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Valsartan (which also goes by the brand name Diovan) is a popular generic medication prescribed by doctors to treat congestive heart failure and hypertension. The drug is classified as an ARB (angiotensin II receptor blocker) and is used to increase a patient’s longevity after suffering a heart attack because it is known to relax blood vessels and improve blood flow. It also helps lower blood pressure, prevent stroke, and prevent kidney malfunction in diabetes patients. Millions of Americans have taken Valsartan for these conditions.
In July 2018, the U.S. Food and Drug Administration (FDA) recalled some Valsartan products after it was discovered they had been contaminated by a chemical linked to cancer. The federal agency said that traces of the carcinogenic compound N-nitrosodimethylamine (NDMA), which was formerly used in rocket fuel among other things, were discovered in the drugs that had been recalled. This recall is the subject of a “mass tort” litigation currently working its way through in federal court.
Exposure to NDMA can seriously damage the liver and is believed to increase the risk of developing cancer of the liver, gastrointestinal tract, stomach, kidneys, and colon even in relatively small amounts. The organic chemical is known to cause cancer in research animals and is considered by the medical community to be a “probable” human cancer-causing agent.
If you or a loved one has taken Valsartan, you are probably understandably alarmed and confused. In this article we will try to address some of your concerns:
- What is NDMA?
- How did Valsartan become contaminated with a suspected carcinogen?
- What types of cancer is NDMA linked to and what are their symptoms and prognosis?
- How do I know if my Valsartan prescription was affected by the recall?
- What is the status of Valsartan litigation?
Contact Our Attorneys to Discuss Your Potential Claims Against the Manufacturers of Valsartan
If you were exposed to Valsartan between 2015 and 2019, you should speak to your doctor right away. If you have taken the drug and developed one of the cancers listed, you should consider taking immediate legal action against the drug makers who manufactured, marketed, and sold the defective drug. Time is of the essence, because there are statutes of limitations that apply to filing personal injury claims at both the federal and state levels.
The drug recall attorneys at Rosenfeld Injury Lawyers LLC are monitoring potential Valsartan lawsuits across the United States. Our office is centrally located in Chicago, Illinois, and we are here to provide you with the latest information on recalls and pending litigation involving monetary damages. We invite you to discuss your experience and your legal options with us at no cost or obligation.
If you meet the following criteria, our Valsartan recall attorneys would like to review your case with you:
- You used Valsartan between 2015 and the present
- You have been diagnosed with cancer of the liver, colon, or stomach, OR you experienced liver damage which required hospitalization
- You used Valsartan for at least one year prior to your cancer diagnosis
If you or a loved one meets all of the above criteria, we urge you to contact our office today for a free case consultation.
What is NDMA?
NDMA is an organic compound that is described as a waste product of industrial processes including the making of lubricants and pesticides. It is part of the N-nitrosamine family of potent carcinogens. The yellowish liquid is said to be present at supposedly safe micro levels in some food products—particularly cured meats—and water supplies, even beer. The toxic chemical has been found to damage the liver and other organs in humans and cause cancer in laboratory rats. The U.S. Environmental Protection Agency (EPA) has concluded that NDMA is a “probable human carcinogen” that can increase a person’s risk of developing cancer.
Although most of what is currently known about NDMA’s carcinogenic qualities comes from animal-based studies, the World Health Organization has reported that several case–control studies and one cohort study of dietary intake of NDMA by humans showed results “supportive of the assumption that NDMA consumption is positively associated with either gastric or colorectal cancer.”
How did Valsartan Become Contaminated With a Suspected Carcinogen?
According to the FDA, the presence of NDMA in Valsartan was “unexpected” and related to “changes in the way the active substance was manufactured.” Since about 2012 when the drug went generic, the China-based Zhejiang Huahai Pharmaceutical Co. had manufactured most of the wholesale Valsartan sold to drug companies worldwide, generating $50 million from the drug in 2017. In 2018, Zhejaing notified regulators that NDMA residue had been discovered in many of its products including Valsartan.
What’s more, Valsartan contaminated with NDMA was also found in products made by several other wholesale pharmaceutical manufacturers located in China and India.
In July 2018, the FDA issued a safety warning to alert patients, healthcare professionals, and the public of a voluntary recall of Valsartan because of the chemical’s probable carcinogenic effects. Only Valsartan sold by certain U.S. companies was affected, and FDA asked those companies to take immediate action to protect patients. They were Solco Healthcare, Teva Pharmaceuticals, and Major Pharmaceuticals, but later other companies would be added to the list.
(Before the FDA pulled the dangerous products from the marketplace, 22 other countries had already recalled Valsartan products, including Canada, Taiwan, Hong Kong and China.)
FDA discovered NDMA as well as a second carcinogen in some of the recalled products: N-nitrosodiethylamine (NDEA), which is used by cancer researchers to induce liver tumors in laboratory animals. The U.S. company Torrent Pharmaceuticals produced Valsartan contaminated by both chemicals. Torrent and several other pharma companies later issued a voluntary recall of some of their Losartan potassium products due to “unacceptable” levels of NDEA in an active ingredient manufactured by Hetero Labs Ltd. Losartan is a generic drug similar to Valsartan which is used to treat high blood pressure.
What Types of Cancer is NDMA Linked to and What are Their Symptoms and Prognosis?
Cancers of the Digestive SystemMore than any other organ, it seems NDMA wreaks the most havoc on the liver. It has been known to cause serious, non-cancerous liver conditions in humans and is used by cancer researchers to induce liver tumors in rodents.
Causes and Symptoms of Liver CancerBecause the liver is a vital organ essential to bodily function, liver cancer generally has a poor prognosis. Most cancer of the liver is secondary, meaning that the cancer originated in another organ or bodily system and spread or metastasized to the liver. Primary liver cancer which originates in the organ itself accounts for only two percent of cancers in the U.S. Its causes include hepatitis, alcohol abuse, smoking and possibly obesity. Primary liver cancer strikes twice as many men as women, at an average age of 67.
A number of benign tumors can develop in the liver as well as cancerous ones, so the symptoms could be similar. Symptoms of liver cancer include:
- Unexplained weight loss
- Loss of appetite
- Upper abdominal pain
- Nausea and vomiting
- Fatigue
- Jaundice of the skin or eyes
- White, chalky stools
Liver cancer is generally treated through surgical removal of tumors and chemotherapy.
Symptoms and Treatment of Stomach CancerCancer of the stomach (adenocarcinoma) is generally more treatable than liver cancer, especially when caught at an early stage. One of its precursors can be the condition known as GERD, or acid reflux. It is also believed to be associated with obesity and smoking, as well as poor diet.
Some symptoms of stomach cancer can be similar to liver cancer, and include:
- Fatigue
- Feeling bloated after eating
- Feeling full after eating small amounts of food
- Persistent heartburn
- Nausea or vomiting
- Stomach pain
- Weight loss
Treatments for stomach cancer depend on the stage that the disease has progressed to, and include surgery (including removal of the stomach), radiation and chemotherapy.
Symptoms and Treatment of Colorectal CancerCancer of the colon (large intestine) is among the most common types of cancer in the U.S. If caught early, it is treatable and even curable. It is most common among older adults but can strike at any age. Most colorectal cancer starts as polyps, or growths, on the inner lining of the colon or rectum. If precancerous polyps are not removed, they can turn into cancer. Risk factors for colorectal cancer include a diet high in fat or red meat, family history, and being over age 50, People over 50 are advised to have screening colonoscopies every five years and removal of any polyps found.
Symptoms include:
- Changes in bowel habits
- Unexplained weight loss
- Rectal bleeding or blood in stool
- Persistent abdominal discomfort
Treatment for colorectal cancer is fairly similar to stomach cancer and includes removal of cancerous tumors and if necessary parts of the colon (colostomy) or rectum, and chemotherapy.
How do I Know if my Valsartan Prescription was Affected by the Recall?
The FDA recommends that patients contact their health care providers to determine if the medication they are currently taking has been recalled, but not to discontinue taking it until their doctor has prescribed a replacement, because the drug may be treating a serious medical condition that could worsen if stopped.
The agency has released a list of recalled drugs (see below) containing NDMA. To determine if your own medication was recalled, find the manufacturer name on your prescription bottle. If you can’t locate it, contact your pharmacist, who can assist you in identifying the drug maker.
If your medication has been recalled, contact your doctor and discuss alternative treatment options. He or she may be able to prescribe another drug or a brand of Valsartan that is not part of the recall.
July 2018 Valsartan Voluntarily Recall| Drug Company | Recalled Medicine |
|---|---|
| Major Pharmaceuticals | Valsartan 80 mg and 160 mg tablets |
| Solco Healthcare LLC | Valsartan 40 mg, 80 mg, 160 mg, 320 mg |
| Actavis – Teva Pharmaceuticals USA | Valsartan 40 mg, 80 mg, 160 mg, 320 mg |
| A-S Medication Solutions LLC | Valsartan 80 mg, 160 mg |
| Bryant Ranch Prepack Inc. | Valsartan 80 mg, 320 mg |
| H J Harkins Co. | Valsartan 160 mg |
| Northwind Pharmaceuticals | Valsartan 80 mg, 160 mg, 320 mg |
| Quality Care Products LLC (Lake Erie Medical) | Valsartan all doses |
| NuCare Pharmaceuticals | Valsartan all doses |
| Proficient Rx | Valsartan all doses |
| Actavis – Teva Pharmaceuticals USA | Valsartan w/ hydrochlorothiazide (HCTZ) 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, 320 mg/25 mg |
| AvKARE | Valsartan w/ hydrochlorothiazide (HCTZ) 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, 320 mg/25 mg |
| A-S Medication Solutions LLC | Valsartan 80 mg, 160 mg & Valsartan w/ hydrochlorothiazide (HCTZ) 160 mg/12.5 mg, 320 mg/25 mg |
What is the Status of Valsartan Litigation?
Since the recall, lawsuits over Valsartan have been brought by thousands of plaintiffs around the country against the above named drugmakers (including China’s Zhejiang Huahai) and drug retailers including Walgreens and Wal-Mart. The lawsuits allege negligence, strict liability, fraud and breach of express and implied warranty of merchantability, among other causes of action. The litigation has been consolidated in New Jersey federal court in what is known as a Multidistrict Litigation (MDL).
The defendants are being sued by plaintiffs who took the recalled Valsartan who claim it put them at risk for cancer, and among their arguments is that the drug companies should have been aware of safety problems involving Zhejaing that predate the recall.
The litigation is still in its early stages and there have been no settlements or verdicts related to Valsartan injuries announced yet.
We will update this webpage as litigation progresses. Check back for ongoing Valsartan lawsuit updates.
Contact an Attorney if You Have Developed Cancer After Taking Valsartan
If you or a loved one has been prescribed a recalled Valsartan medication made by Solco Healthcare, Major Pharmaceuticals or Teva Pharmaceuticals and developed health problems associated with the liver, kidneys, colon, or stomach, contact the defective drug injury attorneys at Rosenfeld Injury Lawyers today at (888) 424-5757. Schedule a no obligation, free consultation to discuss whether you have a valid claim for compensation. The medication you are taking now could cause serious medical complications in the months or years ahead.
Our law firm accepts Valsartan stomach, liver, kidney and color-rectal cancer cases on a contingency fee arrangement where a legal fee is charged only after we have successfully resolved your case. If we are unable to secure compensation on your behalf, you owe us nothing. Let us get to work for you now.
The material on this page was prepared by attorney Jonathan Rosenfeld. Updated October 2019.
Similar to Valsartan, Rosenfeld Injury Lawyers LLC is currently reviewing Zantac cancer lawsuits.
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