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Valsartan is a popular prescription drug used to control hypertension and various heart conditions. At the beginning of the year it was discovered that some ingredients used to produce Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. This data immediately pushed the FDA and European health officials to create worldwide safety recalls of the tainted Valsartan products.
Valsartan is an antihypertensive drug that is taken for the treatment of high blood pressure and for people with congestive heart issues. 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 creates constriction of the blood vessels promoting higher blood pressure. The mechanism made Valsartan more effective than similar medications before it that merely worked by stopping the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).
Valsartan proved to be very effective not only for patients with high blood pressure but additionally patients with congestive heart failure. In a study, Valsartan was compared with Captopril and another ACE inhibitor after a heart attack. The study determined that Valsartan was as effective as Captopril at keeping heart failure minimized.
An additional study 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 adjustment permitting Valsartan to be used by doctors for patients with heart failure as well as hypertension.
Valsartan was initially developed by American pharmaceutical giant Novartis and it was registered for use by the FDA in 1996. It was marketed under the brand name Diovan before losing patent protection and being sold as a generic drug as valsartan. After its release, Valsartan rapidly became one of the most commonly taken prescription drugs in the world 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 initial patent protection for Valsartan expired in 2012 a number of other pharmaceutical corporations 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 July 2018, one of the leading manufacturers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, initially realized 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. channels Prinston, Huahi and Solco. The company synthesizes the Valsartan component then distributes it to major pharmaceutical companies globally who then use it to manufacture, package and market their own generic variations of Valsartan. Zhejiang Huahai was by far the biggest wholesale manufacturer of Valsartan component. During 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 presence of NDMA was totally unexpected. The NDMA contamination was obviously possible from a change in the process of synthesizing the medication that Zhejiang Huahai had adopted many years earlier.
The discovery raised serious safety issues because of the known dangers of NDMA. NDMA is a well-known byproduct of certain chemical making processes. NDMA is named as a carcinogen because it is known to cause cancer in humans. Many animal tests have proven that exposure or ingestion of simply tiny amounts of NDMA may cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the manufacture of rocket fuel, however this use was halted because of 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 realizing the NDMA contamination, Zhejiang Huahai promptly alerted pharmaceutical companies and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health agencies to immediately recall any potentially contaminated versions of Valsartan. Since that time, NDMA contamination has been observed in the valsartan components made by 2 other pharmaceutical suppliers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Lab testing on the components from those labs revealed lower levels of NDMA in relation to the Zhejiang Huahai product.
The most effective way to highlight how dangerous the problem with these contaminated drugs is to show that there is bipartisan support for further investigation in Congress. These people can’t agree on the hue of the sky but they agree that they want more information on what happened with Valsartan.
Potential Injuries from Tainted Valsartan
NDMA is not merely a particularly dangerous carcinogen, but it can additionally be a poison at high levels. There has been valsartan colon cancer reported cases in which people died from internal bleeding and significant liver damage after taking high doses of NDMA on just one occasion. In animal testing, taking high to moderate levels of NDMA caused significant liver damage after just a few days and cancer after only a few months.
An investigation into the cause of the NDMA contamination has shown that it was most likely created by a change in the production method that Zhejiang Huahai started many years ago. This means that Valsartan tainted with NDMA was sold for many years before realization and recall. This is very troubling because Valsartan is used as a maintenance medication which is taken daily on a continuing manner. This means that some users may have been ingesting NDMA once or twice a day for several years. This sort of sustained long-term ingestion is exactly the type of exposure that might cause cancer. NDMA exposure is linked to specific cancers like:
Given the common ingestion of Valsartan, the amount of patients who could suffer from cancer from exposure to NDMA is extremely large.
What Valsartan Users Might Need to Know
If you’ve been taking Valsartan for treatment of hypertension or other conditions, 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 every generic versions of Valsartan were contaminated with NDMA, although the list continues to grow as the investigation proceeds. In the U.S. the safety recall only applied to the Valsartan made by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.
How Much Money Might You Anticipate from a Valsartan Settlement?
Of course, affected people want to understand what the possible settlement value of the Valsartan case can be. It’s a good question. The suffering patients could endure is significant and money compensation is all we have to strive to justice. The Valsartan lawsuits are just too recent to determine the possible settlement amount of these claims. We will learn more as the litigation continues. A note to settlement value is to have lawyers that are fighting for every potential dollar and are fighting to maximize the value of your case for everything that you have had to live with either as a victim or surviving family member.