Schroth & Schroth LLC
Valsartan May Lead to an Increased Risk of Cancer
People who took the generic blood pressure drug valsartan may face an increased risk of certain cancers due to possible exposure to the carcinogenic chemical N-nitrosodimethylamine (NDMA), the same chemical that led to the high-profile removal of all Zantac and ranitidine products from the market in 2020. The companies that made and distributed valsartan pills contaminated with toxic NDMA are now facing a growing number of product liability lawsuits filed by former valsartan users who were diagnosed with cancer, which seek to hold the drug makers responsible for their tainted drug products. Lawsuits pursuing compensation for personal injuries and other losses allegedly caused by generic valsartan, losartan, and irbesartan products have been consolidated in a New Jersey federal court as part of a multidistrict litigation.
Generic Valsartan Tainted by NDMA
Valsartan is the name of a generic blood pressure medication widely used to treat high blood pressure and congestive heart failure. Valsartan belongs to a class of drugs known as angiotensin II receptor blockers (ARBs), which work by blocking the peptide hormone angiotensin II, which causes the constriction of blood vessels leading to high blood pressure. Many people taking valsartan have found it to be effective in lowering their blood pressure and reducing their risk of heart failure. However, it was discovered in 2018 that batches of generic valsartan manufactured at a Chinese facility were contaminated with the cancer-causing substance N-nitrosodimethylamine (NDMA) and that the toxic chemical may have been present in the drugs for as many as four years before it was detected.
Many generic drugs that contain valsartan as the active ingredient have since been recalled due to the unexpected and potentially dangerous presence of NDMA and other nitrosamine impurities, which can increase the risk of cancer in users. Among the types of cancer that have been linked to tainted valsartan medications are:
- Liver cancer
- Kidney cancer
- Stomach cancer
- Colorectal cancer
- Bladder cancer
- Pancreatic cancer
- Prostate cancer
NDMA Contamination Leads to Valsartan Drug Recalls
The discovery that certain batches of generic valsartan were contaminated with NDMA led to a wave of recalls beginning in July 2018, when the FDA announced that some generic valsartan manufacturers were initiating recalls after discovering the presence of NDMA in their drug products. The recalls affected several drugs containing valsartan, as well as other drugs containing the generic blood pressure drugs losartan and irbesartan. The NDMA contamination was traced back to Zhejiang Huahai Pharmaceuticals (ZHP) and Zhejiang Tianyu in China and Hetero Labs Limited in India, which together supply more than half of the valsartan drug products distributed in the United States. According to the FDA, the NDMA found in the valsartan medications is believed to have been a chemical byproduct produced as a result of changes made to the manufacturing process.
In the months that followed the initial valsartan recalls, the FDA announced that it had identified another cancer-causing chemical in the contaminated batches of valsartan. “[A]n additional nitrosamine, N-nitrosodiethylamine (NDEA), has also been detected in some valsartan products,” the FDA announced in an April 2019 report. In an update on nitrosamine impurities published on its website, the World Health Organization (WHO) reported that “NDMA and NDEA belong to the so-called ‘cohort of concern’, which is a group of highly potent mutagenic carcinogens that have been classified by the WHO’s International Agency for Research on Cancer as probably human carcinogens.”
According to a Questions and Answers page on the FDA website, the potentially dangerous nitrosamine impurities found in generic ARB medications and combination medications containing valsartan, losartan and irbesartan include NDMA and NDEA, which are probable human carcinogens, as well as N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), which is a potential human carcinogen. These potentially dangerous organic compounds can be formed unintentionally through industrial processes, or they can occur naturally in certain foods and drinks, such as cured meats, certain cheeses, fish, and beer. The WHO warns that “Although [nitrosamines] are also present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable.”
Valsartan Users Seeking Compensation for Cancer Diagnoses
Consumers rely on drug manufacturers to develop and sell medications that are safe and work the way they are meant to work. Unfortunately, when drugs are not properly scrutinized or tested before being made available to consumers, the consequences can be devastating for users and their loved ones. According to estimates, three million Americans take valsartan-containing medications every year and more than one million people may have been exposed to NDMA-contaminated valsartan before the drugs were recalled. If you or someone in your family was diagnosed with stomach, liver, kidney, colorectal, bladder, or pancreatic cancer or another type of cancer after taking the blood pressure drug valsartan, you may be eligible to file a valsartan injury lawsuit against the drug manufacturer.