomach cancer, studies have linked the disease to NDMA – a recent valsartan contaminant.

Why is Valsartan Being Recalled?

In July 2018, the U.S. Food and Drug Administration (FDA) announced the voluntary recall of several valsartan medications. The reason behind the recall was reported contamination with a probable carcinogen – N-Nitrosodimethylamine (NDMA).

NDMA is an environmental contaminant that is most commonly found in water or foods such as meats, dairy products, and vegetables. However, the impurity may also be generated during certain manufacturing processes when creating pharmaceutical active ingredients. According to the FDA, this occurred during the manufacturing of valsartan’s active ingredient.

Since the initial recall, further manufacturers have recalled additional lots of valsartan. The recall has also been expanded to include other angiotensin II receptor blockers (ARBs) such as losartan and irbesartan. Valsartan combination drugs may also be included in the lot.

The FDA notes that patients shouldn’t stop taking their medication due to concerns of contamination. Although there are numerous manufacturers and lots affected by the recall, not all ARBs are being recalled and not all lots of valsartan are affected.

Instead of stopping the medication without consulting a doctor, the FDA recommends that patients check the ARB recall list available on their website to see if their medication is affected. If it is, patients are directed to contact their pharmacist to get an uncontaminated lot of valsartan. If this is not an option for certain patients, the FDA recommends contacting their doctor to find another treatment option.

What are Drug Manufacturers Doing To Protect Consumers?

Though recalls are important in protecting consumers and holding drug companies accountable for what they produce, recalls are expensive and inconvenient to implement. Additionally, they can possibly disrupt the the drugs that are available to consumers, which can pose health risks to those who rely on the medications.

Technology Networks explains that the possible presence of NDMA in valsartan and another high blood pressure medication, Zantac, has led experts to examine novel ways to test for impurities. In particular, manufacturers are experiencing increased demand to conduct more rigorous testing for NDMA, to better determine if the contaminant could be present.

Standard testing methods are those which are reviewed in routine inspection, adding to the difficulty of discovering NDMA in medications. According to Technology Networks, NDMA and related chemicals are particularly difficult to detect with standard testing methods. Happily, new technologies for testing are appearing to be fast and fairly accurate.

Technology Networks also notes that these new testing methods that give accurate insight into how NDMA forms and contaminates a medication are particularly important to certain manufacturers. Without these new testing methods, manufacturers who do not otherwise produce NDMA might not know how to recognize it if it appears in their drugs.

Technology Networks explains that it is important to be able to test for impurities during the manufacturing process, as opposed to after the drugs have been produced. Testing is less impactful after the drugs have reached consumers because they could have already caused harm to the public, possibly setting them up for a risk of stomach cancer or other ailments.

Was Brand Name Diovan Part of the Recall?

No. The recall only affected certain generic versions of valsartan, not the Diovan name brand drug.

The FDA became aware of valsartan contamination when the active pharmaceutical ingredient (API) from a lab in China was found to be tainted with NDMA in the summer of 2018. Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP) had some valsartan test positive for NDMA, and the FDA placed an import alert to stop all of the facility’s API and finished medications made using the facility’s API from legally entering the U.S.

It wasn’t long before other manufacturers of valsartan’s API began showing positive test results for NDMA, and some for NDEA, too. Solco Healthcare LLC, a subsidiary of Prinston Pharmaceutical Inc., had to recall contaminated API due to tests that found unacceptable levels of NDEA.

Similar to NDMA, NDEA is another impurity that can cause human harm at very low levels, according to the FDA. Both impurities are genotoxic, which means they damage DNA at the cellular level, creating mutations that can include cancer.

“Our investigation into ZHP’s process identified that a change made to the manufacturing process likely led to this impurity, and that the impurity went undetected by global regulators, including the FDA, for a period of time,” admits the FDA in a statement on its website.

The FDA also notes that while all humans should limit their exposure to genotoxic impurities, NDMA and NDEA are found in many charcoal-grilled foods. The government regulator also notes that their goal is for people to keep their ingestion of such impurities as low as possible.

Does Valsartan Cause Stomach Cancer?

The FDA reports that the risk of getting cancer after taking a contaminated drug is very small. According to Web MD, the agency has predicted that there would be only one additional case of cancer over the lives of 8,000 people if each of these patients took the highest valsartan dose from contaminated batches every day for four years.

Although the FDA has said that the risk is fairly low, some consumers are still concerned about their risk of cancer after unknowingly taking contaminated valsartan.

So far, scientific studies have not confirmed valsartan as a cause of stomach cancer. However, NDMA – the valsartan contaminant – has been concluded to be a potential cause of the gastric disease.

In 2016, researchers from the Chinese Center for Disease Control and Prevention examined the relationship between NDMA and digestive cancers. The results showed that NDMA caused a “significant increase” in the risk for digestive tract cancers, including gastric cancer.

Although a formal link hasn’t been established in studies, valsartan manufacturers have already faced legal action from consumers who claim that the drug caused stomach cancer, leading to pain and suffering and other damages.

In March 2019, plaintiff Kevork A. filed a valsartan lawsuit against several pharmaceutical companies. He claimed that, as a result of taking a valsartan generic drug from October 2015 and June 2018, he developed gastric cancer. He was reportedly diagnosed with the disease in May 2018 and has allegedly been left with “permanent and disabling injuries.”

The Valsartan Contamination Lawsuit is Case No. 1:19-cv-06822, in the U.S. District Court for the Eastern District of California.