Valsartan is a popular prescription drug taken to treat hypertension and various heart conditions. Earlier this year it was observed that certain ingredients used to produce Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to create cancer in humans. This information immediately pushed the FDA and European health agencies to issue worldwide safety recalls of the contaminated Valsartan products. About Valsartan Valsartan is an antihypertensive drug that is taken for controling high blood pressure and for people with congestive heart problems. It’s 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 drugs before it that merely 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 one study, Valsartan was compared with Captopril and another ACE inhibitor post heart attack. The research determined that Valsartan was as effective as Captopril in keeping heart failure at bay.
Yet another report determined Valsartan minimized the risk of heart failure by approximately 20 percent compared to a placebo group. The results motivated the FDA to approve a label change allowing Valsartan to be prescribed by doctors for patients with heart failure as well as hypertension.
Valsartan was initially created by American pharmaceutical company Novartis and it was registered for use by the FDA in 1996. It was sold under the brand name Diovan before losing patent protection and then marketed as a generic drug as valsartan. Following its launch, Valsartan rapidly became one of the most frequently used prescription medications in the world in the competitive blood pressure medication marketplace. In 2010, just 4 years after its release, worldwide sales for the medication exceeded $6 billion. When the original patent period for Valsartan expired in 2012 many other pharmaceutical brands started to make generic variations 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 manufacturer Zhejiang Huahai Pharmaceuticals, initially realized that the raw Valsartan it was manufacturing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing laboratory which manufactures valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company synthesizes the Valsartan component then distributes it to major pharmaceutical companies around the world who then use it to manufacture, package and sell their own generic versions of Valsartan. Zhejiang Huahai was by far the biggest wholesale producer of Valsartan component. Sometime in late June 2018, quality control tests at Zhejiang Huahai determined 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 caused by a change in the process of synthesizing the drug that Zhejiang Huahai had adopted several years earlier.
The discovery created serious safety concerns due to the known dangers of NDMA. NDMA is a well-known result of certain chemical making processes. NDMA is named as a carcinogen because it is known to cause cancer in humans. Numerous animal tests have established that exposure or ingestion of merely minute amounts of NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the making of rocket fuel, however this use was stopped 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 uncovering the NDMA contamination, Zhejiang Huahai promptly notified pharmaceutical companies and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health officials to immediately recall any possibly affected versions of Valsartan. Since then, NDMA contamination has been discovered in the valsartan components made by 2 other pharmaceutical suppliers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from those laboratories revealed lower amounts of NDMA in relation to the Zhejiang Huahai product.
The top way to show how serious the problem with these tainted medications is to point out that there is wide support for further investigation in Congress. These people can’t agree on the hue of the sky but are in agreement that they require additional information on what occurred with Valsartan. Potential Injuries from Contaminated Valsartan NDMA is not only a particularly dangerous carcinogen, but it might also 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 just one occasion. In animal testing, ingesting high to moderate levels of NDMA caused significant liver damage after only a few days and cancer after only a few months.
An investigation into the cause of the NDMA contamination has revealed that it was probably created by an alteration in the production process that Zhejiang Huahai began a few years ago. This means that Valsartan contaminated with NDMA was marketed for several years prior to realization and recall. This is very troubling because Valsartan is used as a maintenance drug which is taken daily on a long-term manner. This means that some people might have been ingesting NDMA once or twice a day for several years. This type of continuous long-term use 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 use of Valsartan, the number of people who may develop cancer from exposure to NDMA is very large.
What Valsartan Patients Should to Realize If you’ve been taking Valsartan for symptoms of hypertension or other issues, you should immediately meet 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 all generic versions of Valsartan were tainted with NDMA, though the list keeps growing 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 May You Expect from a Valsartan Settlement? Of course, affected people want to understand what the potential settlement value of the Valsartan case might be. It’s a valid question. valsartan law suit suffering users might 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 amount of these claims. We’ll understand more as the litigation continues. A key to settlement value is to have lawyers who are fighting for every potential dollar and are determined to maximize the amount of your case for everything that you have had to live with either as a victim or surviving family member.
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