Valsartan is a popular prescription drug used to treat hypertension and other heart conditions. Earlier this year it was discovered that certain ingredients used to manufacture Valsartan were 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 drug that is used for the treatment of high blood pressure and for people with congestive heart problems. It is also prescribed to individuals 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 mechanism made Valsartan more effective than similar drugs before it that only 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 people with high blood pressure but also people with congestive heart failure. In one study, Valsartan was compared with Captopril and another ACE inhibitor after a heart attack. The study found that the Valsartan was as effective as Captopril in keeping heart failure at bay.
Another study found Valsartan reduced the risk of heart failure by some 20 percent compared to a placebo group. These results led the FDA to approve a label change allowing Valsartan to be prescribed by physicians for patients with heart failure as well as hypertension.
Valsartan was originally developed by U.S. pharmaceutical giant Novartis and it was approved for use by the FDA in 1996. It was sold under the brand name Diovan before losing patent protection and being marketed as a generic as valsartan. Following its release, Valsartan quickly became one of the most widely used prescription drugs in the world in the competitive blood pressure medication market. In 2010, just 4 years after its release, global sales for the drug exceeded $6 billion. When the original 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 July 2018, one of the leading manufacturers of generic valsartan, the Chinese company Zhejiang Huahai Pharmaceuticals, first discovered that the raw Valsartan it was producing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical production lab that manufactures valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company synthesizes the Valsartan compound and wholesales it to major pharmaceutical companies around the world who then use it to manufacture, package and sell their own generic versions of Valsartan. Zhejiang Huahai was by far the largest wholesale producer of Valsartan compound. Sometime in 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 caused by a change in the method of synthesizing the drug that Zhejiang Huahai had adopted several years earlier.
The discovery raised serious 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 studies have established that exposure or ingestion of even small amounts of NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the manufacture of rocket fuel, but this use was stopped because of concerns about environmental contamination. The EPA classifies 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 companies and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health officials to immediately recall all potentially affected versions of Valsartan. Since then, NDMA contamination has been found in the valsartan components produced by 2 other pharmaceutical wholesalers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from these labs showed lower levels of NDMA compared to the Zhejiang Huahai product.Potential Injuries from Contaminated Valsartan
NDMA is not only a particularly dangerous carcinogen, but it can also be a poison at high levels. There have been several reported cases in which people died from internal bleeding and severe liver damage after ingesting high doses of NDMA on just one occasion. In animal testing, ingesting high to moderate levels of NDMA caused major liver damage after just a few days and cancer after just several weeks. Almost all of the animals
An investigation into the cause of the NDMA contamination has shown that it was most likely caused by a change in the manufacturing process that Zhejiang Huahai started several years ago. This means that Valsartan contaminated with NDMA was on the market for several years before discovery and recall. This is very troubling because Valsartan is used as a "maintenance" drug which is taken daily on a long-term basis. This means that some people may have been ingesting NDMA once or twice a day for several years. This sort of continuous long-term use is exactly 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 use of Valsartan, the number of people who may develop cancer from exposure to NDMA is very large.What Valsartan Patients Need to Know
If you have been taking Valsartan for treatment of hypertension or other conditions, you should immediately consult with your prescribing doctor about the potential dangers to your health. You should also find out what generic version of Valsartan you were getting from your pharmacy. Not all 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 manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.How Much Money Can You Expect from a Valsartan Settlement?
Understandably, people want to know what the possible settlement value of the Valsartan case might be. It is a good question. The suffering victims may endure is extreme and money compensation is all we have to reach towards justice. Our law firm has been willing to go out on a limb to predict the values of mass tort cases in their early stages. But the Valsartan lawsuits are just too new to gauge the potential settlement value of these claims. To get some idea of the trial value of cancer cases, you can find sample settlement and verdicts here that are based on the type of cancer the person has. Is this kind of data helpful to victims? Sure. But, ultimately, these Valsartan lawsuits are new and we really do not know what the possible settlement value of Valsartan claims might be. We will learn more as the litigation progresses. One key to settlement value is to have lawyers who are fighting for every possible penny and are determined to maximize the value of your case for all that you have had to endure either as a victim or surviving family member.Contact Miller & Zois About Valsartan
If you are one of the thousands of people that have been taking Valsartan to treat high blood pressure or other conditions, you may have been injured by the NDMA contamination. Thousands of lawsuits will likely be filed over the Valsartan contamination. If you think you may have been harm by contaminated batches of the drug, contact the attorneys at Miller & Zois today. We can help investigate your case and determine whether you might have a valid claim. Call us at 800-553-8082 today or get a free online consultation.
What kinds of Valsartan cases are we reviewing? First, the contamination likely began in 2015 so we are looking for at least a year of use before receiving a cancer diagnosis.
The cancer cases we are looking for are liver, stomach, or colorectal cancer. The early evidence is that these cancers are associated with Valsartan. At this time, we are not reviewing bladder, kidney cancer, or pancreatic cancer cases because the evidence is not there, at least not yet.
We are also reviewing liver injury cases. The criteria here is if you have at least three days of hospitalization that occurred within 30 days of taking the drug.