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Valsartan Can Lead To Cancer

από Marita Dockery (2019-08-19)


Valsartan is a popular prescription medication taken to treat hypertension and other heart issues. At the beginning of the year it was observed that some ingredients used to manufacture Valsartan were contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to create cancer in humans. This data immediately pushed the FDA and European health agencies to issue worldwide safety recalls of the contaminated Valsartan products.
About Valsartan
Valsartan is an antihypertensive medication 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 creates constriction of the blood vessels promoting higher blood pressure. This mechanism made Valsartan more effective than similar drugs 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 people with congestive heart failure. In a recent study, Valsartan was measured against Captopril and another ACE inhibitor after a heart attack. The research determined that Valsartan was as effective as Captopril in keeping heart failure at bay.

Yet another report found Valsartan minimized the risk of heart failure by approximately twenty percent compared to a placebo group. The results motivated the FDA to approve a label adjustment permitting Valsartan to be used by doctors 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 sold as a generic drug as valsartan. After its launch, Valsartan rapidly established itself as one of the most commonly used prescription medications globally in the competitive blood pressure drug marketplace. In 2010, only four years after its launch, worldwide sales for the drug surpassed $6 billion. When the original patent period for Valsartan expired in 2012 a number of other pharmaceutical corporations started to make generic versions 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 makers 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 manufacturing laboratory that makes valsartan and distributes it through U.S. channels Prinston, Huahi and Solco. The company synthesizes the Valsartan component then wholesales it to large pharmaceutical companies globally who then use it to make, package and market 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 entirely unexpected. The NDMA contamination was apparently caused by a change in the process of synthesizing the drug that Zhejiang Huahai had adopted many years before.

The realization created serious safety issues due to the known risks from NDMA. NDMA is a well-known result of certain chemical making procedurs. NDMA is classified as a carcinogen because it is known to cause cancer in humans. Numerous animal tests have established that exposure or ingestion of merely tiny 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 stopped due to concerns regarding environmental contamination. The EPA regards NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.

After realizing the NDMA contamination, Zhejiang Huahai promptly 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 then, NDMA contamination has been found in the valsartan components made by two other pharmaceutical suppliers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from these labs revealed lower levels of NDMA in relation to the Zhejiang Huahai product.

The most effective way to highlight how dangerous the problem with these tainted drugs is to point out that there is wide support for continued investigation in Congress. These people can’t agree on the hue of the sky but are in agreement that they require more information on what happened with Valsartan.
Possible Injuries from Tainted Valsartan
NDMA is not merely a very dangerous carcinogen, but it can also be a poison at high levels. There has been several reported cases in which people died from internal bleeding and significant liver damage after ingesting high doses of NDMA on merely one occasion. In animal testing, taking high to moderate amounts 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 created by an alteration in the production method that Zhejiang Huahai started a few years ago. This means that Valsartan tainted with NDMA was marketed for several years before discovery and recall. This is very disturbing because Valsartan is used as a maintenance drug which is ingested daily on a continuing manner. This means that some users might have been taking NDMA once or twice a day for many years. This type of continuous long-term use 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 widespread use of Valsartan, the amount of patients who might suffer from 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 conditions, you should immediately meet with your prescribing physician regarding the potential dangers to your health. You should also find out what generic version of Valsartan you were getting from your pharmacy. Not all generic versions of Valsartan were tainted with NDMA, though the list continues to grow as the investigation proceeds. In the U.S. the safety recall only applied to the valsartan colon cancer made by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

How Much Money May You Anticipate from a Valsartan Settlement?
Of course, patients want to understand what the possible settlement amount of the Valsartan case could be. It is a great question. The suffering users might experience is significant and money compensation is all we have to strive to justice. The Valsartan lawsuits are simply too new to determine the possible settlement value of these claims. We will learn more as the litigation continues. One key to settlement amount is to have lawyers who are going after every possible penny and are fighting to maximize the amount of your case for everything that you have had to endure either as a victim or surviving family member.