In July of 2018, the U.S. Federal Drug Administration (FDA) began issuing safety warnings and recalls of certain versions of drug products containing the Active Pharmaceutical Ingredient (API) Valsartan. The recalled products contain an impurity, NDMA and/or NDEA, which pose an increased risk of cancer or other serious injury.
Recalled Valsartan lawsuits are being reviewed by the Law Offices of Kenneth W. DeJean for:
Valsartan and valsartan-containing drug products are medications commonly prescribed by doctors to treat heart failure and high blood pressure (hypertension).1 The FDA has recalled certain versions of Valsartan and Valsartan-containing medications due to the presence of an impurity, NDMA and/or NDEA.2
The U.S. Environmental Protection Agency (EPA) considers NDMA and NDEA probable human carcinogens - a chemical that can increase the risk of cancer in humans.3
According to the EPA, NDMA was formerly used in the production of rocket fuel and is currently only used for research purposes. The EPA has classified NDMA as a B2 (probable human) carcinogen based on the induction of tumors at multiple sites in different animal species exposed to NDMA by various routes.4 The U.S. Department of Health and Human Services states that NDMA is reasonably anticipated to be a human carcinogen. 5
The EPA has found that exposure to high levels of NDMA may cause liver, kidney and lung damage as well as cancers of these organs.
The presence of the potentially cancer-causing NDMA and/or NDEA is believed to be related to changes in the way the active substance was manufactured. Some levels of the impurity may have been in the valsartan-containing products for as long as four years.6
Click here to view a full list of recalled medications containing Valsartan (updated by FDA, as of November 27, 2018). The FDA has not recalled all medications containing Valsartan. A list of Valsartan-containing drugs that are not affected by the recall can be found here.
As of November 30, 2018, the FDA investigation of valsartan-containing medications is ongoing. For the latest information from the FDA, visit their website here.
The FDA has provided the following information for patients currently taking Valsartan medications that are under recall:
If you or a loved one has been diagnosed with cancer or developed kidney or liver damage after using recalled Valsartan, contact a dangerous drug attorney in Lafayette, Louisiana at The Law Offices of Kenneth W. DeJean today. Our experienced pharmaceutical drug lawyers can help you determine if you may have a Recalled Valsartan lawsuit.
The Law Offices of Kenneth W. DeJean
Phone: (337) 235-5294
Toll Free: (800) 284-3962