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Valsartan is a widely-used prescription drug taken to treat hypertension and various 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 information immediately pushed the FDA and European health agencies to issue global 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 individuals 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 leading to 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 proved to be very effective not only for patients with high blood pressure but additionally people with congestive heart failure. In a study, Valsartan was compared with Captopril and another ACE inhibitor after a heart attack. The research determined that Valsartan was as effective as Captopril at keeping heart failure at bay.

An additional report determined Valsartan reduced the risk of heart failure by some 20 percent compared to a placebo group. The results led the FDA to approve a label change allowing Valsartan to be prescribed by doctors for patients with heart failure as well as hypertension.

Valsartan was initially developed by U.S. 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 being sold as a generic drug as

valsartan . After its launch, Valsartan rapidly established itself as one of the most widely used prescription medications in the world in the competitive blood pressure drug marketplace. In 2010, only four years after its launch, global revenue for the drug exceeded $6 billion. When the initial patent period for Valsartan expired in 2012 many other pharmaceutical companies began making generic variations of the drug. 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 makers of generic valsartan, the Chinese manufacturer Zhejiang Huahai Pharmaceuticals, initially discovered that the raw Valsartan it was manufacturing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical production laboratory which makes valsartan and sells it through U.S. channels Prinston, Huahi and Solco. The company synthesizes the Valsartan component and wholesales it to large pharmaceutical companies globally who then use it to make, package and sell their own generic versions of Valsartan. Zhejiang Huahai was by far the biggest 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 totally unexpected. The NDMA contamination was obviously possible from an alteration in the process of producing the drug that Zhejiang Huahai had adopted several years before.

The discovery created serious safety issues due to the known dangers of NDMA. NDMA is a well-known result of certain chemical manufacturing processes. NDMA is named as a carcinogen because it is known to cause cancer in humans. Many animal tests have established that exposure or ingestion of merely tiny amounts of NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys. In the past NDMA was used in the manufacture of rocket fuel, but this use was halted because of concerns regarding 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 immediately notified pharmaceutical companies and safety agencies. This prompted the U.S. Food and Drug Administration (FDA) and European health agencies to immediately recall all potentially contaminated versions of Valsartan. Since then, NDMA contamination has been observed in the valsartan components made by two other pharmaceutical suppliers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from these laboratories revealed lower amounts of NDMA in relation to the Zhejiang Huahai product.

The top manner to state how dangerous the problem with these contaminated medications is to show that there is wide support for continued investigation in Congress. These people can’t agree on the hue of the sky but are in agreement that they want more data on what happened with Valsartan.

Potential Harm from Contaminated Valsartan

NDMA is not only a particularly dangerous carcinogen, but it can additionally 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 just one occasion. In animal testing, taking high to moderate amounts of NDMA caused major liver damage after just a few days and cancer after just a few months.

An investigation into the cause of the NDMA contamination has shown that it was probably created by an alteration in the production process that Zhejiang Huahai began a few years ago. This means that Valsartan contaminated with NDMA was sold for many years before discovery and recall. This is very distressing because Valsartan is used as a maintenance medication which is taken daily on a long-term basis. This means that some users could have been ingesting NDMA once or twice a day for many years. This type of sustained long-term ingestion is exactly 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 might develop cancer from exposure to NDMA is very large.

What Valsartan Patients Need to Realize

If you have been taking Valsartan for treatment of hypertension or other conditions, you should immediately consult with your prescribing doctor about the possible dangers to your health. You should also find out what generic version of Valsartan you were receiving from your pharmacy. Not every generic versions of Valsartan were contaminated with NDMA, though the list continues to grow as the investigation proceeds. In the United States the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

How Much Money Can You Expect from a Valsartan Settlement?

Of course, affected people want to understand what the possible settlement value of the Valsartan case may be. It is a great question. The suffering victims might experience is extreme and money compensation is all we have to reach towards justice. The Valsartan lawsuits are just too recent to observe the potential settlement amount of these claims. We’ll learn more as the litigation progresses. A note to settlement value is to have lawyers who are going after 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.