Valsartan Lawsuit

The European Medicines Agency announced in May 2018 that there is a potentially dangerous impurity in valsartan medication sourced from Zhejiang Huahai Pharmaceuticals, a China-based drug manufacturer.

In July 2018, the Food & Drug Administration (FDA) announced a recall for several varieties of generic valsartan, warning consumers of impurities in the manufacturing process that resulted in the inclusion of a substance known as N-nitrosodimethylamine (NDMA), which is known to increase the risk of cancer. NDMA, an organic chemical, is both toxic and carcinogenic when mixed with water. The Environmental Protection Agency (EPA) states that the maximum safe limit for human ingestion of NDMA is 96 nanograms. In its investigation, the FDA noted that the contaminated valsartan lots contained unsafe levels of NDMA.

Specific iterations of valsartan and valsartan HCTZ may be contaminated with NDMA, thereby exposing users to an increased risk of cancer and other serious side effects impacting the liver and kidneys.

Many valsartan recalls been announced by the FDA to date, including products sold by many pharmaceutical companies or re-packagers. The list includes:

• Major Pharmaceuticals
• Actavis
• Teva Pharmaceuticals
• Solco Healthcare
• A-S Medication Solutions LLC
• AvKARE
• RemedyRepack
• Bryant Ranch Prepack Inc.
• H.J. Harkins Company, Inc.
• Lake Erie Medical, Doing Business As Quality Care Products LLC
• NuCare Pharmaceuticals
• Proficient Rx

According to the FDA, an estimated 3 million to 3.7 million patients have been prescribed medications that contain valsartan each year for a three-year period ending in 2018. According to Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, the FDA has “carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients”. The FDA is among 22 other governmental agencies worldwide that have taken action regarding valsartan.

The FDA’s statements and studies have suggested a strong link between the presence of NDMA in valsartan and an error in the drug’s manufacturing process, stating that “the presence of NDMA [in valsartan] was unexpected and is thought to be related to changes in the way the active substance was manufactured.” As a result of this concerning issue with the manufacturing of valsartan, the FDA is conducting an in-depth investigation into the safety of the recalled lots.

The FDA’s online adverse events reporting system reveals that there have been more than 19,000 severe reports, including over 2,800 deaths, connected to valsartan-induced injury dating back to 2009.

If you have taken valsartan-based drugs that are included in the FDA recall, contact your doctor or healthcare provider immediately to discuss the appropriate next steps. According to the FDA, patients should not cease use of valsartan drugs cold turkey without first getting the advice of their doctor, as a gradual step-down from the drug may be more beneficial to the patient. Contact your doctor to discuss what course of action is best for you.

If you or a loved one took recalled valsartan and subsequently developed complications such as liver cancer, kidney cancer, or tumors, please call our attorneys to discuss your next steps and possible legal recourse against valsartan manufacturers.