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The discovery of several carcinogenic impurities in high blood pressure medications has sparked one of the largest prescription drug recalls in years. Valsartan is one of the most widely prescribed medications to treat high blood pressure. In addition to hypertension, both drugs treat patients with heart failure and those who have experienced a heart attack. Despite their widespread use, a valsartan recall went into effect in July 2018 because of traceable amounts of the carcinogen (N-Nitrosodimethylamine) NDMA. The Carlson Law Firm is currently investigating several claims that valsartan led to cancer. If you have received a tumor, cancer or liver damage diagnosis after taking valsartan, contact us. We can help you file a valsartan recall lawsuit.
For more than 40 years, The Carlson Law Firm has represented thousands of people against the negligence of big pharmaceutical companies. In many cases, businesses put profits over the health and safety of the people their medications are supposed to help. This is never OK. Civil lawsuits against companies that don’t prioritize your safety are a deterrent for wrongdoing and serve as a way to ensure that companies are held accountable. These lawsuits also ensure that you are getting the justice you deserve for any damages the drug caused you.
If you received a cancer or liver damage diagnosis after taking Valsartan, contact us to schedule a free, no-obligation consultation.
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. 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.
The Valsartan Recall
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 and impurity that poses a potential cancer risk. Upon facility inspection and testing, the FDA found that a change in the manufacture of Valsartan led to the formation of N-Nitrodoimethylamine (NDMA). The company’s issued the recalls at the FDA’s request. Experts believe a change in the manufacturing process is the reason for NDMA’s presence.
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 is Irbesartan?
Irbesartan went under voluntary recall in October 2018, after trace amounts of NDEA were found. The recall expanded in 2019 to cover additional lots of irbesartan blood pressure medication. Zhejiang Huahai Pharmaceuticals in China made Irbesartan products. ZHP is also the manufacturer at the center of valsartan products.
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.
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 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 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 Inc.
- TevaPharmaceuticals USA labeled as Actavis
- Torrent Pharmaceuticals Limited
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:
- ACE inhibitors
- Calcium channel blockers
- Alpha-2 receptor agonists
- Combined alpha and beta-blockers
- Central agonists
- Peripheral adrenergic inhibitors
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.
Zhejiang Huahai Pharmaceuticals Import Alert
In September 2018, the FDA placed products made by Zhejiang Huahai Pharmaceuticals on import alert. By doing so, the FDA said it was protecting patients while the manufacturer determined how the impurities were introduced. Additionally, ZHP needs to determine how to address the quality and safety of its products. The import alert stopped all drug high blood pressure medications made by ZHP from entering the U.S.
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.
What is a Mass Tort?
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.