Valsartan: Too Many Recalls to Count

What is Valsartan?

Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs) and is used to treat high blood pressure and heart failure. Doctors commonly prescribe valsartan to people who have suffered from a heart attack or have type II diabetes. Valsartan is the generic version of the drug Diovan which is an angiotensin II receptor blocker (ARB), meaning it widens blood vessels to reduce blood pressure and increase blood flow.

Valsartan Contamination

In July 2018, the FDA announced a voluntary recall of several drugs containing valsartan due to contamination with a cancer-causing impurity known as N-nitrosodimethylamine, or NDMA. Other drugs affected by the valsartan recall include losartan and irbesartan. The FDA estimates that millions of Americans take valsartan to treat high blood pressure and heart failure. The initial recall in 2018 involved more than half of the US supply of valsartan causing market shortages of the drug. The agency estimates the tainted drug first entered the US market around 2014. Valsartan is an ingredient which is frequently combined with other medicines into a single pill.

After a thorough investigation, the FDA traced the contaminated drugs to Chinese manufacturers Zhejiang Huahais and Zhejiang Tianyu as well as Hetero Labs Limited located in India. In September 2018, the FDA announced it had found another toxic chemical in tainted valsartan batches called N-nitrosodiethylamine (NDEA). Like NDMA, the chemical has been linked to cancer. Recalls of the tainted lots of valsartan rolled out over several months and affected hundreds of batches of valsartan. It is estimated that 1.5 million people may have taken contaminated valsartan in 2018.

In an ongoing investigation, the FDA is working to determine what caused the impurities and contamination and what changes need to be made in the manufacturing process to prevent further issues.

In 2016 almost 60 million prescriptions were written for losartan drugs and 14 million for valsartan or a drug that includes valsartan as an ingredient. An additional 3.6 million prescriptions were written for irbesartan in 2016. Because valsartan is so widely used, the list of recalled products continues to evolve. Its best to refer to the FDAs website for the most current list of recalled products.

Injuries Linked to Contaminated Valsartan

Some serious side effects have been linked to valsartan including the following:

  • Cancer of the gastrointestinal tract
  • Cancer of the digestive organs
    • Stomach
    • Colon
    • Rectum
    • Liver
    • Pancreas
    • Esophageal
    • Prostate

Mass Action Litigation for Valsartan

In February 2019, the Judicial Panel on Multidistrict Litigation (JPML) created MDL 2875 consolidating valsartan lawsuits in the USDC District of New Jersey. Because it is so widely used, there is the potential for thousands of valsartan lawsuits to be filed before any of the cases go to trial. Bloomberg reported in April 2019, that attorneys handling valsartan claims expect more than 2,000 personal injury lawsuits to be filed within the next two years.


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