Valsartan Lawsuit

Valsartan is an active ingredient in many generic drugs, including drugs used to treat hypertension, heart failure, left ventricular heart failure, and left ventricular heart dysfunction following myocardial infarction.

Valsartan is also prescribed in conjunction with hydrochlorothiazide (HCTZ) to treat hypertension.

In May 2018, the European Medicines Agency announced its discovery that there existed a potentially dangerous impurity in valsartan medication sourced from Zhejiang Huahai Pharmaceuticals, a Chinese drug manufacturer.

In July 2018, the Food & Drug Administration (FDA) announced a recall for several types of generic valsartan, warning that the manufacturing process of these drugs resulted in impurities including a substance known as N-nitrosodimethylamine (NDMA), which is believed to increase the risk of cancer in animals and humans. NDMA is an organic chemical that is both toxic and carcinogenic, especially when mixed with water. The Environmental Protection Agency (EPA) indicates that the safe limit for human ingestion of NDMA is 96 nanograms.  FDA investigation of the contaminated valsartan lots demonstrates that the recalled pills exceeded safe levels.

Specific versions of Valsartan and Valsartan HCTZ may include the contaminated ingredients, thereby exposing patients to an increased risk of cancer and other serious side effects.

Many valsartan recalls been announced by the FDA to date, impacting batches sold by many pharmaceutical companies or re-packagers, including:

• 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

The Food and Drug Administration estimates that between 3 million and 3.7 million patients have been prescribed medications containing 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”. With this FDA action, the United States joins 22 other countries that have taken action involving valsartan.

The FDA’s press releases have unequivocally linked the presence of NDMA in valsartan to an error in the 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, the FDA is conducting a full-scale, comprehensive investigation into the safety of the recalled products.

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

If you took or are taking valsartan drugs that you believe are included in this recall, contact your doctor or healthcare provider immediately to discuss next steps. The FDA cautions patients against stopping the use of valsartan products “cold turkey” without first garnering advice from their doctor, as an abrupt stopping of the drug can cause severe adverse effects. Contact your doctor to discuss what course of action is best for you.