Valsartan Recall

The Food and Drug Administration (FDA) has recalled Valsartan, a drug used to treat congestive heart failure and high blood pressure. Valsartan’s recall was necessary because the drug could pose a significant risk of cancer for patients. The recall represents one of the largest class 1 recalls in the history of the FDA. A class 1 recall means that there is a reasonable probability that the use of a drug will cause health problems or death. Approximately 2,000,000 Americans received letters informing them of the recall.

Risks from Valsartan

Valsartan is an angiotensin II receptor blocker (ARB) used to treat hypertension (high blood pressure), recent heart attacks, and heart failure.

Certain batches of valsartan produced by the Chinese company Zhejiang Huahai Pharmaceuticals and the India company Hetero Labs Limited have been contaminated with N-nitrosodimethylamine (NDMA). This chemical is a known carcinogen which was formerly used in production of liquid rocket fuel, antioxidants, additives for lubricants, and softeners for copolymers.

Short-term exposure to NDMA can cause liver damage (such as liver fibrosis and scarring). Long-term exposure can increase the risk of liver, kidney, and lung tumors.

According to the Environmental Protection Agency (EPA), NDMA is not currently produced in pure form or commercially used in the United States, except for research purposes.

The FDA's Statements Regarding Valsartan 

Beginning in Summer 2018, the FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards.

Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA), are probable human carcinogens (a substance that could cause cancer), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human carcinogen.


Nitrosamines are known environmental contaminants and found in water and foods, including meats, dairy products and vegetables.


The presence of these nitrosamine impurities in ARB medicines was unexpected. The FDA's ongoing effort has determined that these impurities may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents.

Complications

The drug Valsartan—prescribed for high blood pressure and heart failure—can come with serious known and acknowledged side effects, including the following:

  • High levels of potassium in the blood

  • Intense abdominal pain

  • Virus-caused infection

  • Joint pain

  • Kidney disease with a reduction in kidney function

  • Acute infection of the sinus, throat or nose

  • Nausea and vertigo

  • Appetite loss

  • Total lack of energy

  • Inflammation of the pancreas

  • Inflammation of blood vessels

  • Abnormal liver function

  • Decreased blood platelets and white blood cells

  • Chest pain

  • Hepatitis

  • Trouble breathing

Filing a Lawsuit

As a national firm experienced in representing clients injured by defective products, Weintraub Law is prepared to file appropriate lawsuits on behalf of patients who have suffered injuries due to the use of Valsartan.