Valsartan is a widely-used prescription medication used to control hypertension and other heart conditions. Earlier this year it was discovered that certain ingredients used to produce Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. This information immediately pushed the FDA and European health agencies to create worldwide safety recalls of the contaminated 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 people 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 mechanism made Valsartan more efficient than similar medications before it that merely 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 people 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 minimized.
Another study found Valsartan reduced the risk of heart failure by approximately 20 percent measured against a placebo group. The results motivated the FDA to approve a label adjustment permitting Valsartan to be prescribed by physicians for patients with heart failure in addition to hypertension.
Valsartan was initially developed by U.S. pharmaceutical company Novartis and it was registered for use by the FDA in 1996. It was marketed under the brand name Diovan prior to losing patent protection and being sold as a generic medication as valsartan. Following its release, Valsartan rapidly established itself as one of the most frequently used prescription drugs globally in the competitive blood pressure drug market. In 2010, just four years after its launch, global revenue for the medication exceeded $6 billion. When the original patent period for Valsartan expired in 2012 a number of other pharmaceutical brands started to make generic variations of the medication. The largest generic manufacturers of Valsartan were Teva Pharmaceuticals Industries Ltd. and Solco Healthcare Inc. Contamination of Valsartan with NDMA In 2018, one of the main makers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, initially discovered that the raw Valsartan it was making was contaminated. Zhejiang Huahai is a wholesale pharmaceutical production laboratory that manufactures valsartan and sells it through U.S. affiliates Prinston, Huahi and Solco. The company manufactures the Valsartan component then wholesales it to major pharmaceutical companies around the world who then use it to manufacture, package and market their own generic variations of Valsartan. Zhejiang Huahai was by far the largest wholesale manufacturer of Valsartan compound. Sometime in late June 2018, quality control tests at Zhejiang Huahai revealed 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 apparently possible from an alteration in the method of synthesizing the drug that Zhejiang Huahai had employed many years before.
The realization raised serious safety issues due to the known dangers of NDMA. NDMA is a well-known result of certain chemical manufacturing processes. NDMA is classified as a carcinogen because it is known to cause cancer in humans. Many animal studies have proven that exposure or ingestion of simply minute amounts of NDMA may cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the production of rocket fuel, but this use was stopped due to issues 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 promptly notified pharmaceutical brands and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health agencies to immediately recall all possibly contaminated versions of Valsartan. Since then, NDMA contamination has been observed 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 levels of NDMA in relation to the Zhejiang Huahai product.
The most effective manner to state how dangerous the problem with these contaminated medications is to show that there is bipartisan support for continued investigation in Congress. These people cannot agree on the hue of the sky but they agree that they want additional information on what happened with Valsartan. Potential Harm from Tainted Valsartan NDMA is not merely a very dangerous carcinogen, but it might also be a poison at high levels. There has been several reported cases in which people died from internal bleeding and significant liver damage after taking high doses of NDMA on only one occasion. In animal testing, ingesting high to moderate amounts of NDMA caused significant liver damage after only a few days and cancer after just a few months.
An investigation about the cause of the NDMA contamination has revealed that it was probably created by a change in the manufacturing process that Zhejiang Huahai started several years ago. This means that Valsartan contaminated with NDMA was sold for several years prior to discovery 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 patients may have been ingesting NDMA once or twice a day for many years. This type of sustained long-term use is exactly 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 amount of patients who could develop cancer from exposure to NDMA is extremely large.
What Valsartan Users Might Need to Realize If you have been taking Valsartan for treatment of hypertension or other issues, you should immediately consult with your prescribing doctor about the possible dangers to your health. 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 U.S. the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.
How Much Money Can You Anticipate from a Valsartan Settlement? Understandably, patients would like to understand what the possible settlement value of the Valsartan case might be. It is a valid question. The suffering patients may endure is extreme and money compensation is all we have to strive towards justice. The Valsartan lawsuits are just too recent to observe the possible settlement value of these claims. We will learn more as the litigation progresses. valsartan colon cancer 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 everything that you have had to live with either as a victim or surviving family member.
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