Valsartan Lawsuits

What is Valsartan?

Valsartan (Losartan, Irbesartan) is the generic version of Novartis AG’s branded medication Diovan and is used to treat both high blood pressure and congestive heart failure. Diovan was approved in 2002 and generated over $5 million in global profits. After Dovian’s patent expired, several manufacturers begin making and distributing valsartan, such as Zhejiang Huahai Pharmaceutical Company (ZHP) and its subsidiary. Patient and physician concerns have been documented over the discovery of the substances NDMA or nitrosodimethylamine, and NDEA or nitrosodiethylamine. The International Agency for Research on Cancer classifies NDMA as ‘probably carcinogenic to humans’ and believes that NDMA ‘should be regarded for practical purposes as if it were carcinogenic to humans.’

Valsartan products have been the subject of voluntary recalls after testing found NDMA in tablets made by Zhejiang Huahai at its plant in China. The FDA has not confirmed all Valsartan products are affected and regulators believe the contamination, which may have existed in some products in 2012, is a result of changes in the way the ingredients are manufactured. Claims are that these generic versions were made using poor manufacturing processes that cut corners and caused the drugs to be tainted with impurities. Patients who ingested the drugs from FDA-recalled lots have reported liver damage, liver cancer, colorectal cancer, kidney cancer, kidney damage and gastric cancer.  The FDA has banned further imports of drugs made by ZHP.

What is NDMA?

  • NDMA is a semi volatile organic chemical that forms in both industrial and natural processes. It is a member of N-ni-trosamines, a family of potent carcinogens
  • NDMA is not currently produced in pure form or commercially used in the United States, except for research purposes. It was formerly used in production of liquid rocket fuel, antioxidants, additives for lubricants and softeners for copolymers
  • NDMA is also an unintended byproduct of the chlorination of wastewater and drinking water at treatment plants that use chloramines for disinfection

How does Valsartan work?

Valsartan is a member of a class of medications called angiotensin receptor blockers (ARBs). The drug works by blocking the action of certain natural substances that tighten the blood vessels, and allowing the blood to flow smoothly, while ensuring the heart pumps more efficiently. While chronic high blood pressure is common, when not treated it can cause damage to the brain, heart, blood vessels, and kidneys. The resulting damage to these organs may cause heart attack, heart failure, stroke, loss of kidney function, and other serious problems. Valsartan is also prescribed to treat diabetic nephropathy (kidney disease in people with diabetes and high blood pressure).

What are some of the dangerous side effects and medical complications of Valsartan?

Contact your healthcare provider immediately if you have any of the following dangerous side effects while taking Valsartan:

  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles or lower legs
  • hoarseness
  • difficulty breathing or swallowing
  • unexplained weight gain

Valsartan can also cause blurry vision, coughing, excessive tiredness, diarrhea, headache, stomach pain, and rashes.  If you experience consistent side effects, or any of those more dangerous, you or your doctor can send a report to the FDA MedWatch Adverse Event Reporting program online or toll-free by phone at 1-800 332-1088.

Does Valsartan cause liver damage?

Valsartan can cause liver damage. Sometimes the damage can be severe.  Valsartan can harm the liver because the drug can be difficult for the liver to metabolize.  The liver is an organ in the upper right abdomen. It performs important functions related to metabolism, such as:

  • helping digestion by creating bile
  • filtering toxins
  • breaking down carbohydrates, fats and proteins
  • storing vitamins and minerals
  • creating blood proteins
  • helping the body form blood clots

According to the National Institutes of Health (NIH), some people taking Valsartan suffered acute liver injury. In these cases, the damage usually happened within 1 to 8 weeks of starting Valsartan. Symptoms of this type of injury caused by Valsartan are like hepatitis symptoms, which include:

  • fatigue
  • flu-like symptoms
  • dark urine
  • pale stool
  • abdominal pain
  • loss of appetite
  • unexplained weight loss
  • yellow skin and eyes, which may be signs of jaundice

The NIH also notes that Valsartan-induced acute liver injury can develop into an even more serious liver disease called cholestasis. This disease occurs when the flow of bile from the liver is reduced or blocked. Bile is fluid produced by the liver that aids in the digestion of food, especially fats.  Symptoms of cholestasis are:

  • jaundice, which is a yellowing of the skin and the white of the eyes
  • dark urine
  • light-colored stool
  • abdominal pain
  • fatigue
  • nausea
  • excessive itching

The liver plays an important role in metabolizing medicine. Some medicines are more difficult for the liver to metabolize and may be toxic to the liver. If a patient already has liver problems, and the patient’s liver can’t break down Valsartan, the drug could build up in the body and cause damage.

The Dunken Law Approach to Representing Patients with Valsartan Use

You might have a legal claim if you were prescribed recalled Valsartan, Losartan or Irbesartan with a diagnosis of colon or gastric cancer, or evidence of kidney/liver damage or disease with a minimum 3-day hospitalization.  Potential claimants should be between the ages of 40 to 60 and must have been diagnosed with a qualifying cancer after regular use of the recalled drug for at least 30 days between 2014 to present. The Dunken Law Approach is hyper client-focused: with our high-touch client concierge platform you’ll receive regular litigation updates, customized content to explain the mass tort process and proactive communication. Speak to one of our knowledgeable case management specialists and receive a free legal consultation. Use the form on this page to get started.