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Valsartan Might Create Cancer

por Garrett Rigsby (2019-09-10)


Valsartan is a widely-used prescription medication taken to treat hypertension and other heart conditions. At the beginning of the year it was discovered that various ingredients used to make Valsartan had been contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to create cancer in humans. This data immediately pushed the FDA and European health agencies to issue global safety recalls of the contaminated Valsartan products.
About Valsartan
Valsartan is an antihypertensive drug that is used for the treatment of high blood pressure and for people with congestive heart problems. It’s also prescribed to people with ventricle dysfunction after experiencing 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 functionality made Valsartan more efficient than similar drugs before it that only 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 also people with congestive heart failure. In a recent study, Valsartan was measured against Captopril and another ACE inhibitor after a heart attack. The study determined that Valsartan was as effective as Captopril in keeping heart failure minimized.

An additional report found Valsartan minimized the risk of heart failure by some 20 percent measured against a placebo group. These results led the FDA to approve a label change permitting Valsartan to be used by doctors for patients with heart failure as well as hypertension.

Valsartan was originally created by U.S. pharmaceutical corporation Novartis and it was approved for use by the FDA in 1996. It was made available under the brand name Diovan before losing patent protection and being marketed as a generic medication as valsartan. Following its launch, Valsartan rapidly became one of the most commonly used prescription medications in the world in the competitive blood pressure medication marketplace. In 2010, only four years after its launch, worldwide sales for the drug exceeded $6 billion. When the original patent period for Valsartan expired in 2012 many other pharmaceutical brands started to make 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 manufacturer Zhejiang Huahai Pharmaceuticals, initially realized that the raw Valsartan it was manufacturing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing laboratory which makes valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company synthesizes the valsartan cancer [https://www.meneolawgroup.com/dangerous-drugs/valsartan/blog/] compound and wholesales it to large pharmaceutical companies around the world 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). The presence of NDMA was totally unexpected. The NDMA contamination was apparently possible from an alteration in the process of synthesizing the medication that Zhejiang Huahai had adopted many years earlier.

The discovery created serious safety concerns due to the known dangers of NDMA. NDMA is a well-known byproduct of certain chemical manufacturing processes. NDMA is reported as a carcinogen because it is known to cause cancer in humans. Numerous animal studies have determined that exposure or ingestion of simply tiny amounts of NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys. In the past NDMA was used in the production of rocket fuel, but this use was halted because of issues 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 alerted pharmaceutical brands and safety agencies. This prompted the U.S. Food and Drug Administration (FDA) and European health agencies to immediately recall all possibly affected versions of Valsartan. Since then, NDMA contamination has been observed 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 in relation to the Zhejiang Huahai product.

The best way to underscore how dangerous the problem with these contaminated medications is to show that there is wide support for continued investigation in Congress. These people cannot agree on the hue of the sky but they agree that they want more information on what happened with Valsartan.
Potential Injuries from Contaminated Valsartan
NDMA is not merely a very dangerous carcinogen, but it might also be a poison at high levels. There has been several reported issues 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 major liver damage after only a few days and cancer after only several weeks.

An investigation into the cause of the NDMA contamination has shown that it was probably caused by a change in the manufacturing process that Zhejiang Huahai started several years ago. This means that Valsartan tainted with NDMA was marketed for several years prior to observation and recall. This is highly troubling because Valsartan is used as a maintenance medication which is ingested daily on a continuing manner. This means that some users could have been ingesting NDMA once or twice a day for many years. This kind of continuous long-term use is specifically the kind of exposure that might 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 number of patients who might develop cancer from exposure to NDMA is extremely large.

What Valsartan Users Should to Know
If you’ve been taking Valsartan for symptoms of hypertension or other conditions, you can immediately consult with your prescribing physician about the possible dangers to your wellness. You should also find out what generic version of Valsartan you were receiving from your pharmacy. Not every generic versions of Valsartan were tainted with NDMA, although the list keeps growing as the investigation proceeds. In the U.S. 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, affected people want to know what the possible settlement value of the Valsartan case can be. It’s a valid question. The suffering users could experience is extreme and money compensation is all we have to reach to justice. The Valsartan lawsuits are simply too new to determine the possible settlement value of these claims. We’ll learn more as the litigation progresses. A note to settlement amount is to have lawyers who are fighting for every possible dollar and are fighting to maximize the amount of your case for everything that you have had to endure either as a victim or surviving family member.