Valsartan Can Create Cancer
Valsartan is a popular prescription medication taken to control hypertension and other heart issues. At the beginning of the 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 motivated the FDA and European health officials to issue worldwide safety recalls of the contaminated Valsartan products.
Valsartan is an antihypertensive drug 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 leading to higher blood pressure. The mechanism made Valsartan more effective than similar drugs before it that only worked by blocked the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).
Valsartan proved to be highly effective not only for patients with high blood pressure but additionally people with congestive heart failure. In a study, Valsartan was compared with Captopril and another ACE inhibitor post heart attack. The study found that Valsartan was as effective as Captopril at keeping heart failure at bay.
Another study found Valsartan reduced the risk of heart failure by some 20 percent compared to a placebo group. These results led the FDA to approve a label adjustment allowing Valsartan to be used by doctors for people with heart failure as well as hypertension.
Valsartan was originally developed by American pharmaceutical giant Novartis and it was approved for use by the FDA in 1996. It was marketed under the brand name Diovan prior to losing patent protection and being marketed as a generic medication as valsartan. Following its release, Valsartan rapidly established itself as one of the most widely taken prescription drugs globally in the competitive blood pressure medication market. In 2010, only four years after its launch, worldwide sales for the medication exceeded $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 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 makers of generic valsartan, the Chinese manufacturer Zhejiang Huahai Pharmaceuticals, first discovered that the raw Valsartan it was manufacturing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing laboratory that makes valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company manufactures the Valsartan compound and wholesales it to large pharmaceutical companies globally who then use it to make, package and sell their own generic variations of Valsartan. Zhejiang Huahai was by far the largest 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 inclusion of NDMA was entirely unexpected. The NDMA contamination was obviously possible from a change in the process of synthesizing the drug that Zhejiang Huahai had chosen many years before.
The realization created significant safety concerns because of the known dangers of NDMA. NDMA is a well-known byproduct of certain chemical manufacturing processes. NDMA is classified as a carcinogen because it is known to cause cancer in humans. Numerous animal studies have established that exposure or ingestion of even tiny amounts of NDMA might cause cancer in the liver, gastrointestinal system, and in the kidneys. In the past NDMA was used in the making of rocket fuel, but this use was halted due to issues regarding environmental contamination. The EPA classifies NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.
After uncovering the NDMA contamination, Zhejiang Huahai immediately notified pharmaceutical brands and safety agencies. This prompted the U.S. Food and Drug Administration (FDA) and European health agencies to immediately recall any possibly contaminated versions of Valsartan. Since that time, NDMA contamination has been found 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 laboratories revealed lower levels of NDMA compared to the Zhejiang Huahai product.
The best way to state how serious the issue with these contaminated medications is to show that there is bipartisan support for further investigation in Congress. These people can’t agree on the color of the sky but they agree that they need additional information on what occurred with Valsartan.
Potential Harm from Tainted Valsartan
NDMA is not merely a particularly dangerous carcinogen, but it may also be a poison at high levels. There have been several reported issues 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 levels of NDMA caused major liver damage after just a few days and cancer after just a few months.
An investigation about the cause of the NDMA contamination has revealed that it was most likely caused by an alteration in the manufacturing method that Zhejiang Huahai started a few years ago. valsartan colon cancer means that Valsartan tainted with NDMA was marketed for several years before observation and recall. This is extremely troubling because Valsartan is used as a maintenance medication which is taken daily on a continuing manner. This means that some patients may have been taking NDMA once or twice a day for many years. This type of continuous long-term ingestion is exactly the type of exposure that may cause cancer. NDMA exposure is linked to specific cancers such as:
Given the widespread use of Valsartan, the amount of patients who could develop cancer from exposure to NDMA is extremely large.
What Valsartan Users Should to Know
If you have been taking Valsartan for symptoms of hypertension or other conditions, you can immediately consult with your prescribing physician about the possible dangers to your health. You should also determine what generic version of Valsartan you were getting from your pharmacy. Not every generic versions of Valsartan were contaminated with NDMA, although the list continues to grow as the research continues. 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 May You Expect from a Valsartan Settlement?
Understandably, affected people would like to know what the potential settlement amount of the Valsartan case may be. It is a valid question. The suffering victims may experience is significant and money compensation is all we have to strive towards justice. The Valsartan lawsuits are simply too recent to observe the possible settlement value of these claims. We will understand more as the litigation continues. One key to settlement amount is to have lawyers that are fighting for every potential penny and are fighting to maximize the value of your case for all that you have had to live with either as a victim or surviving family member.