Valsartan Might Create Cancer

Valsartan is a widely-used prescription drug taken to treat hypertension and various heart issues. At the beginning of the year it was discovered that certain ingredients used to make 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 global safety recalls of the tainted Valsartan products.
About Valsartan
Valsartan is an antihypertensive medication that is used for the treatment of high blood pressure and for people with congestive heart issues. It is also prescribed to individuals 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 mechanism made Valsartan more effective than similar medications before it that only worked by blocked the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).

Valsartan established itself to be very effective not only for patients with high blood pressure but additionally patients with congestive heart failure. In a study, Valsartan was measured against Captopril and another ACE inhibitor post heart attack. The research determined that Valsartan was as effective as Captopril at keeping heart failure minimized.

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 allowing Valsartan to be used by doctors for patients with heart failure as well as hypertension.

Valsartan was originally developed by American pharmaceutical corporation Novartis and it was registered for use by the FDA in 1996. It was made available under the brand name Diovan before losing patent protection and being sold as a generic drug as valsartan. Following its release, Valsartan rapidly established itself as one of the most commonly used prescription medications in the world in the competitive blood pressure drug marketplace. In 2010, just 4 years after its release, global revenue for the drug exceeded $6 billion. When the original patent period for Valsartan expired in 2012 many other pharmaceutical corporations began making generic versions of the drug. The largest generic manufacturers of Valsartan were Teva Pharmaceuticals Industries Ltd. and Solco Healthcare Inc.
Contamination of Valsartan with NDMA
In July 2018, one of the main makers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, initially discovered that the raw Valsartan it was manufacturing 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 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 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 inclusion of NDMA was totally unexpected. The NDMA contamination was obviously caused by an alteration in the method of synthesizing the drug that Zhejiang Huahai had employed many years earlier.

The realization raised significant safety concerns due to the known dangers of NDMA. NDMA is a well-known leftover of certain chemical making processes. NDMA is reported as a carcinogen because it is known to cause cancer in humans. Many animal studies have established that exposure or ingestion of simply tiny amounts of NDMA might cause cancer in the liver, gastrointestinal system, and in the kidneys. In the past NDMA was used in the production of rocket fuel, however this use was halted because of 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 immediately notified pharmaceutical brands and safety officials. This prompted the U.S. valsartan colon cancer and Drug Administration (FDA) and European health officials to immediately recall any potentially contaminated versions of Valsartan. Since then, NDMA contamination has been discovered in the valsartan components made by two other pharmaceutical suppliers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Lab testing on the components from these laboratories revealed lower amounts of NDMA in relation to the Zhejiang Huahai product.

The most effective manner to show how dangerous the problem with these tainted medications is to point out that there is bipartisan support for further investigation in Congress. Congress cannot agree on the hue of the sky but they agree that they need more data on what happened with Valsartan.
Possible Harm from Tainted Valsartan
NDMA is not only a very dangerous carcinogen, but it might also be a poison at high levels. There has been several reported issues in which people died from internal bleeding and significant liver damage after taking high doses of NDMA on only one occasion. In animal testing, taking high to moderate levels of NDMA caused major liver damage after just a few days and cancer after just several weeks.

An investigation into the cause of the NDMA contamination has revealed that it was most likely caused by an alteration in the production method that Zhejiang Huahai started several years ago. This means that Valsartan contaminated with NDMA was marketed for many years before realization and recall. This is highly distressing because Valsartan is used as a maintenance medication which is ingested daily on a continuing manner. This means that some users may have been taking NDMA once or twice a day for many years. This sort of sustained long-term use is specifically the kind of exposure that might cause cancer. NDMA exposure is related to specific cancers such as:
Liver Cancer
Gastric Cancer
Colorectal Cancer
Kidney Cancer

Given the common use of Valsartan, the number of patients who may develop cancer from exposure to NDMA is extremely large.

What Valsartan Users Might Need to Realize
If you have been taking Valsartan for symptoms of hypertension or other conditions, you can immediately meet with your prescribing physician regarding the possible dangers to your wellness. You should also find out what generic version of Valsartan you were getting from your pharmacy. Not every generic versions of Valsartan were contaminated with NDMA, though the list keeps growing 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.

What Amount of Money Can You Expect from a Valsartan Settlement?
Of course, affected people would like to know what the potential settlement value of the Valsartan case could be. It’s a valid question. The suffering patients may experience 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 will learn more as the litigation continues. One note to settlement value is to have lawyers who are going after every potential penny and are determined to maximize the value of your case for all that you have had to live with either as a victim or surviving family member.