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Valsartan is a popular prescription drug taken to treat hypertension and various heart issues. At the beginning of the year it was discovered that some ingredients used to produce Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to create cancer in humans. This data immediately pushed the FDA and European health officials to submit global safety recalls of the tainted Valsartan products.

About Valsartan

Valsartan is an antihypertensive drug that is taken for the treatment of high blood pressure and for people with congestive heart problems. 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 creates constriction of the blood vessels leading to higher blood pressure. The mechanism made Valsartan more effective than similar drugs before it that merely worked by blocked the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).

Valsartan established itself to be highly effective not only for patients with high blood pressure but also 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.

An additional study determined Valsartan minimized the risk of heart failure by some 20 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 as well as hypertension.

Valsartan was originally created by American pharmaceutical giant Novartis and it was registered for use by the FDA in 1996. It was sold under the brand name Diovan prior to losing patent protection and then sold as a generic medication as valsartan. After its launch, Valsartan rapidly became one of the most frequently taken prescription drugs in the world in the competitive blood pressure medication market. In 2010, only 4 years after its release, worldwide revenue for the medication exceeded $6 billion. When the initial patent protection for Valsartan expired in 2012 a number of other pharmaceutical brands began making generic versions of the medication. 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 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 manufacturing laboratory which makes valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company manufactures the Valsartan compound and distributes it to major pharmaceutical companies globally who then use it to manufacture, package and market their own generic variations of Valsartan. Zhejiang Huahai was by far the biggest wholesale manufacturer of Valsartan compound. During 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 appearance of NDMA was totally unexpected. The NDMA contamination was obviously possible from an alteration in the method of making the medication that Zhejiang Huahai had adopted several years earlier.

The discovery created serious safety concerns due to the known dangers of NDMA. NDMA is a well-known byproduct of certain chemical making processes. 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 merely small amounts of NDMA may cause cancer in the liver, gastrointestinal system, and in the kidneys. In the past NDMA was used in the production of rocket fuel, but this use was stopped due to concerns regarding environmental contamination. The EPA classifies NDMA as a probable human carcinogen.

valsartan colon cancer is identified as a priority toxic pollutant in federal regulations.

After realizing 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 all potentially contaminated versions of Valsartan. Since that time, NDMA contamination has been observed in the valsartan components made by 2 other pharmaceutical wholesalers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from these labs showed lower levels of NDMA compared to the Zhejiang Huahai product.

The best manner to highlight how serious the issue with these tainted drugs is to point out that there is bipartisan support for continued investigation in Congress. These people cannot agree on the color of the sky but they agree that they need more information on what occurred with Valsartan.

Potential Harm from Tainted Valsartan

NDMA is not merely a particularly dangerous carcinogen, but it can additionally be a poison at high levels. There have 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 significant liver damage after just a few days and cancer after only a few months.

An investigation into the cause of the NDMA contamination has revealed that it was most likely created by an alteration in the production method that Zhejiang Huahai began many years ago. This means that Valsartan tainted with NDMA was sold for several years prior to realization 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 patients may have been ingesting NDMA once or twice a day for many years. This sort of continuous long-term ingestion is specifically the type of exposure that can cause cancer. NDMA exposure is linked to specific cancers like:

Liver Cancer

Gastric Cancer

Colorectal Cancer

Kidney Cancer

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

What Valsartan Users Need to Know

If you’ve been taking Valsartan for treatment of hypertension or other conditions, you should immediately consult with your prescribing doctor regarding the possible dangers to your health. You should also determine what generic version of Valsartan you were receiving from your pharmacy. Not every generic versions of Valsartan were tainted with NDMA, although the list continues to grow as the investigation proceeds. In the United States the safety recall only applied to the Valsartan made by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

How Much Money Might You Anticipate from a Valsartan Settlement?

Understandably, affected people would like to understand what the possible settlement amount of the Valsartan case could be. It is a valid question. The suffering users could 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’ll understand more as the litigation progresses. One note to settlement value is to have lawyers that are going after every potential dollar and are determined to maximize the amount of your case for everything that you have had to endure either as a victim or surviving family member.