Valsartan is a widely-used prescription drug used to treat hypertension and other heart issues. At the beginning of the year it was observed that some ingredients used to produce Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. This information immediately motivated the FDA and European health agencies to submit global safety recalls of the tainted Valsartan products. About Valsartan Valsartan is an antihypertensive drug that is taken 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 causes constriction of the blood vessels promoting higher blood pressure. This functionality 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 people with high blood pressure but also people with congestive heart failure. In a recent study, Valsartan was measured against Captopril and another ACE inhibitor post heart attack. The research determined that Valsartan was as effective as Captopril in keeping heart failure minimized.
An additional report determined Valsartan reduced the risk of heart failure by some twenty percent compared to a placebo group. These results motivated the FDA to approve a label change permitting Valsartan to be used by physicians for patients with heart failure as well as hypertension.
Valsartan was originally developed by U.S. pharmaceutical company Novartis and it was approved for use by the FDA in 1996. It was marketed under the brand name Diovan before losing patent protection and being marketed as a generic medication as valsartan. After its release, Valsartan quickly established itself as one of the most widely taken prescription drugs in the world in the competitive blood pressure medication marketplace. In 2010, just 4 years after its launch, global sales for the medication exceeded $6 billion. When the initial patent protection for Valsartan expired in 2012 a number of other pharmaceutical companies 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 2018, one of the leading manufacturers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, initially realized that the raw Valsartan it was producing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical production lab which manufactures valsartan and distributes it through U.S. channels Prinston, Huahi and Solco. The company manufactures the Valsartan component and wholesales it to major pharmaceutical companies globally who then use it to make, package and market their own generic versions of Valsartan. Zhejiang Huahai was by far the biggest wholesale producer of Valsartan component. 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). valsartan cancer of NDMA was entirely unexpected. The NDMA contamination was obviously possible from a change in the process of producing the medication that Zhejiang Huahai had adopted many years before.
The discovery created serious safety issues due to the known risks from NDMA. NDMA is a well-known leftover of certain chemical manufacturing procedurs. NDMA is classified as a carcinogen because it is known to cause cancer in humans. Numerous animal tests have established that exposure or ingestion of even minute amounts of NDMA may 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 due to concerns about environmental contamination. The EPA regards NDMA as a probable human carcinogen. NDMA is identified as a priority toxic pollutant in federal regulations.
After discovering the NDMA contamination, Zhejiang Huahai immediately notified pharmaceutical companies and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health officials to immediately recall all possibly contaminated versions of Valsartan. Since then, NDMA contamination has been found in the valsartan components produced by 2 other pharmaceutical suppliers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Lab testing on the components from these labs revealed lower levels of NDMA compared to the Zhejiang Huahai product.
The best manner to show how serious the problem with these contaminated medications is to show that there is wide support for further investigation in Congress. Congress cannot agree on the hue of the sky but are in agreement that they need additional information on what happened with Valsartan. Possible Injuries from Contaminated Valsartan NDMA is not only a particularly dangerous carcinogen, but it can also be a poison at high levels. There has been several reported issues in which people died from internal bleeding and severe liver damage after taking high doses of NDMA on just 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 a few months.
An investigation about the cause of the NDMA contamination has revealed that it was most likely created by an alteration in the production process that Zhejiang Huahai began several years ago. This means that Valsartan contaminated with NDMA was marketed for several years before discovery and recall. This is very disturbing because Valsartan is used as a maintenance drug which is taken daily on a continuing basis. This means that some people may have been taking NDMA once or twice a day for several years. This type of continuous long-term ingestion is specifically 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 global ingestion of Valsartan, the amount of patients who might develop cancer from exposure to NDMA is extremely large.
What Valsartan Users Need to Know If you’ve been taking Valsartan for treatment of hypertension or other issues, you should immediately consult with your prescribing physician regarding the possible dangers to your health. You should also determine what generic version of Valsartan you were receiving from your pharmacy. Not every generic versions of Valsartan were tainted with NDMA, although the list continues to grow as the research continues. In the United States the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.
What Amount of Money Can You Expect from a Valsartan Settlement? Of course, people want to know what the potential settlement value of the Valsartan case could be. It is a good question. The suffering patients might experience 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 understand more as the litigation progresses. A key to settlement value is to have lawyers that are going after every possible penny and are determined to maximize the amount of your case for all that you have had to live with either as a victim or surviving family member.
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