Valsartan May Create Cancer

Valsartan is a widely-used prescription medication used to control hypertension and other heart conditions. 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 information immediately prompted the FDA and European health agencies to submit worldwide safety recalls of the tainted Valsartan products.
About Valsartan
Valsartan is an antihypertensive drug that is taken for controling high blood pressure and 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 functionality made Valsartan more efficient than similar medications before it that only worked by stopping the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).

Valsartan proved to be highly effective not only for people with high blood pressure but also people with congestive heart failure. In one study, Valsartan was measured against Captopril and another ACE inhibitor after a heart attack. valsartan stomach cancer determined that Valsartan was as effective as Captopril at keeping heart failure minimized.

An additional study determined Valsartan reduced the risk of heart failure by some 20 percent measured against a placebo group. These results led the FDA to approve a label change allowing Valsartan to be prescribed by doctors for people with heart failure as well as hypertension.

Valsartan was initially created by American pharmaceutical corporation Novartis and it was approved for use by the FDA in 1996. It was sold under the brand name Diovan prior to losing patent protection and being marketed as a generic drug as valsartan. After its release, Valsartan quickly established itself as one of the most widely used prescription drugs in the world in the competitive blood pressure medication market. In 2010, just 4 years after its launch, global sales for the drug surpassed $6 billion. When the original patent protection for Valsartan expired in 2012 a number of other pharmaceutical corporations started to make generic variations 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 main manufacturers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, first realized that the raw Valsartan it was making was contaminated. Zhejiang Huahai is a wholesale pharmaceutical production lab that manufactures valsartan and distributes it through U.S. channels Prinston, Huahi and Solco. The company manufactures the Valsartan compound then wholesales it to large 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. Sometime in 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 inclusion of NDMA was totally unexpected. The NDMA contamination was obviously possible from a change in the process of synthesizing the medication that Zhejiang Huahai had adopted several years earlier.

The discovery raised significant safety issues because of the known dangers of NDMA. NDMA is a well-known byproduct of certain chemical making procedurs. NDMA is named as a carcinogen because it is known to cause cancer in humans. Many animal tests have determined that exposure or ingestion of simply tiny amounts of NDMA may cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the manufacture of rocket fuel, but this use was halted because of 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 realizing the NDMA contamination, Zhejiang Huahai promptly notified pharmaceutical brands and safety agencies. 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 found in the valsartan components produced by two other pharmaceutical wholesalers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from those labs revealed lower amounts of NDMA in relation to the Zhejiang Huahai product.

The most effective manner to highlight how serious the problem with these contaminated drugs is to point out that there is bipartisan support for further investigation in Congress. Congress cannot agree on the hue of the sky but are in agreement that they require additional information on what happened with Valsartan.
Potential Harm from Tainted Valsartan
NDMA is not only a particularly dangerous carcinogen, but it might additionally be a poison at high levels. There have been many reported issues in which people died from internal bleeding and significant liver damage after ingesting high doses of NDMA on only 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 several weeks.

An investigation into the cause of the NDMA contamination has shown that it was most likely caused by an alteration in the manufacturing method that Zhejiang Huahai started a few years ago. This means that Valsartan contaminated with NDMA was sold for several years prior to discovery and recall. This is very troubling because Valsartan is used as a maintenance medication which is ingested daily on a long-term basis. This means that some users might have been taking NDMA once or twice a day for many years. This sort 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 patients who might develop cancer from exposure to NDMA is very large.

What Valsartan Patients Should to Realize
If you have been taking Valsartan for symptoms of hypertension or other issues, you can immediately meet with your prescribing physician about the possible dangers to your wellness. You should also find out what generic version of Valsartan you were receiving from your pharmacy. Not all generic versions of Valsartan were contaminated with NDMA, though the list continues to grow as the research proceeds. In the U.S. the safety recall only applied to the Valsartan made by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.

What Amount of Money Can You Anticipate from a Valsartan Settlement?
Of course, people want to know what the potential settlement amount of the Valsartan case can be. It’s a good question. The suffering users might experience is significant and money compensation is all we have to reach to justice. The Valsartan lawsuits are simply too new to gauge the possible settlement amount of these claims. We’ll learn more as the litigation progresses. A note to settlement value is to have lawyers who are fighting for every possible dollar 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.