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Valsartan is a popular prescription drug used to control hypertension and other heart conditions. Earlier this 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 tainted Valsartan products.

About Valsartan

Valsartan is an antihypertensive medication that is used 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 causes constriction of the blood vessels promoting higher blood pressure. The functionality made Valsartan more effective 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 one 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 minimized.

Another report determined Valsartan minimized the risk of heart failure by some twenty percent measured against a placebo group. These results led the FDA to approve a label adjustment permitting Valsartan to be prescribed by physicians for people with heart failure in addition to hypertension.

Valsartan was originally created by American pharmaceutical giant Novartis and it was approved for use by the FDA in 1996. It was made available under the brand name Diovan prior to losing patent protection and being marketed as a generic drug as valsartan. Following its release, Valsartan quickly became one of the most commonly taken prescription medications globally in the competitive blood pressure drug marketplace. In 2010, just four years after its launch, worldwide revenue for the medication exceeded $6 billion. When the initial patent protection for Valsartan expired in 2012 many other pharmaceutical companies began making generic variations of the medication. The largest 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 company Zhejiang Huahai Pharmaceuticals, first realized that the raw Valsartan it was producing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing lab that makes

valsartan and distributes it through U.S. channels Prinston, Huahi and Solco. The company manufactures the Valsartan compound then wholesales it to major pharmaceutical companies around the world who then use it to make, package and sell their own generic variations 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 revealed that the batches of Valsartan it was producing were dangerously contaminated with N-nitrosodimethylamine (NMDA). The presence of NDMA was totally unexpected. The NDMA contamination was apparently caused by an alteration in the method of synthesizing the medication that Zhejiang Huahai had employed several years earlier.

The discovery created significant safety concerns because of the known dangers of NDMA. NDMA is a well-known byproduct of certain chemical manufacturing procedurs. NDMA is named as a carcinogen because it is known to cause cancer in humans. Numerous animal tests have established that exposure or ingestion of simply minute amounts of NDMA may 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 halted due to concerns about environmental contamination. The EPA regards NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.

After discovering the NDMA contamination, Zhejiang Huahai promptly notified pharmaceutical companies and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health officials to immediately recall any possibly affected versions of Valsartan. Since that time, NDMA contamination has been discovered 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 levels of NDMA compared to the Zhejiang Huahai product.

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

Potential Injuries from Contaminated Valsartan

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

An investigation about the cause of the NDMA contamination has shown that it was most likely caused by a change in the manufacturing method that Zhejiang Huahai began many years ago. This means that Valsartan contaminated with NDMA was on the market for many years prior to observation and recall. This is extremely distressing because Valsartan is used as a maintenance drug which is taken daily on a long-term basis. This means that some people may have been ingesting NDMA once or twice a day for many years. This type of sustained long-term ingestion is specifically the type of exposure that may cause cancer. NDMA exposure is related to specific cancers such as:

Liver Cancer

Gastric Cancer

Colorectal Cancer

Kidney Cancer

Given the global ingestion of Valsartan, the number of people who might suffer from 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 issues, you should immediately consult with your prescribing doctor regarding the possible dangers to your wellness. You should also determine what generic version of Valsartan you were getting from your pharmacy. Not all generic versions of Valsartan were tainted with NDMA, although the list keeps growing as the research continues. In the U.S. the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

How Much Money Might You Anticipate from a Valsartan Settlement?

Of course, people want to know what the potential settlement amount of the Valsartan case can be. It is a good question. The suffering patients could endure is significant and money compensation is all we have to reach to justice. The Valsartan lawsuits are just too new to observe the potential settlement amount of these claims. We will learn more as the litigation continues. One key to settlement value is to have lawyers who are fighting for every potential penny and are fighting to maximize the amount of your case for everything that you have had to live with either as a victim or surviving family member.