Patients who have developed cancer after taking valsartan may be eligible to pursue a claim and seek financial compensation.
Valsartan is a medication used for the treatment of high blood pressure, congestive heart failure, and to improve survival after a heart attack. Valsartan belongs to a group of anti-hypertension drugs called angiotensin II receptor antagonists. The FDA has issued recalls for valsartan due to traces of carcinogens called N-nitrosodimethylamine (NDMA) and N‑nitrosodiethylamine (NDEA) found in some batches of the drug. Lawsuits are being filed against manufacturers by patients and surviving family members of those who took valsartan and developed liver, kidney, gastric, and colorectal cancer.
If you or a loved one was treated with valsartan and was later diagnosed with cancer, contact Maxwell Law Group LLP today. We can answer your questions and review your case for free.
What is Valsartan?
Valsartan is a medication used to lower high blood pressure, treat and manage congestive heart failure, and improve survivability after a heart attack. It belongs to a group of antihypertensive drugs called angiotensin II receptor blockers (ARBs).
The FDA approved the Novartis’ branded and patented version of Valsartan, Diovan, in 2002. Novartis’ patent expired in 2012, and many generic drug manufacturers have since produced and sold the drug.
Brand names for drugs containing Valsartan include Diovan, Prexxartan, Amlodipine, Exforge,
Valsartan Quick Facts
Medication for high blood pressure and congestive heart failure management
Liver, kidney, gastric, and colorectal cancer
Novartis (patent expired in 2012)
How Does Valsartan Work?
Valsartan works by inhibiting the binding of angiotensin II to angiotensin receptors. This effectively stops angiotensin activity and relaxes blood vessels to decrease vascular resistance and blood pressure. It also inhibits aldosterone secretion, which inhibits sodium and water reabsorption in the kidneys.
Risks and Warnings
Valsartan-based drugs come with a warning that the drug may cause lower than normal blood pressure. It can also increase potassium levels in the bloodstream.
Valsartan includes a black box warning regarding use during pregnancy. The drug can cause fetal toxicity, which can ultimately lead to neonatal injuries and death. If pregnancy is suspected, it is advised that valsartan be discontinued as soon as possible.
In August 2018, the FDA posted an announcement regarding the recall of all valsartan tablets from manufacturer Torrent Pharmaceuticals. This is due to an unexpected impurity found in an active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected was N-
Another recall was announced in August 2018 for all valsartan products distributed by Camber Pharmaceuticals.
Additional Impurities and Recent Analysis
An update was released in September 2018 stating that additional unexpected impurities had been found in Torrent Pharmaceuticals’ valsartan products. N-Nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen, was found in three lots of the drug.
In October 2018, the FDA released the laboratory analysis of generic valsartan products from different pharmaceutical companies. It is estimated that 1 out of 8,000 patients who took the highest valsartan dose containing NDMA could develop cancer.
In November 2018, Teva Pharmaceuticals announced a nationwide recall of many of its valsartan product due to NDEA impurities. In December 2018, Mylan Pharmaceuticals also announced a recall of all of its valsartan-containing products.
For a current list of valsartan-containing products under recall, please click here. As of December 2018, the recall includes valsartan-containing products from the following companies:
- A-S Medication Solutions LLC
- Bryant Ranch Prepack Inc.
- Camber Pharmaceuticals
- HJ Harkins Company Inc. (Pharma Pac)
- Northwind Pharmaceuticals
- NuCare Pharmaceuticals
- Preferred Pharmaceuticals
- Prinston Pharmaceutical Inc., including its subsidiary Solco Healthcare LLC
- Proficient Rx LP
- RemedyRepack Inc.
- Teva Pharmaceuticals, including its subsidiaries Major Pharmaceuticals and Actavis
- Torrent Pharmaceuticals Limited
Injuries from Valsartan
NDMA is a volatile, combustible chemical compound that is primarily used in laboratories to induce tumors in animals for research. Eye and skin irritation and liver damage can be experienced due to NDMA exposure. It is usually a food and water
Meanwhile, NDEA is a water-soluble, volatile oil also used to induce liver tumors in experimental research. It is also used as a gas and lubricant additive, antioxidant, and a stabilizing agent for industrial materials. It is also a probable
A study in September 2018 from the British Medical Journal performed an assessment of cancer risk and NDMA contaminated valsartan. Participants included a total of 5,150 Danish patients aged 40 and above, using or initiating valsartan use between January 2012 to June 2017, and without any history of cancer.
Out of 3,625 patients who were not exposed to NDMA, 104 developed cancer. 198 out of 3,450 participants exposed to NDMA were diagnosed with cancer later on. Increased risk for colorectal and uterine cancer was also observed for single cancer outcomes. The study concluded that the results do not imply a markedly increased short-term overall risk of cancer among valsartan users, but suggests studies with longer follow-up.
Patients and affected family members have started to file lawsuits against drug manufacturers of Valsartan as a response to the recall.
In February 2019, lawsuits filed across the country against the manufacturers of Valsartan were consolidated into a multidistrict litigation (MDL 2875) based in New Jersey. This includes 10 combined class actions and 17 individual personal injury class actions with 20 Valsartan manufacturers named as defendants.
There are 46 lawsuits in the MDL as of April 2019.
How Maxwell Law Group Can Help
If you or your loved one suffered from cancer or developed tumors from taking valsartan, Maxwell Law Group can help get you the compensation you deserve. Call (844) 525-7155 or fill out the form below and we’ll investigate your case at no charge to you.
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