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Valsartan is a popular prescription drug taken to treat hypertension and various heart conditions. At the beginning of the year it was discovered that certain ingredients used to manufacture Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. This information immediately motivated the FDA and European health agencies to submit 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 issues. It is also prescribed to patients 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. The mechanism made Valsartan more effective than similar medications before it that merely worked by stopping 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 patients with congestive heart failure. In one study, Valsartan was measured against Captopril and another ACE inhibitor post heart attack. The study determined that Valsartan was as effective as Captopril in keeping heart failure at bay.

Another study determined 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 people with heart failure in addition to hypertension.

Valsartan was originally created by U.S. pharmaceutical giant Novartis and it was registered for use by the FDA in 1996. It was marketed under the brand name Diovan prior to losing patent protection and then marketed as a generic drug as valsartan. After its release, Valsartan quickly became one of the most commonly taken prescription drugs in the world in the competitive blood pressure medication market. In 2010, only four years after its release, worldwide sales for the drug surpassed $6 billion. When the initial patent period for Valsartan expired in 2012 a number of other pharmaceutical brands started to make 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 makers 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 that manufactures valsartan and sells it through U.S. affiliates Prinston, Huahi and Solco. The company synthesizes the Valsartan compound and wholesales it to large pharmaceutical companies globally 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 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 presence of NDMA was totally unexpected. The NDMA contamination was obviously possible from a change in the process of producing the medication that Zhejiang Huahai had chosen many years earlier.

The realization raised significant safety issues due to the known dangers of NDMA. NDMA is a well-known leftover of certain chemical manufacturing procedurs. NDMA is named as a carcinogen because it is known to cause cancer in humans. Numerous animal tests have proven 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 manufacture of rocket fuel, however this use was stopped due to concerns about environmental contamination. The EPA classifies NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.

After discovering 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 any potentially affected versions of Valsartan. Since then, NDMA contamination has been observed in the valsartan components produced by 2 other pharmaceutical wholesalers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Lab testing on the components from these laboratories showed lower amounts of NDMA in relation to the Zhejiang Huahai product.

The most effective way to show how serious the problem with these tainted medications is to point out that there is wide support for continued investigation in Congress. Congress cannot agree on the hue of the sky but are in agreement that they want additional data on what happened with Valsartan.

Possible Harm from Tainted Valsartan

NDMA is not merely a particularly dangerous carcinogen, but it might also be a poison at high levels. There has been many reported cases in which people died from internal bleeding and significant liver damage after ingesting high doses of NDMA on just one occasion. In animal testing, taking high to moderate amounts of NDMA caused major liver damage after only a few days and cancer after just several weeks.

An investigation into the cause of the NDMA contamination has revealed that it was probably created by an alteration in the production process that Zhejiang Huahai started several years ago. This means that Valsartan contaminated with NDMA was sold for many years before discovery and recall. This is highly distressing because Valsartan is used as a maintenance medication which is ingested daily on a long-term basis.

valsartan cancer means that some patients might have been taking NDMA once or twice a day for several years. This type of sustained long-term ingestion is specifically the kind of exposure that could 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 people who may suffer from cancer from exposure to NDMA is very large.

What Valsartan Patients Might Need to Realize

If you’ve been taking Valsartan for symptoms of hypertension or other conditions, you should immediately meet with your prescribing doctor about the potential 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, 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 Expect from a Valsartan Settlement?

Understandably, affected people want to know what the potential settlement amount of the Valsartan case can be. It’s a great question. The suffering users may experience is significant and money compensation is all we have to reach to justice. The Valsartan lawsuits are simply too new to gauge the potential settlement value of these claims. We will learn more as the litigation progresses. 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.