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Valsartan is a widely-used prescription medication taken to control hypertension and other heart conditions. At the beginning of the year it was observed that some ingredients used to produce Valsartan were contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. This data immediately pushed the FDA and European health agencies to create global safety recalls of the tainted Valsartan products.

About Valsartan

Valsartan is an antihypertensive medication that is taken for controling high blood pressure as well as for people with congestive heart problems. It’s also prescribed to people with ventricle dysfunction after experiencing a heart attack. Valsartan works by effectively blocking angiotensin II – a peptide hormone that creates constriction of the blood vessels promoting higher blood pressure. This mechanism 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 established itself to be very effective not only for patients with high blood pressure but also patients with congestive heart failure. In a recent study, Valsartan was measured against Captopril and another ACE inhibitor after a heart attack. The research determined that Valsartan was as effective as Captopril in keeping heart failure minimized.

Another study found Valsartan minimized the risk of heart failure by approximately 20 percent measured against a placebo group. The results led the FDA to approve a label adjustment allowing Valsartan to be prescribed by physicians for patients with heart failure as well as hypertension.

Valsartan was originally created by American pharmaceutical giant Novartis and it was registered for use by the FDA in 1996. It was made available under the brand name Diovan prior to losing patent protection and then marketed as a generic medication as valsartan. After its release, Valsartan quickly established itself as one of the most widely used prescription medications globally in the competitive blood pressure drug marketplace. In 2010, only 4 years after its launch, global revenue for the medication surpassed $6 billion. When the original patent protection for Valsartan expired in 2012 a number of other pharmaceutical brands started to make generic versions of the medication. The biggest 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 manufacturers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, initially realized that the raw Valsartan it was producing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing laboratory which manufactures valsartan and sells it through U.S. channels Prinston, Huahi and Solco. The company synthesizes the Valsartan component then wholesales it to major pharmaceutical companies around the world who then use it to make, package and sell their own generic variations of Valsartan. Zhejiang Huahai was by far the biggest wholesale manufacturer of Valsartan component. During late June 2018, quality control tests at Zhejiang Huahai revealed that the batches of Valsartan it was producing were dangerously contaminated with N-nitrosodimethylamine (NMDA). The inclusion of NDMA was totally unexpected. The NDMA contamination was obviously caused by an alteration in the method of making the drug that Zhejiang Huahai had employed several years earlier.

The discovery raised serious safety issues because of the known risks from NDMA. NDMA is a well-known byproduct of certain chemical manufacturing procedurs. NDMA is classified as a carcinogen because it is known to cause cancer in humans. Numerous animal studies have proven that exposure or ingestion of merely small amounts of NDMA may cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the production of rocket fuel, but this use was stopped because of issues about environmental contamination. The EPA regards NDMA as a probable human carcinogen. NDMA is identified as a priority toxic pollutant in federal regulations.

After realizing the NDMA contamination, Zhejiang Huahai promptly alerted pharmaceutical companies and safety agencies. This prompted the U.S. Food and Drug Administration (FDA) and European health officials to immediately recall any possibly contaminated versions of Valsartan. Since then, NDMA contamination has been observed in the valsartan components produced by two other pharmaceutical wholesalers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from those labs revealed lower amounts of NDMA in relation to the Zhejiang Huahai product.

The most effective way to state how serious the problem with these contaminated medications is to point out that there is wide support for further investigation in Congress. Congress can’t agree on the hue of the sky but they agree that they need more information on what occurred with Valsartan.

Possible Harm from Contaminated Valsartan

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

An investigation about the cause of the NDMA contamination has revealed that it was most likely created by an alteration in the manufacturing method that Zhejiang Huahai started a few years ago. This means that Valsartan tainted with NDMA was on the market for many years before realization and recall. This is very disturbing because Valsartan is used as a maintenance medication which is taken daily on a continuing basis. This means that some people may have been taking NDMA once or twice a day for several years. This sort of continuous long-term use is specifically the kind of exposure that might cause cancer. NDMA exposure is linked to specific cancers like:

Liver Cancer

Gastric Cancer

Colorectal Cancer

Kidney Cancer

Given the widespread ingestion of Valsartan, the amount of people who may suffer from cancer from exposure to NDMA is extremely large.

What Valsartan Patients Need to Realize

If you have been taking Valsartan for treatment of hypertension or other conditions, you can immediately consult 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 all generic versions of Valsartan were contaminated with NDMA, although the list keeps growing as the research proceeds. In the U.S. the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

What Amount of Money Can You Anticipate from a Valsartan Settlement?

Understandably, affected people would like to understand what the possible settlement amount of the Valsartan case may be. It is a great question. The suffering users may experience is significant and money compensation is all we have to reach towards justice.

valsartan cancer are just too new to observe the possible settlement value of these claims. We will learn more as the litigation progresses. A key to settlement amount is to have lawyers who are fighting for every possible dollar and are fighting to maximize the value of your case for everything that you have had to live with either as a victim or surviving family member.