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Valsartan is a popular prescription medication taken to control hypertension and other heart issues. Earlier this year it was observed that certain ingredients used to produce Valsartan were contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to create cancer in humans. This data immediately pushed the FDA and European health officials to issue worldwide safety recalls of the tainted 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 issues. 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 promoting higher blood pressure. The mechanism made Valsartan more effective than similar medications 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 also people with congestive heart failure. In a recent study, Valsartan was compared with Captopril and another ACE inhibitor post heart attack. The research found that Valsartan was as effective as Captopril at keeping heart failure at bay.

Yet another study found Valsartan minimized the risk of heart failure by some 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 patients with heart failure as well as hypertension.

Valsartan was originally created by American pharmaceutical company 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 medication as valsartan. After its launch, Valsartan rapidly became one of the most widely taken prescription medications in the world in the competitive blood pressure medication marketplace. In 2010, just 4 years after its launch, global revenue for the drug exceeded $6 billion. When the initial patent protection for Valsartan expired in 2012 many other pharmaceutical brands started to make 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 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 production laboratory that makes valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company manufactures 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 versions of Valsartan. Zhejiang Huahai was by far the largest wholesale producer of Valsartan compound. 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 entirely unexpected. The NDMA contamination was obviously possible from an alteration in the method of producing the medication that Zhejiang Huahai had chosen many years earlier.

The realization raised significant safety concerns due to the known risks from NDMA. NDMA is a well-known result of certain chemical making procedurs. NDMA is reported as a carcinogen because it is known to cause cancer in humans. Numerous animal studies have determined that exposure or ingestion of simply small amounts of NDMA can 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 halted because of issues regarding environmental contamination. The EPA regards NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.

After uncovering the NDMA contamination, Zhejiang Huahai immediately alerted pharmaceutical brands and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health agencies to immediately recall all possibly contaminated versions of Valsartan. Since that time, NDMA contamination has been found 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 those labs revealed lower amounts of NDMA compared to the Zhejiang Huahai product.

The top way to show how dangerous the problem with these tainted drugs is to point out that there is wide support for continued investigation in Congress. Congress cannot agree on the color of the sky but they agree that they require additional information on what happened with Valsartan.

Potential Injuries from Tainted Valsartan

NDMA is not merely a particularly dangerous carcinogen, but it might additionally be a poison at high levels. There has been many 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 levels of NDMA caused significant liver damage after only a few days and cancer after only a few months.

An investigation about the cause of the NDMA contamination has shown that it was most likely caused by a change in the production process that Zhejiang Huahai began a few years ago. This means that Valsartan contaminated with NDMA was on the market for several years prior to observation and recall. This is highly troubling because Valsartan is used as a maintenance medication which is ingested daily on a continuing manner. This means that some users could have been taking NDMA once or twice a day for several years. This kind of continuous long-term ingestion is exactly the type of exposure that might cause cancer. NDMA exposure is related to specific cancers like:

Liver Cancer

Gastric Cancer

Colorectal Cancer

Kidney Cancer

Given the global use of Valsartan, the number of patients who may develop cancer from exposure to NDMA is very large.

What Valsartan Patients Need to Know

If you’ve been taking Valsartan for symptoms of hypertension or other issues, you can immediately consult with your prescribing physician regarding the potential dangers to your health. You should also determine what generic version of Valsartan you were receiving from your pharmacy. Not all generic versions of Valsartan were contaminated with NDMA, though the list keeps growing as the research proceeds. 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 Anticipate from a Valsartan Settlement?

Of course, affected people would like to understand what the possible settlement value of the Valsartan case might be. It is a good question. The suffering patients could endure is significant and money compensation is all we have to strive to justice. The Valsartan lawsuits are just too new to determine the potential settlement amount of these claims.

valsartan cancer ’ll learn more as the litigation progresses. A key to settlement amount is to have lawyers who are going after every potential dollar and are fighting to maximize the value of your case for everything that you have had to endure either as a victim or surviving family member.