Valsartan Lawsuit

fda recall of valsartan

Were you diagnosed with high blood pressure or hypertension and given a drug called Valsartan? If so, you could have been using a drug that was recalled due to contamination from a known carcinogen. Several studies have linked the drug to various types of cancers, and victims are coming forward to allege their cancer diagnosis is linked to using Valsartan.

Reach out to Join the Many today if you feel you are a victim in this type of case. No one should have to fight for their rights alone.

What is Valsartan?

valsartan lawsuit

Valsartan is a high blood pressure or hypertension drug. It is sold under brand names Diovan and Prexxartan in the U.S. It is also a component of several other drugs, including:

  • Diovan HCT (which includes valsartan and hydrochlorothiazide)
  • Exforge HCT (which includes amlodipine, valsartan, and hydrochlorothiazide)
  • Exforge (which contains amlodipine and valsartan)
  • Valturna (which contains Aliskiren and valsartan)

This prescription medication was first approved for use in 1996 after spending six years in development. It continues to be used and is considered safe to use in its current form.

Why is this medication used?

Doctors prescribe valsartan for those who have high blood pressure. It may also be used to treat some people with heart failure and to improve survival rates after a person experiences a heart attack. It works as an angiotensin II receptor antagonist. That means it works to block the specific action of natural substances that are located in the bloodstream that work to tighten up the function of the blood vessels. As a result of this, the drug allows for blood to flow through the heart smoother and with less complication. It also helps the heart to pump more efficiently, especially in those who have limited function due to heart failure or cardiomyopathy (as well as other conditions).

In addition to these conditions, valsartan is also FDA approved for the treatment of diabetic nephropathy or kidney failure or disease in people who have high blood pressure with it.

How is the medication taken?

The medication is typically sold as a tablet and taken daily. It may be taken one or two times a day based on the person’s prescription. It should not be skipped – even if you think you should not be taking it, work with your doctor to remove this drug from your needs, as suddenly stopping the use could lead to health complications.

Valsartan is often started slowly and built up over time. The drug also may require numerous adjustments before an optimal level is achieved. Those who have high blood pressure are at risk for damage to the heart if not lowered, which is why using this drug, according to your prescription, is critical.

How common is valsartan?

Valsartan is a very commonly used drug or an ingredient in other drugs. It is estimated that, in 2020, there were over 1.3 million people that were using the drug in the U.S.

It is safe to use this drug today. Keep in mind that if you used this drug from 2012 through 2018, though, you should verify that you were not exposed to contamination. If you developed cancer after taking Valsartan during that period, reach out to Join the Many now. You could be entitled to financial compensation for your losses.

Medications That Included Valsartan

Medications That Included Valsartan

You should have up-to-date information about Valsartan if you used these drugs under any of the following names:

  • Diovan
  • Entresto
  • Exforge
  • Byvalson
  • Valturna

Some of these drugs are still in production and considered safe to use if they are a newer prescription written after 2019. Do not take medications outside of that date range without speaking to your doctor about doing so.

FDA Recall of Valsartan

FDA Recall of Valsartan

In 2018, the U.S. Food and Drug Administration (FDA) announced a recall of Valsartan. The FDA announced that there was a voluntary recall of drugs containing valsartan as an active ingredient on July 13, 2018. At that time, the FDA stated that the drug was found to have an impurity within it called N-nitrosodimethylamine (NDMA). This is a known carcinogen, which means it is a chemical that is known to cause cancer in people and animals.

This recall did not include all products that contain Valsartan but rather just a set number of batches that were produced by specific manufacturers. The presence of NDMA is not expected and should not be included in any medications, thus leading to the recall. At that time, the FDA believed the presence of NDMA was due to a change in the manufacturing process. Prior to this, the FDA had approved the manufacturing process of Valsartan in 2012. Therefore, sometime between that approval in 2012, which did not allow for the presence of NDMA, and when the contamination was discovered in July of 2018, a change occurred that put people at risk.

Additional recalls were issued

The FDA reported, along with the European Medicines Agency (EMA), that the NDMA was found in products produced by Zhejiang Huahai Pharmaceutical Co (ZHP) in China. This manufacturer produced the main bulk ingredient in Valsartan. It then shipped that product to other manufacturers to complete the production of the tablets taken.

The initial recall of Valsartan was not the last. Its initial recall involved manufacturers Solco Healthcare LLC, Teva Pharmaceutical Industries, and Major Pharmaceuticals. On August 2, 2018, the FDA sighted two additional manufacturers, Zhejiang Tianyu Pharmaceuticals of China and Hetero Labs Limited from India as well.

In September 2018, the FDA announced that another contamination was found, this time with the impurity N-Nitrosodiethylamine (NDEA). This is another known carcinogen. It was made by ZHP and then marketed in the U.S. as the Torrent Pharmaceuticals brand. There were additional contaminations found in 2019 of NDMA.

You can find the specific recalled medication lots on the FDA’s website. There are hundreds of them. It may be hard to know that you were taking the medication that was recalled. You may be able to find records through your pharmacy from the period of 2012 through 2018 that include the lot number, National Drug Code, or other data. You can check that information against this list.

What Are the Risks of Taking the Valsartan That Was Recalled?

What Are the Risks of Taking the Valsartan That Was Recalled?

Many people were taking this drug at the time of the recall. When the recall was issued, pharmacies should have contacted people who were using the drug and provided an alternative option. There are some manufacturers of Valsartan that have not had any contamination issues. If you are taking medications from another provider, you are not at risk.

Those who did take this medication during the period and were found to be taking the contaminated medication could be at an increased risk of developing some types of cancers. Some of the cancers that NDMA has been linked to in people or animals include:

  • Colorectal cancer
  • Prostate cancer
  • Non-Hodgkin’s lymphoma
  • Leukemia
  • Esophageal cancer
  • Gastric cancers
  • Liver cancers
  • Pancreatic cancer

Keep in mind that cancer is not an expected side effect of taking this drug. If you did not have other risk factors and developed one of these or other cancers as a result of your use of the drug, take action.

Join the Many can help you. If you have a qualifying case, we’ll carefully match you with attorneys who specialize in cases like yours and they will begin working for you right away. 

Which Manufacturers Are Impacted?

If you were taking this medication during that period and are unsure if the medication was one of the recalls, consider the manufacturers. The following are the manufacturers and medications that were recalled:

  • Teva Pharmaceuticals labeled as Major Pharmaceuticals
  • Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC
  • Teva Pharmaceuticals USA labeled as Actavis, AvKARE (Teva/Actavis), RemedyRepack Inc. (Prinston/Solco)
  • A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco),
  • Bryant Ranch Prepack Inc. (Teva/Actavis)
  • H J Harkins Company Inc. dba Pharma Pac (Prinston/Solco)
  • Northwind Pharmaceuticals (Teva/Actavis)
  • Hetero Labs, Inc. labeled as Camber Pharmaceuticals, Inc.
  • NuCare Pharmaceuticals Inc. (Prinston/Solco)
  • RemedyRepack, Inc. (Hetero/Camber)
  • AvKARE (Hetero/Camber)
  • Preferred Pharmaceuticals,  Inc. (Hetero/Camber)
  • Torrent Pharmaceuticals Limited, and RemedyRepack, Inc. (Torrent)

Doctor Sentiment About Valsartan

Overall, people who are taking this drug should not stop taking it without working with their doctor. Doctors believe it is beneficial and safe to use (the FDA has approved its continued use).

In a report regarding the case with CNN, Dr. Suzanne Steinbaum, who works at Mount Sinai in New York as the Director of Women’s Cardiovascular Prevention, stated, “Their biggest concern is about their risk of cancer and better understanding how concerned they should be.” She was talking about patients who were taking the medication and unsure what they should do.

She continued, “They are asking if there is any testing that should be done. Patients are now asking if they should only request ‘brand name” medications instead of generic in order to make sure that this doesn’t happen. Lastly, they all want to stop the medication.” She notes that this is not the best action to take.

When it comes to Valsartan, there are many legal proceedings taking place, though there have not been any awards of settlements just yet. Here is what you need to know.

In 2019, a panel was created by the federal government to oversee the numerous cases of loss that were being brought into district courts. This allowed for the recreation of mass litigation against about 20 manufacturers for the contamination. Since that initial panel was created (which only had about 10 lawsuits at the time), more than 20 to 30 additional claims were made in the coming year. To date, as of July 2022, more than 1,050 claims have now been made. That means that there are hundreds of people that are likely to still have a claim against the company for this drug’s use.

The claims include claims that improper testing was done by manufacturers and that a failure occurred in providing a safe product. There has not been a statement made from the companies yet about the claims because they are pending legislation.

It is expected that by late 2022 to mid 2023, there will be the initial cases being heard by district courts. These cases will likely set the precedent for what is to come during the following cases against the manufacturers involved.

There are still many people reporting their exposure and the development of cancers or other ailments from it. If they are found to be responsible for the contamination, it could mean that people are owed money for the losses they have incurred as a result of those claims. 

What Should You Do If You Were At Risk

If you took valsartan or any other drug that contained this substance, and did so between 2012 and 2018, Join the Many. Our team is helping connect people who could be victims to legal experts who can ensure the justice system works in their favor and level the playing field against giant pharmaceutical companies.

If you have developed complications from your use of this drug, specifically in relation to the development of cancer, it is critical that you reach out to us immediately for help. 

Your legal battle will not be fought alone. We will guide you every step of the way and carefully match you with legal experts who will build and fight your case from start to finish.

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