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Valsartan is a widely-used prescription medication taken to control hypertension and various heart issues. Earlier this year it was observed that certain ingredients used to manufacture Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. This data immediately motivated the FDA and European health agencies to submit global safety recalls of the tainted Valsartan products.

About Valsartan

Valsartan is an antihypertensive drug that is taken for controling high blood pressure and for people with congestive heart issues. It’s also prescribed to patients with ventricle dysfunction after suffering a heart attack.

valsartan colon cancer works by effectively blocking angiotensin II – a peptide hormone that causes constriction of the blood vessels promoting higher blood pressure. This mechanism made Valsartan more efficient than similar medications before it that merely worked by blocked the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).

Valsartan proved to be highly effective not only for patients with high blood pressure but also people with congestive heart failure. In a recent study, Valsartan was measured against Captopril and another ACE inhibitor post heart attack. The research found that Valsartan was as effective as Captopril in keeping heart failure minimized.

Another study determined Valsartan reduced the risk of heart failure by approximately twenty percent compared to a placebo group. These results motivated the FDA to approve a label adjustment permitting Valsartan to be used by doctors for patients with heart failure in addition to hypertension.

Valsartan was originally developed by American pharmaceutical company Novartis and it was approved for use by the FDA in 1996. It was marketed under the brand name Diovan prior to losing patent protection and being sold as a generic medication as valsartan. Following its launch, Valsartan quickly established itself as one of the most widely taken prescription drugs in the world in the competitive blood pressure drug market. In 2010, only 4 years after its release, global revenue for the medication surpassed $6 billion. When the initial patent protection for Valsartan expired in 2012 a number of other pharmaceutical brands 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 main makers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, first discovered that the raw Valsartan it was making was contaminated. Zhejiang Huahai is a wholesale pharmaceutical production laboratory that manufactures valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company manufactures 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 largest wholesale producer of Valsartan compound. During 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 appearance of NDMA was entirely unexpected. The NDMA contamination was obviously caused by a change in the method of making the drug that Zhejiang Huahai had chosen many years before.

The discovery raised significant safety issues because of the known risks from NDMA. NDMA is a well-known byproduct of certain chemical making processes. NDMA is classified as a carcinogen because it is known to cause cancer in humans. Many animal tests have established that exposure or ingestion of merely minute 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 halted 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 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 observed in the valsartan components produced by 2 other pharmaceutical suppliers: 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 highlight how serious the issue with these contaminated drugs is to show that there is wide support for continued investigation in Congress. These people cannot agree on the color of the sky but they agree that they require additional data on what occurred with Valsartan.

Possible Harm from Tainted Valsartan

NDMA is not only a very dangerous carcinogen, but it can additionally be a poison at high levels. There have been many reported issues in which people died from internal bleeding and severe liver damage after taking high doses of NDMA on only 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 a few months.

An investigation into the cause of the NDMA contamination has revealed that it was probably caused by a change in the production process that Zhejiang Huahai started a few years ago. This means that Valsartan contaminated with NDMA was sold for many years prior to realization and recall. This is highly disturbing because Valsartan is used as a maintenance drug which is taken daily on a continuing basis. This means that some people might have been taking NDMA once or twice a day for many years. This sort of sustained long-term ingestion is exactly the kind of exposure that can cause cancer. NDMA exposure is linked to specific cancers such as:

Liver Cancer

Gastric Cancer

Colorectal Cancer

Kidney Cancer

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

What Valsartan Patients Might Need to Know

If you have been taking Valsartan for symptoms of hypertension or other conditions, you should immediately meet with your prescribing doctor regarding the possible dangers to your health. You should also determine what generic version of Valsartan you were getting from your pharmacy. Not every generic versions of Valsartan were contaminated with NDMA, though 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 Might You Expect from a Valsartan Settlement?

Of course, people would like to understand what the possible settlement value of the Valsartan case might be. It’s a great question. The suffering patients could endure is extreme and money compensation is all we have to reach to justice. The Valsartan lawsuits are simply too recent to gauge the potential settlement amount of these claims. We will learn more as the litigation continues. One key to settlement amount is to have lawyers who are fighting for every potential penny 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.