Valsartan is a popular prescription medication taken to treat hypertension and various heart conditions. At the beginning of the year it was discovered that some ingredients used to make Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to create cancer in humans. This information immediately motivated the FDA and European health agencies to issue global safety recalls of the contaminated Valsartan products.

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Valsartan is an antihypertensive drug that is taken for the treatment of high blood pressure as well as for people with congestive heart problems. It is also prescribed to individuals 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 promoting higher blood pressure. This functionality made Valsartan more efficient than similar drugs before it that only worked by blocked the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).

Valsartan proved to be very effective not only for people 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 study found that Valsartan was as effective as Captopril in keeping heart failure minimized.

An additional study found Valsartan reduced the risk of heart failure by some twenty percent measured against a placebo group. These results led the FDA to approve a label change allowing Valsartan to be used by doctors for people with heart failure in addition to hypertension.

Valsartan was initially developed by U.S. pharmaceutical corporation Novartis and it was registered for use by the FDA in 1996. It was marketed under the brand name Diovan before losing patent protection and then marketed as a generic medication as valsartan. Following its release, Valsartan quickly became one of the most frequently taken prescription drugs globally in the competitive blood pressure medication marketplace. In 2010, only four years after its launch, global revenue for the drug exceeded $6 billion. When the original patent period for Valsartan expired in 2012 a number of other pharmaceutical companies began making generic variations of the drug. The largest generic manufacturers of Valsartan were Teva Pharmaceuticals Industries Ltd. and Solco Healthcare Inc.

Contamination of Valsartan with NDMA

In 2018, one of the leading manufacturers of generic valsartan, the Chinese manufacturer Zhejiang Huahai Pharmaceuticals, initially discovered that the raw Valsartan it was making was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing lab that makes valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company synthesizes the Valsartan compound and distributes it to major pharmaceutical companies around the world who then use it to manufacture, package and sell their own generic variations of Valsartan. Zhejiang Huahai was by far the biggest wholesale producer of Valsartan component. Sometime in late June 2018, quality control tests at Zhejiang Huahai determined that the batches of Valsartan it was manufacturing were dangerously contaminated with N-nitrosodimethylamine (NMDA). The appearance of NDMA was entirely unexpected. The NDMA contamination was obviously possible from a change in the method of synthesizing the medication that Zhejiang Huahai had chosen many years before.

The discovery created significant safety issues due to the known dangers of NDMA. NDMA is a well-known leftover of certain chemical making processes. NDMA is reported as a carcinogen because it is known to cause cancer in humans. Numerous animal tests have determined that exposure or ingestion of even tiny amounts of NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the making of rocket fuel, but this use was stopped because of issues regarding environmental contamination. The EPA classifies NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.

After discovering the NDMA contamination, Zhejiang Huahai immediately alerted pharmaceutical companies and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health officials to immediately recall all possibly affected versions of Valsartan. Since then, NDMA contamination has been discovered in the valsartan components produced by 2 other pharmaceutical wholesalers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from these labs revealed lower levels of NDMA in relation to the Zhejiang Huahai product.

The top manner to highlight how serious the issue with these tainted drugs is to point out that there is wide support for further investigation in Congress. Congress cannot agree on the color of the sky but they agree that they want additional information on what happened with Valsartan.

Potential Injuries from Tainted Valsartan

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

An investigation about the cause of the NDMA contamination has revealed that it was probably caused by a change in the manufacturing method that Zhejiang Huahai started several years ago. This means that Valsartan contaminated with NDMA was on the market for many years prior to discovery and recall. This is highly disturbing because Valsartan is used as a maintenance medication which is taken daily on a continuing manner. This means that some people may have been ingesting NDMA once or twice a day for many years. This sort of sustained long-term use is specifically the kind of exposure that may cause cancer. NDMA exposure is related to specific cancers like:

Liver Cancer

Gastric Cancer

Colorectal Cancer

Kidney Cancer

Given the widespread use of Valsartan, the amount of people who could develop cancer from exposure to NDMA is very large.

What Valsartan Users Should to Know

If you have been taking Valsartan for treatment of hypertension or other issues, you should immediately meet with your prescribing doctor about the potential dangers to your wellness. You should also find out what generic version of Valsartan you were receiving from your pharmacy. Not every generic versions of Valsartan were tainted with NDMA, although the list continues to grow as the research continues. In the United States the safety recall only applied to the Valsartan made by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

What Amount of Money May You Expect from a Valsartan Settlement?

Understandably, people want to understand what the possible settlement amount of the Valsartan case might be. It’s a good question. The suffering victims may endure is extreme and money compensation is all we have to reach to justice. The Valsartan lawsuits are simply too recent to observe the potential settlement value of these claims. We’ll learn more as the litigation continues. One note to settlement amount is to have lawyers who are fighting for every potential dollar and are determined to maximize the amount of your case for all that you have had to endure either as a victim or surviving family member.