Valsartan Might Create Cancer

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 create cancer in humans. This information immediately prompted the FDA and European health officials to submit worldwide safety recalls of the contaminated Valsartan products.
About Valsartan
Valsartan is an antihypertensive medication that is used for controling high blood pressure and for people with congestive heart problems. It is also prescribed to people with ventricle dysfunction after suffering a heart attack. Valsartan works by effectively blocking angiotensin II - a peptide hormone that causes constriction of the blood vessels leading to higher blood pressure. The mechanism 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 patients with high blood pressure but also people with congestive heart failure. In a recent study, Valsartan was compared with Captopril and another ACE inhibitor post heart attack. The study found that Valsartan was as effective as Captopril in keeping heart failure minimized.

valsartan colon cancer found Valsartan minimized the risk of heart failure by approximately 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 patients with heart failure as well as hypertension.

Valsartan was originally developed by U.S. pharmaceutical corporation Novartis and it was approved for use by the FDA in 1996. It was marketed under the brand name Diovan before losing patent protection and being marketed as a generic drug as valsartan. After its release, Valsartan rapidly established itself as one of the most commonly used prescription drugs globally in the competitive blood pressure medication marketplace. In 2010, just four years after its release, worldwide sales for the medication surpassed $6 billion. When the original patent protection for Valsartan expired in 2012 a number of other pharmaceutical brands started to make generic variations 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 leading manufacturers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, initially realized that the raw Valsartan it was producing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing lab which manufactures valsartan and sells it through U.S. channels Prinston, Huahi and Solco. The company synthesizes the Valsartan component and wholesales it to major pharmaceutical companies globally who then use it to manufacture, package and market their own generic versions of Valsartan. Zhejiang Huahai was by far the largest wholesale manufacturer of Valsartan component. 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 apparently possible from an alteration in the process of making the drug that Zhejiang Huahai had chosen many years earlier.

The discovery created significant safety issues because of the known risks from 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 proven that exposure or ingestion of even tiny 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 halted due to issues about environmental contamination. The EPA classifies NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.

After realizing the NDMA contamination, Zhejiang Huahai immediately notified pharmaceutical companies and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health agencies to immediately recall any potentially contaminated versions of Valsartan. Since then, 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. Lab testing on the components from those laboratories showed lower levels of NDMA in relation to the Zhejiang Huahai product.

The top way to highlight how serious the issue with these tainted medications is to point out that there is bipartisan support for further investigation in Congress. These people cannot agree on the hue of the sky but they agree that they require more information on what occurred with Valsartan.
Possible Harm from Contaminated Valsartan
NDMA is not merely a very dangerous carcinogen, but it can also be a poison at high levels. There have been several reported cases in which people died from internal bleeding and severe 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 only several weeks.

An investigation about the cause of the NDMA contamination has shown that it was most likely created by a change in the production method that Zhejiang Huahai started several years ago. This means that Valsartan tainted with NDMA was marketed for many years prior to observation and recall. This is extremely troubling because Valsartan is used as a maintenance drug which is taken daily on a long-term basis. This means that some people might have been ingesting NDMA once or twice a day for several years. This kind of sustained long-term ingestion is exactly the type of exposure that could cause cancer. NDMA exposure is related to specific cancers such as:
Liver Cancer
Gastric Cancer
Colorectal Cancer
Kidney Cancer

Given the common ingestion of Valsartan, the amount of people who could 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 can immediately consult with your prescribing doctor about the potential dangers to your wellness. You should also determine what generic version of Valsartan you were receiving from your pharmacy. Not all generic versions of Valsartan were contaminated with NDMA, although the list keeps growing as the research continues. In the United States the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

How Much Money May You Anticipate from a Valsartan Settlement?
Understandably, patients want to know what the potential settlement value of the Valsartan case may be. It’s a valid question. The suffering patients could endure is extreme and money compensation is all we have to strive to justice. The Valsartan lawsuits are simply too recent to gauge the possible settlement value of these claims. We’ll understand more as the litigation progresses. A note to settlement amount is to have lawyers who are going after every potential penny and are fighting to maximize the amount of your case for all that you have had to live with either as a victim or surviving family member.