Valsartan Can Create Cancer
Valsartan is a popular prescription medication taken to treat hypertension and various heart issues. At the beginning of the year it was observed that certain 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 agencies to submit worldwide safety recalls of the tainted Valsartan products.
Valsartan is an antihypertensive drug that is taken for controling high blood pressure as well as for people with congestive heart issues. It’s also prescribed to patients 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. valsartan cancer made Valsartan more efficient 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 highly effective not only for patients with high blood pressure but also people with congestive heart failure. In a recent 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.
Yet another study found Valsartan minimized the risk of heart failure by approximately 20 percent measured against a placebo group. These results motivated the FDA to approve a label change permitting Valsartan to be prescribed by doctors for people with heart failure in addition to hypertension.
Valsartan was initially developed by American pharmaceutical company Novartis and it was approved for use by the FDA in 1996. It was made available under the brand name Diovan prior to losing patent protection and then sold as a generic drug as valsartan. Following its launch, Valsartan rapidly became one of the most commonly taken prescription drugs in the world in the competitive blood pressure drug marketplace. In 2010, just four years after its launch, global revenue for the medication exceeded $6 billion. When the initial patent period for Valsartan expired in 2012 a number of other pharmaceutical corporations started to make generic versions of the drug. The biggest generic manufacturers of Valsartan were Teva Pharmaceuticals Industries Ltd. and Solco Healthcare Inc.
Contamination of Valsartan with NDMA
In 2018, one of the leading makers of generic valsartan, the Chinese manufacturer Zhejiang Huahai Pharmaceuticals, initially discovered that the raw Valsartan it was producing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing lab which manufactures valsartan and sells it through U.S. channels Prinston, Huahi and Solco. The company manufactures the Valsartan compound and distributes it to large 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 biggest wholesale producer 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 appearance of NDMA was totally unexpected. The NDMA contamination was apparently caused by a change in the process of making the drug that Zhejiang Huahai had adopted several years before.
The realization raised significant safety concerns because of the known dangers of NDMA. NDMA is a well-known byproduct of certain chemical manufacturing processes. 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 simply small amounts of NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys. In the past NDMA was used in the manufacturing of rocket fuel, but this use was halted due to concerns 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 agencies. This prompted the U.S. Food and Drug Administration (FDA) and European health officials to immediately recall any potentially contaminated versions of Valsartan. Since then, NDMA contamination has been found in the valsartan components made by two other pharmaceutical suppliers: 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 way to highlight how serious the problem with these contaminated drugs is to show that there is wide support for continued investigation in Congress. Congress cannot agree on the hue of the sky but are in agreement that they want additional information on what occurred with Valsartan.
Potential Injuries from Tainted Valsartan
NDMA is not merely a particularly dangerous carcinogen, but it might 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 taking high doses of NDMA on just one occasion. In animal testing, taking high to moderate amounts of NDMA caused major liver damage after only a few days and cancer after only a few months.
An investigation into the cause of the NDMA contamination has revealed that it was probably created by an alteration in the manufacturing process that Zhejiang Huahai began many years ago. This means that Valsartan tainted with NDMA was sold for many years prior to discovery and recall. This is extremely troubling because Valsartan is used as a maintenance medication which is ingested daily on a continuing basis. This means that some patients might have been ingesting NDMA once or twice a day for several years. This type of sustained long-term use is specifically the type of exposure that may cause cancer. NDMA exposure is linked to specific cancers such as:
Given the global ingestion of Valsartan, the amount of people who could suffer from cancer from exposure to NDMA is extremely large.
What Valsartan Users Might Need to Know
If you have been taking Valsartan for symptoms of hypertension or other issues, you can immediately consult with your prescribing doctor about the potential dangers to your wellness. You should also find out what generic version of Valsartan you were getting from your pharmacy. Not all generic versions of Valsartan were tainted with NDMA, although the list keeps growing as the research proceeds. In the U.S. the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.
How Much Money May You Anticipate from a Valsartan Settlement?
Of course, affected people want to know what the possible settlement amount of the Valsartan case can be. It’s a good question. The suffering users may endure is significant and money compensation is all we have to reach to justice. The Valsartan lawsuits are just too new to gauge the possible settlement value of these claims. We will understand more as the litigation progresses. One note to settlement value is to have lawyers who are going after every potential dollar and are determined to maximize the value of your case for all that you have had to live with either as a victim or surviving family member.