Valsartan Cancer Lawsuit

Many patients who have been prescribed valsartan and used the medication for weeks or months know that significant side effects are ranging from mild headaches to low blood pressure.

The U.S. Food and Drug Administration included a Black box warning with each prescription warning patients of associated fetal toxicity when taking the drug.

The most common effects experienced by patients tend to be brief and mild. They include:

• Nausea
• Coughing
• Headaches
• Diarrhea
• Fatigue
• Low blood pressure
• High blood potassium (hyperkalemia)
• Weight gain
• Possible hair loss
• Allergic reaction
• Reduced renal function (kidneys)
• Fetal toxicity
• Impotence
• Acute liver injury

 
Liver damage is a significant problem when taking valsartan, though reports are rare. During clinical trials, some participants who were given Diovan, the generic form of Valsartan, displayed elevated liver chemistries on occasion.

These individuals were dropped from the study and stopped taking the medication due precisely to their elevated liver chemistries to ensure their safety.

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 generic drugs by pharmaceutical companies became available, the China-based Zhejiang Huahai Pharmaceuticals Co. had manufactured most of the wholesale Valsartan sold to drug companies worldwide.

Zhejiang Huahai Pharmaceuticals company generated $50 million from the drug in 2017.

In 2018, Zhejiang notified regulators that NDMA residue had been discovered in many of its products, including batches of Valsartan.

What’s more, lots of Valsartan-contaminated tablets containing NDMA were found in products made by several other wholesale pharmaceutical manufacturers located in China and India.

In July 2018, the FDA announced 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 because it was contaminated with NDMA.

Only Valsartan sold exclusively by U.S. companies was affected, and the FDA asked those companies to take immediate action to protect patients.

Companies found to have contaminated Valsartan Solco Healthcare, Teva Pharmaceuticals, and Major Pharmaceuticals. Later, however, other companies would be added to the list.

Before the FDA pulled the dangerous products with severe side effects from the marketplace, twenty-two other countries had already recalled Valsartan products, including Canada, Taiwan, Hong Kong, and China.

The FDA discovered NDMA carcinogen in some of the recalled products: N-nitrosodiethylamine (NDMA), which is used by cancer researchers to induce liver tumors in laboratory animals.

The U.S. company Torrent Pharmaceuticals produced Valsartan drug products that were contaminated by toxic chemicals.

Torrent and several other pharma companies later issued a voluntary recall of some of their Losartan potassium products due to problems that occurred during the manufacturing processes.

The product was pulled due to “unacceptable” levels of NDMA as an active ingredient manufactured by Hetero Labs Ltd. Losartan is a generic drug similar to Valsartan, which is used to treat high blood pressure and heart failure.

In 2018, a published Danish paper revealed the risk of developing cancer after being exposed to NDMA found in contaminated batches of Valsartan medications.

A study had been done involving over 5100 Danish patients without any historical familiar or individual cases of cancer. The study lasted nearly 5.5 years.

The results of the study did not show an increased overall risk of developing cancer in the short-term when exposed to products containing NDMA-contaminated Valsartan.

However, there was uncertainty “about single cancer outcomes, and studies with longer follow-up are needed to assess long-term cancer risk.”

Valsartan Related Cancers of the Digestive System

More than any other organ, it seems NDMA wreaks the most havoc on the liver. It has been known to cause severe and non-cancerous liver conditions in humans and is used by cancer researchers to induce liver cancer tumors in rodents.

Liver Cancer generally has a poor prognosis because the liver is a vital organ essential to bodily function. Most cancers of the liver are the secondary cause, meaning that cancer originated in another organ or bodily system and spread or metastasized to the liver.

Alternatively, primary liver cancer originates in the organ and 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 sixty-seven.

A few benign and cancerous tumors can develop in the liver. Because of that, the symptoms of cancerous and non-cancerous 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.

• Fatigue
• Feeling bloated after eating
• Feeling full after eating small amounts of food
• Persistent heartburn
• Nausea or vomiting
• Stomach pain
• Weight loss

• Changes in bowel habits
• Unexplained weight loss
• Rectal bleeding or blood in stool
• Persistent abdominal discomfort

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

Since the recall, thousands of plaintiffs around the country have filed Valsartan lawsuits against the drug makers mentioned earlier (including China’s Zhejiang Huahai) and drug store retailers, including Walgreens and Wal-Mart.

The lawsuits allege negligence, strict liability, failure to warn,  fraud, and breach of express and implied warranty of merchantability, among other causes of action.

The class action litigation has been consolidated in New Jersey federal court in what is known as Multidistrict Litigation (MDL).

The Valsartan MDL (Valsartan MDL 2875) is currently pending before Judge Robert B. Kugler, U.S.D.J. and Judge Joel Schneider, U.S.M.J..

The defendants are being sued by plaintiffs who took the recalled Valsartan, who claim it put them at risk for cancer.

The plaintiffs’ claim in one argument that the drug companies should have been aware of safety problems involving Zhejiang that predate the recall.

The litigation is still in its early stages, and there have been no settlements or verdicts related to Valsartan cancer injuries announced yet. We will update this webpage as litigation progresses. Check back for ongoing Valsartan lawsuit updates.