Valsartan is a widely-used prescription medication taken to treat hypertension and other heart conditions. At the beginning of the year it was observed that various ingredients used to manufacture Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. This information immediately prompted the FDA and European health officials to issue global safety recalls of the contaminated Valsartan products. About Valsartan Valsartan is an antihypertensive medication that is used for controling high blood pressure as well as for people with congestive heart problems. It is also prescribed to patients 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. This functionality made Valsartan more efficient than similar drugs before it that merely worked by blocked 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 also people with congestive heart failure. In a recent study, Valsartan was measured against Captopril and another ACE inhibitor after a heart attack. The research found that Valsartan was as effective as Captopril at keeping heart failure minimized.
Another study found Valsartan minimized the risk of heart failure by some twenty percent compared to a placebo group. These results motivated the FDA to approve a label adjustment allowing Valsartan to be used by physicians for people with heart failure in addition to hypertension.
Valsartan was originally developed 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 medication as valsartan. After its release, Valsartan quickly became one of the most commonly used prescription medications globally in the competitive blood pressure drug market. In 2010, just four years after its launch, global sales for the drug surpassed $6 billion. When the original patent protection for Valsartan expired in 2012 many other pharmaceutical companies began making 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 July 2018, one of the leading manufacturers of generic valsartan, the Chinese manufacturer Zhejiang Huahai Pharmaceuticals, first realized that the raw Valsartan it was manufacturing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical production lab which manufactures valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company manufactures the Valsartan compound then distributes it to large pharmaceutical companies around the world who then use it to make, package and sell their own generic variations of Valsartan. Zhejiang Huahai was by far the biggest wholesale manufacturer of Valsartan compound. During 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 totally unexpected. The NDMA contamination was apparently caused by an alteration in the process of making the medication that Zhejiang Huahai had adopted many years earlier.
The discovery created serious safety issues because of the known dangers of NDMA. NDMA is a well-known leftover of certain chemical manufacturing processes. NDMA is named as a carcinogen because it is known to cause cancer in humans. Many animal tests have established that exposure or ingestion of simply small amounts of NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the manufacturing of rocket fuel, but this use was halted due to concerns regarding environmental contamination. The EPA classifies NDMA as a probable human carcinogen. NDMA is identified as a priority toxic pollutant in federal regulations.
After realizing the NDMA contamination, Zhejiang Huahai promptly 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 then, NDMA contamination has been observed in the valsartan components made by two other pharmaceutical wholesalers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Lab testing on the components from those labs showed lower amounts of NDMA in relation to the Zhejiang Huahai product.
The most effective manner to state how serious the issue with these contaminated medications is to point out that there is bipartisan support for further investigation in Congress. Congress cannot agree on the color of the sky but are in agreement that they need more information on what happened with Valsartan. Potential Injuries from Contaminated Valsartan NDMA is not merely a very dangerous carcinogen, but it can additionally 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 merely one occasion. In animal testing, taking high to moderate levels of NDMA caused significant 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 probably caused by a change in the production method that Zhejiang Huahai started several years ago. This means that Valsartan tainted with NDMA was sold for several years before realization and recall. This is very disturbing 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 type of sustained long-term use is specifically the type of exposure that can cause cancer. NDMA exposure is linked to specific cancers such as: Liver Cancer Gastric Cancer Colorectal Cancer Kidney Cancer
Given the widespread ingestion of Valsartan, the amount of people who could develop cancer from exposure to NDMA is extremely large.
What Valsartan Users Might Need to Realize If you’ve been taking Valsartan for symptoms of hypertension or other issues, you should immediately consult with your prescribing doctor regarding the possible dangers to your health. You should also find out what generic version of Valsartan you were receiving 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 manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.
How Much Money Can You Expect from a Valsartan Settlement? Understandably, patients would like to understand what the potential settlement value of the Valsartan case might be. It’s a great question. The suffering victims could experience is extreme and money compensation is all we have to strive towards justice. The Valsartan lawsuits are just too new to observe the potential settlement value of these claims. We’ll learn more as the litigation continues. A key to settlement value is to have lawyers that are going after every possible dollar and are determined to maximize the amount of your case for everything that you have had to endure either as a victim or surviving family member.
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