Valsartan is an angiotensin II receptor blocker (ARB) medication which is used to treat hypertension, recent heart attack and heart failure. It was originally sold under the brand name Diovan, but is now mainly used as a generic medication.
Valsartan is also available as a generic medication in combination with other medications including hydrochlorothiazide and amlodipine, under the brand names Diovan HCT (with hydrochlorothiazide), Exforge (with amlodipine) and Exforge HCT (with both hydrochlorothiazide and amlodipine).
Recently, several generic manufacturers have come under fire by the Food and Drug Administration (FDA) and other regulatory agencies because valsartan products have been found to be contaminated with one or more cancer-causing agents.
Manufacturers may be facing thousands of class-action or medical injury lawsuits because their valsartan generic medications may be contaminated with:
- NDEA (N-Nitrosodiethylamine)
- NDMA (N-nitrosodimethylamine)
- NMBA(N-Methylnitrosobutyric acid)
The discovery of contaminants in valsartan drug products is an ongoing problem which continues to engulf more generic manufacturers and increasing number of potential contaminants. A number of manufacturers are already facing valsartan lawsuits but the number is expected to increase dramatically.
Contamination of Valsartan
Bulk valsartan used in manufacturing of brand and generic medications is only available from a few sources around the globe. Two of these bulk pharmaceutical chemical companies, Zhejiang Huahai Pharmaceuticals in China and Hetero Labs in India have been identified as the originator of contaminated valsartan batches which contained NDEA, NDMA or NMBA. All three chemicals are known industrial carcinogens which are strictly regulated or banned by the EPA.
Bulk valsartan purchased from either of these companies may have been used in hundreds of lots of valsartan containing medications, made by multiple manufacturers. These companies have been accused of producing and selling a contaminated product which may have injured thousands of people.
Manufacturers which may be included in valsartan class-action or medical injury lawsuits include:
- A-S Medication Solutions
- Bryant Rank Prepack
- Camber Pharmaceuticals
- HJ Harkins Company
- Major Pharmaceuticals
- Mylan Pharmaceuticals
- Northwind Pharmaceuticals
- NuCare Pharmaceuticals
- Preferred Pharmaceuticals
- Prinston Pharmaceutical
- RemedyRepack Inc.
- Solco Healthcare
- Teva Pharmaceuticals
- Torrent Pharmaceuticals Limited
Companies on the list with known contaminants have voluntarily or been forced to recall their products. Hundreds of lots of valsartan and combination products have already been recalled but the list continues to grow with the latest recalls being issued in March 2019.
As more manufacturers recall their valsartan medications, drug shortages have begun to occur. The FDA has responded by fast-tracking new generic approvals whose medications do not use ingredients from the named Chinese and Indian companies and have been proven to be free of NDEA, NDMA, and NMBA.
Pharmacy chains and large retail pharmacy businesses may also be facing valsartan class-action lawsuits such as:
- Throggs Neck Pharmacy
Patients who discover that their medication has been affected by a recall should not stop taking valsartan but should contact their health care provider to get a replacement prescription.
Valsartan Side Effects and Injuries
Normally, side effects of valsartan and ARB medications are mild to moderate such as dizziness and nausea and will go away over time. In some cases, the medication may have more severe effects such as reduced renal function, low blood pressure and high potassium levels but the most concerning side effects and injuries may have been caused by the contamination events.
NDEA, NDMA and NMBA have all been used to create cancerous tumors for research purposes in rats. All three are also known carcinogens which are used in industrial applications or are a cancer-causing byproduct which must be strictly controlled.
Acute or short-term exposure to these contaminants may cause liver damage, fibrosis or scarring or may damage other organ systems such as the kidneys. Chronic or longer-term exposure to any of the contaminants may result in liver failure, liver tumors and cancer or other types of cancer.
Symptoms of exposure to the contaminants may include:
- Abdominal cramps
Long-term or severe short-term exposure may cause symptoms of liver, kidney or lung failure and ultimately, may result in death.
Filing a Valsartan Lawsuit
People who were taking valsartan and experienced liver damage, liver tumors or other types of cancer may be eligible for compensation for their damages.
Damages may include:
- Past and future medical costs
- Lost wages
- Pain and suffering
- Punitive damages
Valsartan class-action and medical drug injury lawsuits are still in the filing stages and no settlements have been made. In addition, as more recalls and additional contaminants may be announced, many more lawsuits may be expected.
Though each case is unique, consultation with an attorney who is experienced in class-action and drug injury like valsartan can help to determine eligibility.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.