Valsartan is a popular prescription drug used to treat hypertension and other heart conditions. Earlier this year it was discovered that some ingredients used to produce Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to create cancer in humans. This information immediately pushed the FDA and European health officials to submit worldwide safety recalls of the contaminated Valsartan products.

About Valsartan

Valsartan is an antihypertensive drug that is taken for controling high blood pressure as well as for people with congestive heart problems. It is also prescribed to patients with ventricle dysfunction after suffering a heart attack. Valsartan works by effectively blocking angiotensin II – a peptide hormone that causes constriction of the blood vessels leading to higher blood pressure. The mechanism made Valsartan more efficient than similar drugs before it that merely worked by stopping the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).

Valsartan established itself to be very effective not only for patients with high blood pressure but additionally patients with congestive heart failure. In one study, Valsartan was compared with Captopril and another ACE inhibitor after a heart attack. The research found that Valsartan was as effective as Captopril at keeping heart failure at bay.

Another report determined Valsartan reduced the risk of heart failure by approximately twenty percent compared to a placebo group. These results led the FDA to approve a label adjustment allowing Valsartan to be prescribed by physicians for people with heart failure in addition to hypertension.

Valsartan was initially developed by U.S. pharmaceutical giant Novartis and it was registered for use by the FDA in 1996. It was sold under the brand name Diovan before losing patent protection and being sold as a generic medication as valsartan. After its launch, Valsartan quickly established itself as one of the most widely used prescription drugs in the world in the competitive blood pressure drug marketplace. In 2010, only 4 years after its release, global revenue for the drug surpassed $6 billion. When the original patent protection for Valsartan expired in 2012 many other pharmaceutical corporations began making generic versions of the drug. The largest generic manufacturers of Valsartan were Teva Pharmaceuticals Industries Ltd. and Solco Healthcare Inc.

Contamination of Valsartan with NDMA

In July 2018, one of the leading makers of generic valsartan, the Chinese manufacturer Zhejiang Huahai Pharmaceuticals, first realized that the raw Valsartan it was manufacturing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing laboratory that makes valsartan and sells it through U.S. affiliates Prinston, Huahi and Solco. The company synthesizes the Valsartan compound then distributes it to major pharmaceutical companies globally who then use it to manufacture, package and market their own generic versions of Valsartan. Zhejiang Huahai was by far the largest wholesale manufacturer of Valsartan compound. Sometime in late June 2018, quality control tests at Zhejiang Huahai determined that the batches of Valsartan it was producing were dangerously contaminated with N-nitrosodimethylamine (NMDA). The inclusion of NDMA was entirely unexpected. The NDMA contamination was obviously possible from a change in the process of synthesizing the medication that Zhejiang Huahai had adopted many years before.

The discovery raised significant safety concerns because of the known dangers of NDMA. NDMA is a well-known result of certain chemical manufacturing processes. NDMA is reported as a carcinogen because it is known to cause cancer in humans. Numerous animal tests have proven that exposure or ingestion of merely small amounts of NDMA might cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the manufacturing of rocket fuel, but this use was stopped because of concerns regarding environmental contamination. The EPA regards NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.

After discovering the NDMA contamination, Zhejiang Huahai promptly notified pharmaceutical brands and safety agencies. This prompted the U.S. Food and Drug Administration (FDA) and European health agencies to immediately recall all possibly affected versions of Valsartan. Since then, NDMA contamination has been found in the valsartan components produced by two other pharmaceutical suppliers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from those laboratories revealed lower amounts of NDMA compared to the Zhejiang Huahai product.

The most effective manner to show how dangerous the problem with these contaminated medications is to point out that there is bipartisan support for continued investigation in Congress. These people cannot agree on the color of the sky but are in agreement that they need more information on what happened with Valsartan.

Potential Harm from Contaminated Valsartan

NDMA is not only a very dangerous carcinogen, but it might also be a poison at high levels. There have been several reported cases in which people died from internal bleeding and significant liver damage after taking high doses of NDMA on merely one occasion. In animal testing, taking high to moderate amounts of NDMA caused significant liver damage after just a few days and cancer after just several weeks.

An investigation about the cause of the NDMA contamination has shown that it was probably caused by an alteration in the production process that Zhejiang Huahai started several years ago. This means that Valsartan tainted with NDMA was on the market for several years prior to realization and recall. This is highly disturbing because Valsartan is used as a maintenance drug which is ingested daily on a continuing basis. This means that some patients may have been taking NDMA once or twice a day for several years. This kind of sustained long-term ingestion is exactly the type of exposure that can cause cancer. NDMA exposure is linked to specific cancers such as:

Liver Cancer

Gastric Cancer

Colorectal Cancer

Kidney Cancer

Given the widespread ingestion of Valsartan, the number of people who might suffer from cancer from exposure to NDMA is very large.

What Valsartan Patients Need to Know

If you’ve been taking Valsartan for treatment of hypertension or other issues, you can immediately meet with your prescribing doctor regarding the possible dangers to your wellness. You should also find out what generic version of Valsartan you were receiving from your pharmacy. Not all generic versions of Valsartan were contaminated with NDMA, although the list keeps growing as the research continues. In the U.S. the safety recall only applied to the Valsartan made by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

What Amount of Money Might You Anticipate from a valsartan stomach cancer Settlement?

Of course, patients would like to understand what the possible settlement value of the Valsartan case could be. It is a great question. The suffering victims could endure is extreme and money compensation is all we have to reach towards justice. The Valsartan lawsuits are just too new to observe the possible settlement value of these claims. We will understand more as the litigation continues. A key to settlement amount is to have lawyers that are fighting for every potential penny and are determined to maximize the value of your case for all that you have had to endure either as a victim or surviving family member.