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Valsartan is a popular prescription drug taken to control hypertension and various heart issues. At the beginning of the year it was observed that certain ingredients used to produce Valsartan were contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. This data immediately prompted the FDA and European health officials to submit global safety recalls of the tainted Valsartan products.

About Valsartan

Valsartan is an antihypertensive medication that is taken for controling high blood pressure and for people with congestive heart issues. 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. The mechanism made Valsartan more efficient than similar medications before it that only worked by stopping the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).

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

Another report found Valsartan minimized the risk of heart failure by approximately twenty percent measured against a placebo group. The results motivated the FDA to approve a label adjustment allowing Valsartan to be prescribed by doctors for patients with heart failure in addition to hypertension.

Valsartan was initially created by American pharmaceutical corporation Novartis and it was approved for use by the FDA in 1996. It was made available under the brand name Diovan before losing patent protection and then sold as a generic medication as valsartan. Following its release, Valsartan rapidly established itself as one of the most widely taken prescription medications globally in the competitive blood pressure drug market. In 2010, just four years after its launch, global sales for the drug exceeded $6 billion. When the original patent protection 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 July 2018, one of the main manufacturers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, first discovered that the raw Valsartan it was producing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical production lab which manufactures valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company manufactures the Valsartan compound then 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 largest wholesale producer of Valsartan component. During 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 totally unexpected. The NDMA contamination was apparently possible from a change in the process of making the drug that Zhejiang Huahai had chosen several years earlier.

The discovery created significant safety issues because of the known risks from NDMA. NDMA is a well-known leftover of certain chemical manufacturing procedurs. NDMA is classified as a carcinogen because it is known to cause cancer in humans. Many animal tests have proven that exposure or ingestion of simply tiny amounts of NDMA can 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 concerns regarding environmental contamination. The EPA classifies NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.

After realizing 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 officials to immediately recall all potentially contaminated versions of Valsartan. Since then, NDMA contamination has been observed 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 these labs revealed lower amounts of NDMA in relation to the Zhejiang Huahai product.

The top way to highlight how serious the issue with these tainted drugs is to point out that there is bipartisan support for further investigation in Congress. These people cannot agree on the hue of the sky but they agree that they require more information on what occurred with Valsartan.

Possible Injuries from Tainted Valsartan

NDMA is not merely a particularly dangerous carcinogen, but it may additionally be a poison at high levels. There has been several reported issues in which people died from internal bleeding and severe liver damage after ingesting high doses of NDMA on merely one occasion. In animal testing, ingesting high to moderate levels of NDMA caused major liver damage after just a few days and cancer after just a few months.

An investigation about the cause of the NDMA contamination has shown that it was probably caused by an alteration in the manufacturing process that Zhejiang Huahai started several years ago.

valsartan colon cancer means that Valsartan contaminated with NDMA was sold for many years before observation and recall. This is highly troubling because Valsartan is used as a maintenance drug which is taken daily on a continuing basis. This means that some patients could have been ingesting NDMA once or twice a day for several years. This sort of sustained long-term use is specifically the type of exposure that can 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 number of people who may develop cancer from exposure to NDMA is extremely large.

What Valsartan Patients Might Need to Know

If you have been taking Valsartan for symptoms of hypertension or other conditions, you can immediately consult with your prescribing physician regarding the possible dangers to your health. You should also find out what generic version of Valsartan you were getting from your pharmacy. Not all generic versions of Valsartan were contaminated with NDMA, although the list keeps growing as the research proceeds. In the United States the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

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

Of course, patients would like to understand what the possible settlement amount of the Valsartan case can be. It is a good question. The suffering victims might experience is significant and money compensation is all we have to reach towards justice. The Valsartan lawsuits are just too new to observe the potential settlement value of these claims. We will learn more as the litigation progresses. One note to settlement value is to have lawyers that are going after every possible penny and are determined to maximize the amount of your case for all that you have had to live with either as a victim or surviving family member.