Valsartan Lawsuit | Hypertension Drug Recall

When did the High Blood Pressure Medication Recall Begin?

On July 13, 2018, the U.S. Food and Drug Administration issued a press release about voluntary recalls of several drug products containing the ingredient Valsartan. The recall came on the heels of the agency finding a carcinogenic impurity, NDMA in the ingredient. At the time, the FDA warned that the chemical might have been in valsartan-containing drugs for as many as four years. In the initial release, the FDA was very clear that not all products containing valsartan were under recall. The recall was confined to products manufactured in Zhejiang Huahai Pharmaceuticals in Linhai, China.

However, as the FDA continued to investigate the valsartan impurity, more high blood pressure drugs were recalled. The latest high blood pressure drug recall expansion occurred in March 2019.

What is Valsartan?

Valsartan is a generic prescription antihypertension drug used to treat high blood pressure and heart failure. These hypertension drugs contain an active ingredient bearing the same name – Valsartan. In those with heart failure, the drug lowers the chance of having to go to the hospital for heart failure. The drug belongs to a class of drugs called angiotensin receptor blockers (ARBs).

The drug works by relaxing blood pressure vessels to that the blood can flow easily.

Doctors prescribe the drug to adults and children who are at least six years old. Sometimes the drugs are given in combination with other blood pressure medications.

Why is there a Valsartan Lawsuit?

A lawsuit against valsartan makers exists because of cancerous impurities within the drug. Through the manufacturing process, valsartan becomes contaminated with a substance called nitrosamines.

In the summer of 2018, a voluntary recall from three companies recalled products containing valsartan. Major pharmaceuticals, Solco Healthcare, and Texas Pharmaceutical Industries recalled the drug after the FDA found an impurity that poses a potential cancer risk. Upon facility inspection and testing, the FDA found that a change in the manufacturing process of Valsartan led to the formation of N-Nitrodoimethylamine (NDMA). As a result, the companies issued the recalls at the FDA’s request.

Eventually, the Valsartan recall spread to include other drugs. As of March 2019, almost 90 drugs are part of the high blood pressure medication recall.

If you or a loved one received a cancer diagnosis after taking valsartan, contact The Carlson Law Firm. We can help you decide if filing a valsartan recall lawsuit is the right step for you.

Is Valsartan carcinogenic?

Yes. Valsartan contains N-Nitrodoimethylamine (NDMA), a carcinogenic substance that research links to several types of cancer. While some agencies warn that there is little concern for those taking the drug developing cancer, that is not true. Hundreds have already begun looking to taking action against major drug companies for cancer diagnosis, as well as failure to alert the public on the dangers of these drugs.

Given the FDA’ belief that NDMA has been present in the drug since at least 2012, as a result of manufacturing changes, it is possible for heart and hypertensive patients to have been unknowingly ingesting the carcinogen for at least six years.

What other side effects are associated with Valsartan?

In addition to cancer, valsartan is linked to the following risks:

• Liver failure
• Kidney failure
• Lowered white blood cell count
• Swelling in certain tissues in the body

Additionally, valsartan is linked to birth defects.

Which Impurities Were Found in High Blood Pressure Medications?

By definition, an impurity is something that ruins the uncontaminated nature of something. There are good impurities and bad impurities. An example of a good impurity is adding lemons and sugar to water to make lemonade. On the other hand, the nitrosamine impurities found in high blood pressure medication are unwanted.

What are Nitrosamines?

Generally, nitrosamine compounds are chemical compounds from the nitroso group bonded to an amine. Most of these compounds are carcinogenic.

The manufacture of cosmetics, pesticides and most products made from rubber often include nitrosamine as an ingredient. Nitrosamines can form unintentionally. For example, when nitrosamines occur in food, it is typically from high temperatures such as frying, which enhances the formation of nitrosamines. Nitrosamines occur in beer, fish, meat and cheese products, as well as tobacco products.

The nitrosamine compounds found in valsartan are carcinogenic. Experts believe that these chemicals are an unintended byproduct of the manufacturing process. Since finding NDMA in valsartan, the FDA has continued to oversee a major investigation in high blood pressure medication impurities. In addition to NDMA, this investigation has found two other nitrosamine impurities in hypertension medications.

NDMA

N-Nitrodoimethylamine is a human carcinogen that the hypertension drug valsartan unintentionally contains. The organic chemical forms in both industrial and natural processes. In fact, the chemical is an ingredient in liquid rocket fuel, softeners, lubricants, and several other products. The unintentional creation of NDMA can occur through specific chemical reactions. It is often the byproduct of pesticide and tire manufacturing, as well as fish processing.

So far, studies have linked NDMA to the following:

• Liver cancer
• Kidney cancer
• Colorectal cancer
• Stomach cancer

Additionally, according to the Environmental Protection Agency, high-level NDMA exposure in humans causes liver damage in humans.

NDEA

NDEA is a carcinogenic organic compound impurity found in high blood pressure drugs. It has the ability has to alter an organism’s DNA. These mutations often cause cancer. The substance is found in tobacco smoke. The World Health Organization classifies the compound as a Group 2A carcinogen.

Similarly to NDMA, NDEA is toxic to the liver and other organs. Researchers have found that NDEA causes severe injury to the liver and red blood cells in rats. These injuries can lead to liver damage and liver cancer.

NMBA

NMBA is the second potentially cancer-causing impurity found in hypertension medications. Much like most nitrosamines, NMBA occurs naturally in foods, drinking water, and air pollution. It can also be a byproduct in industrial processes. Further, the International Agency for Research on Cancer classifies NDMA as a probable human carcinogen.

Which Drugs Are Included in the High Blood Pressure Recall Expansion?

Several drugs are now part of the high blood pressure medication recall. Further, several companies pulled hundreds of lots containing valsartan, losartan, and irbesartan from shelves.

As of March 19, 2019, the FDA lists pharmaceutical companies with valsartan products under recall as the following:

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

The FDA provides specific lots and expiration dates.

Which Medications Treat High Blood Pressure?

Valsartan is an angiotensin II receptor blocker. However, there are several other drugs to treat high blood pressure. Depending on your specific conditions, high blood pressure medications include the following:

• Diuretics
• Beta-blockers
• ACE inhibitors
• Calcium channel blockers
• Alpha-blockers
• Alpha-2 receptor agonists
• Combined alpha and beta-blockers
• Central agonists
• Peripheral adrenergic inhibitors
• Vasodilators

These drugs do everything from help the body get rid of excess sodium and water to reducing the heart’s workload and output of blood. Also, many of these drugs work by relaxing the blood vessels to lower blood pressure.

What Should I do with my Valsartan Medications?

It is no secret that prescribed medication have negative consequences for all patients. The carcinogenic chemicals found in valsartan at an increased risk for certain cancers and liver damage. If you take heart medication, the FDA advises several steps if you take one of the recalled medications.

• First, don’t just stop taking your medication. High blood pressure medications treat extremely serious conditions.
• Next, consult the FDA’s recall list to see if your medication is on the list of recalled drugs.
• Finally, if your medication is on the list, do not stop taking your medication until you speak with your doctor. Your doctor will help you find a replacement medication or alternative treatment.

If you or a loved one are living with liver damage or a cancer diagnosis after taking a valsartan, contact us. We have a valsartan recall lawsuit attorney ready to take your call.

Should I hire a Valsartan Lawyer to represent me in my claim?

When you are dealing with cancer that is caused by the negligence of a large corporation, you need knowledgeable legal representation. Further, if you believe that you can file a claim against Valsartan manufacturers alone, you will likely lose out on compensation or get an unfair settlement. A Valsartan lawyer can help you successfully recover the following damages through a lawsuit:

• Medical bills
• Pain and suffering
• Lost wages
• Financial losses as a result of your diangosis
• Funeral expenses for a loved one’s death

Drug corporations are multi-billion-dollar businesses. As such, they have a team of lawyers working to deny your injuries and illnesses were the result of their negligence. The Carlson Law Firm has the resources, experience and knowledge to represent you in your claims against Valsartan manufacturers.

Contact a Valsartan Lawyer

If you were diagnosed with cancer or liver disease after taking Valsartan for hypertension, contact a qualified Valsartan Lawyer at 800-359-5690 or fill out a contact form. The Carlson Law Firm has a qualified legal team ready to take your call and answer all of your questions.

The Carlson Law Firm Can Help

The Carlson Law Firm is currently investigating claims related to valsartan cancer and liver damage. Our firm has a team of experienced dangerous drug attorneys ready to assist you with your potential lawsuit against the maker of your high blood pressure medication. If you or someone you know received a diagnosis for liver damage or cancer of the liver, kidney, stomach, or colon contact The Carlson Law Firm. We can help you decide if filing a valsartan recall lawsuit is the right step for you.

We have been protecting the rights of clients against big pharmaceutical companies for more than 40 years. The Carlson Law Firm is ready to answer all of your questions during a free case evaluation. Our legal team is ready to serve you with our signature customer service. We care. We can help.