Valsartan Lawsuit Update
FDA Finds Another Impurity in Recalled Blood Pressure and Heart Drug.
The FDA has been testing batches of the recalled drug as well as batches that have not been recalled. Several additional batches have been found to contain an additional impurity, N-Nitrosodiethylamine, or NDEA, which is also a known carcinogen.
Why is Valsartan Prescribed?
Valsartan is prescribed to treat high blood pressure and heart failure, and to improve survival after a cardiac arrest. This blood pressure medication is from a class of drugs called the angiotensin II receptor blockers (ARBs). Its primary function is to block the action of natural substances that constrict blood vessels. This relaxes the blood vessels which allows blood to travel more smoothly through the body, and the heart to pump more efficiently. The medication is commonly available in 40 mg, 80 mg, 160 mg or 320 mg tablets.
In July of 2014, an authorized generic version of Diovan® (valsartan) was introduced in the United States for the treatment of high blood pressure (HBP).
Risk of Cancer Forces Recall of Blood Pressure and Heart Drug, Valsartan.
In July of 2018, the FDA announced a voluntary recall of several medicines containing Valsartan after the detection of an impurity in the drug. The detected impurity, N-nitrosodimethylamine (NDMA), is a known carcinogen. NDMA is a semi-volatile organic chemical produced as a by-product of several industrial processes.
Known to be a carcinogen, it is used to create cancer in rats for cancer research. The United States FDA recall came after 22 other countries issued recalls of over 2,300 Valsartan batches. In August 2018, the FDA announced further medications containing Valsartan were subject to the recall because of the presence of NDMA. Additional batches have been found to contain another impurity, N-Nitrosodiethylamine, or NDEA, which is also a known carcinogen.
The FDA has stated:
“The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.”
Valsartan Related Injuries
Exposure to NDMA/NDEA can cause cancer. Injuries from NDMA/NDEA exposure include but are not limited to:
- Stomach Cancer
- Intestinal Cancer
- Colorectal Cancer
- Esophageal Cancer
- Liver Cancer
- Prostate Cancer
- Blood Cancer/Leukemia
- Multiple Myeloma Cancer
- Non-Hodgkins Lymphoma
- Pancreatic Cancer
Multiple drug manufacturers have voluntarily recalled heart and blood pressure medications containing Valsartan following the discovery that the drug can be contaminated with N-nitrosodimethylamine (NDMA).
The NDMA contamination has been linked to valsartan produced by Zhejiang Huahai Pharmaceuticals of China and Hetero Labs Limited of India. Due to the finding of NDMA in valsartan, the following companies have recalled their non-expired products.
- Teva Pharmaceuticals USA labeled as Major Pharmaceuticals
- Prinston Pharmaceuticals Inc. Labeled as Solco Healthcare LLC
- Teva Pharmaceuticals labeled as Actavis LLC
- Remedy Repack
- A-S Medication Solutions LLC
- Bryant Ranch Prepack Inc.
- H J Harkins Company Inc. dba Pharma Pac
- Hetero Labs, Inc. labeled as Camber Pharmaceuticals, Inc.
- NuCare Pharmaceuticals, Inc.
- Northwind Pharmaceuticals
- Preferred Pharmaceuticals, Inc.
- Torrent Pharmaceuticals Limited
- and more…