NDMA is a known carcinogen, which means it is known to cause cancer. If you were taking this drug, specifically the contaminated batches, and you developed cancer in recent years, it is critical that you learn about your rights. You may be entitled to financial compensation for your losses.
History of Valsartan
Valsartan is not a new drug, having been used throughout the world as a treatment for high blood pressure. It is called an angiotensin-receptor blocker. That means it works on its own or with other medications to manage health conditions related to blood pressure in people who have heart failure or those who are unable to tolerate other types of ACE inhibitors. The drug can also be used to treat diabetic kidney disease in some people.
These drugs are considered a reasonable treatment for high blood pressure, though many people feel side effects such as diarrhea, joint pain, dizziness, or feeling tired.
The drug was first patented in 1990, though it took until 1996 to receive approval for use by the FDA and European health administrations. Throughout much of its use, this drug has been seen as a very positive treatment with few or limited side effects, often helping people to see a significant number of improvements in function.
If you were one of the many who did suffer from complications related to cancer after taking this drug, Join the Many can help you find out if you qualify for compensation.
Research Findings for Valsartan
Though the drug is still being used readily, there have been some concerns that led to a recall of the drug in 2018. Initially, the European Medicine Agency (EMA) launched a recall of specific batches of the drug in 22 countries spanning all of Europe. This occurred on July 6, 2018. The recall included drugs:
- Valsartan (used on its own)
- Valsartan and hydrochlorothiazide combinations
The EMA found that the manufacturer, Zhejiang Huahai Pharmaceutical Co., which is located in Linhai, China, produced this medication using NDMA. This manufacturer produced the bulk active ingredient in Valsartan. That material was then shipped to various other drugmakers who used it to produce the tablets that consumers took. That includes generic drugmaker Novartis. That batch of the drug was marketed in Asia and Europe under the Sandoz label. In the U.K., it was marked by Dexcel Pharma LTD as well as Accord Healthcare.
On July 12, 2018, The National Agency of Drug and Food Control voluntarily recalled two medications that were produced by Dipa Pharmalab Intersains and Actavis Indonesia as a result of the allegations. The next day, the U.S. Food and Drug Administration (FDA) announced the recall of some supplies of the two drugs that were produced by Solco Healthcare LLC, Teva Pharmaceutical Industries, and Major Pharmaceuticals. Several other health agencies throughout the world also took action.
In the U.S., the FDA published two very long lists of specific products that contained valsartan that were considered safe and excluded from the actual voluntary recall by the producers in the U.S. In addition to this, the FDA further cited two other manufacturers as being sources for the contamination – Zheijang Tianyu Pharmaceuticals (ZHP) of China as well as Hetero Labs Limited of India.
Unfortunately, the problem did not stop there.
In September 2018, the FDA also announced that a retesting of all of the products containing valsartan in the U.S. found the secondary carcinogen presence, N-nitrosodiethylamine (NDEA). This is a second drug that is known as a risk factor for cancer. As a result of this investigation, the U.S. recalled products made by ZHP as well as Torrent Pharmaceuticals, the same Indian brand with different branding in the U.S.
There have been over 50 companies throughout the U.S. and around the world that have faced a recall of valsartan drugs because of the contamination. Some research indicates that this contamination could have been present much earlier than the recall date, even dating back to 2012. That is when the FDA and EDM approved the manufacturing processes presented. As a result of the claims, both organizations took steps to suspend the Indian and Chinese manufacturers’ certificates of suitability.
Another recall occurred in 2019. At that time, there were more cases of contamination of the drug with NDMA found, likely from the same manufacturers.
Further to the frustration of patients who had become dependent on the drug, there was a shortage of the medication as a result of the recall. This includes a shortage of losartan, valsartan, as well as irbesartan medications, all of which contain the same bulk ingredient.
As a result of that shortage, the FDA pushed through the approval of a new drug, a generic version of valsartan, called Diovan. It is believed that all shortages were resolved in the year following that approval.
There is a risk to people who took this drug with the known carcinogens. As a result of that exposure, many people throughout the U.S. and elsewhere have come forward with claims of cancer development and other complications due to their exposure to NDMN or NDEA.
Valsartan is a commonly used drug, and while not everyone taking it was exposed to these risk factors and the contamination, many people have come forward with claims of personal loss as a result of those interactions.
These individuals have claims, including the development of cancer – which is not a typical side effect of the use of valsartan and should not be considered an expected outcome of the use of this drug. However, NDMA specifically has led to the development of cancer in people and animals, with significant instances reported of it.
Class Action Lawsuits Are in Place for Valsartan
Beginning nearly right away, many people reported their exposure and risks associated with valsartan to attorneys who began the process of filing lawsuits against the manufacturers as a result of their clients’ exposure. In February 2019, there were so many such claims that a federal panel was created, which ultimately combined 10 lawsuits from around the U.S. into a single mass litigation. This is currently in place in a New Jersey Federal Court.
Since that initial creation, there have been upwards of 30 or more claims that are likely to be added to the initial mass litigation case.
The lawsuits, in this case, are numerous. Because so many companies purchased and used the bulk material manufactured in China and did not properly test it for purity or any other results, there are about 20 manufacturers that are labeled as defendants in these cases.
Over the course of the last few years, these claims have grown substantially. This may be due to more people being impacted or learning about the risk of their contamination. As of July 2022, more than 1000 such claims have been brought against the manufacturers of the drug. There may be more.
Should You Take Action?
If you are unsure if you are a victim of this type of contamination, we can get you the answers you need. If you have a qualifying case, we’ll carefully match you with the best legal experts available to fight on your behalf.
Have there been Settlements in Valsartan Claims?
Unfortunately, there have not been any settlements reached as of yet with the manufacturers of the drug for the claims made against them. This is not uncommon, though. Many of these cases are still coming in, and as such, the courts are waiting until as many people as possible with such claims take a step forward.
It is expected that the Valsartan cases will start trial phases in district court between 2022 and 2023. These will be the very first trials in this type of case, and as such, they are likely to be some of the most important in determining what steps are next for others suffering from these losses.
That is why it is so important for you to take action right now if you think you could have suffered as a result of this contamination. Join the Many can help you be among the first to stand up against negligence and demand accountability.
What Type of Claims Are Being Made?
If you have any type of cancer that developed after you began taking Valsartan, act now. Studies have linked NDMA with a wide range of cancers, including:
- Colorectal cancer
- Prostate cancer
- Non-Hodgkin’s lymphoma
- Esophageal cancer
- Gastric cancers
- Liver cancers
- Pancreatic cancer
Some people also had symptoms of illness after taking the drug. It is known that NDMA can cause symptoms such as:
- An enlarged liver
- Liver fibrosis
- Stomach cramping
- Lung damage
- Liver and kidney damage
While not everyone taking these drugs have these negative experiences, if you could have, and you believe that your cancer is due to your use of this drug, reach out to Join the Many to find out more.
Which Types of Generic Valsartan Was Recalled?
Keep in mind that you may not have been taking valsartan directly. The drug is used in a wide range of other medications and manufactured through numerous organizations.
To find out if you were taking the drugs that were recalled, go to the FDA website, where the most up to date list is provided. This will list not just the medications but the dosing, lot numbers, and expirations.
Should You Keep Taking Valsartan?
Do not stop taking this medication without first talking to your doctor. Doing so could cause additional side effects and complications for your health.
Note that there are manufacturers of the drug that have not been implicated in the recall. That includes medications made by Alkem Laboratories Ltd. In addition to this, the FDA turned to generic manufacturer Novartis to manufacturer Diovan, its version of the drug. This drug is being made and is considered safe by the FDA.
If you are taking other medications that contain valsartan, including Entresto, Exforge, or Byvalson, continue to take them as directed to do so by your doctor. You are not at risk as long as you are using the most recent medications and not old or expired medications.
What Can You Do Now if You’re at Risk?
Many thousands of people have taken valsartan, and its use around the globe continues to grow because of its effectiveness. While this contamination does not impact all of the companies making it, it is very important for you to consider if you were taking this drug from 2012 to 2018 and, if so, if your medication was one of those recalled.
If that is the case, and you develop cancer after doing so, immediately contact Join the Many. Our team will work closely with you to gather information about your case and help you to become one of the many that are working on getting financial compensation owed to them as a result of this exposure.