Valsartan is a tetrazole derivative and angiotensin II type-1 receptor blocker that is the active ingredient in medications used to treat a variety of heart defects such as chronic heart failure, hypertension, left ventricular hypertrophy, and post-myocardial infarction. It was developed by Switzerland-based pharmaceutical company Novartis and is primarily distributed under the brand name Diovan.
Valsartan is administered in oral tablet or capsule form with the smallest dose being 40 mg and the largest being 320 mg. The capsules work to reduce the reabsorption of electrolytes in the kidneys, in addition to the reduction of vascular and myocardial contractions in order to improve blood flow and reduce the risk of heart complications.
Recently, the FDA has announced a voluntary recall of several medications that utilize valsartan as the primary ingredient following the detection of a probable human carcinogen, a substance capable of causing cancer, known as N-nitrosodimethylamine (NDMA). NDMA was discovered in medications containing valsartan likely due to a manufacturing error. To learn more and see if you are eligible for a claim, contact a Valsartan lawyer today.
What is NDMA?
NDMA is a semivolatile organic chemical that forms in both industrial and natural processes, and although it is not produced in pure form or commercially used in the United States, it can be unintentionally produced from industrial sources through chemical reactions.
Animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidney, and respiratory tract. It can also be potentially harmful to humans in certain quantities. Exposure to high levels can cause liver damage and is a probable human carcinogen, according to the US Department of Health and Human Services.
According to the EPA, NDMA is a B2 probable human carcinogen whose classification is based on the induction of tumors in the liver, respiratory tract, kidney, and blood vessels. The FDA further estimates that consuming up to 96 nanograms of NDMA per day would result in at least one additional case of cancer for every 100,000 people.
Valsartan contaminated with NDMA has been found to cause several serious symptoms and side effects. The controversial drug is being recalled in 22 countries because it contains a chemical that poses a potential cancer risk, specifically kidney and liver cancer. Anyone who has been harmed by Valsartan should contact a trustworthy lawyer and discuss their legal rights.
Complications of NDMA-Contaminated Valsartan
Potential symptoms of overexposure to NDMA include:
- Abdominal Cramps
- Enlarged Liver
- Severe Liver Damage
- Reduced Function of the liver, kidneys, and lungs
Other side effects of Valsartan that should be documented for an attorney include:
- Bloody or brown urine
- Decreased frequency of urine
- Irregular heartbeat
- Lower back or side pain
- Numbness or tingling in the hands, feet, or lips
- Sudden trouble with swallowing or breathing
Reduced Function Of Liver And Kidneys
Valsartan is meant to treat a variety of cardiac conditions—primarily hypertension and cardiac failure. The medication does so by inhibiting the actions of angiotensin II — a labile vasoconstrictor that is found in many tissues such as vascular smooth muscle and adrenal glands.
This process utilizes kidney function to inhibit aldosterone-secreting effects that result in a decrease in vascular resistance and blood pressure. By inhibiting aldosterone secretion, the kidneys may also inhibit sodium and water reabsorption at the same time decreasing the excretion of potassium.
In addition to reduced renal function, Valsartan is broken down by the liver. In patients with existing liver disease or reduced liver function, the medication may build up in the body and cause these conditions to worsen.
Tumors At Multiple Tissue Sites
According to the EPA, NDMA is a B2 probable human carcinogen whose classification is the result of the discovery of tumors at multiple tissue sites.
Although these tumors have been discovered through several routes of exposure, the primary route has been oral consumption—a standard method of administering medications that utilize Valsartan as the primary ingredient. Tumors that developed as a result of NDMA exposure occurred mainly in the liver, respiratory tract, kidney, and blood vessels.
Kidney And Liver Cancer
As mentioned, the EPA classifies NDMA as a carcinogen—a cancer-causing substance. Additionally, the FDA estimates that if 8,000 people took the highest valsartan dosage of 320 mg from the recalled batches daily for the recommended time, there may be one additional case of cancer per 8,000 people.
If you or a loved one developed kidney or liver cancer while taking Valsartan, our dangerous drug attorneys will begin investigating immediately.
Kidney cancer is a broad term used to categorize four forms of cancer – renal cell, transitional cell, sarcoma, and Wilms tumor – that originate in the kidneys. Healthy individuals have two kidneys, bean-shaped organs, located behind the abdominal organs on either side of the spine.
These organs clean the blood, turning the removed waste into urine to be disposed of. In addition to serving as a bodily filter, the kidneys produce hormones responsible for controlling blood pressuring and triggering the production of red blood cells by the bone marrow.
Regardless of the specific type of kidney cancer, most cancerous growths are detected before metastasizing to other parts of the body. When caught in the early stages the cancer is often able to be treated rather successfully.
Successful treatment efforts are vital as the amount of kidney cancer cases has been steadily increasing over recent years. However, it is unknown if this indicates cancer developing more frequently or more cases of it being detected sooner.
Regardless of why kidney cancer numbers have seen a rise in recent years, it is reported that now almost 63,000 people are diagnosed each year with more than 14,000 other victims succumbing to a kidney cancer-related death.
According to the American Cancer Society these numbers make kidney cancer one of the ten most common cancers in both men and women. However, most diagnosed cancers occur in older individuals, rarely discovered in those under 45 with an average diagnosis age of 64.
Liver cancer is a dangerous form of cancer that begins in the cells of the liver. The liver, located in the upper-right area of the abdomen, is responsible for creating proteins, breaking down damaged blood cells, and the body’s metabolic process.
Cancer can originate and develop as several different sub-categories of liver cancer including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and hepatoblastoma. However, the most common of these forms is by far hepatocellular carcinoma which constitutes over 50% of all diagnosed cases of liver cancer.
A common misconception held by those researching liver-based cancers is what qualifies as liver cancer. It is possible for cancer to affect the liver but not be considered or treated as a form of liver cancer. This occurs when cancer arrived at the liver by the metastatic process in which it originated in another area of the body and then spread to the liver.
While this form of cancer may not qualify as a true form of liver cancer, metastatic cancer affecting the liver is far more common than cancer originating in the liver.
When not considering metastatic cancer cases, liver cancer routinely finds itself in the top-10 lists for most often diagnosed and lowest survival rates among cancers. Nearly 40,000 Americans are diagnosed with liver cancer every with over 27,000 deaths occurring in that same time period.
The American Society of Clinical Oncology (ASCO) reports that when broken down, these numbers place liver cancer as the tenth most common cancer among men in addition to being the fifth most deadly. Regarding women liver cancer cases, the disease ranks as the eighth most common cause of cancer-related death.
Have Pharmaceutical Companies Recalled Valsartan?
The leading drug-containing Valsartan as the active ingredient known as Diovan capsules and tablets were approved by the FDA on Aug. 14, 2002, and were filed under the Novartis Pharmaceuticals Corporation.
The FDA granted Valsartan approval based on the treatment of heart failure in patients who are intolerant to the angiotensin-converting enzyme inhibitor.
However, a recent recall of Valsartan was issued on July 17, 2018, based on the discovery of the cancer-causing substance known as N- nitrosodimethylamine (NDMA). The pharmaceutical distributors cited in the recall are:
- Major Pharmaceuticals
- Novartis Pharmaceuticals
- Solco Healthcare
- Teva Pharmaceuticals Industries Ltd.
Additionally, the following re-packagers are expected to recall Valsartan containing products:
- H. J. Harkins Company Inc. (this company was not originally included on either list)
- Lake Erie Medical, doing business as Quality Care Products LLC
- NuCare Pharmaceuticals Inc.
- Northwind Pharmaceuticals
- Proficient Rx
- Bryant Ranch Prepack Inc.
Pharmacies in the UK are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare. The recall involves about 2,300 batches that were sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.
As an attorney could discuss, recalls of medications including Valsartan are ongoing, but patients who have taken the recommended dosages of Valsartan daily have been reported to have developed serious complications as a result.
Find a Dedicated Valsartan Attorney
Call a Valsartan lawyer today if you have been harmed by this dangerous drug. We can answer your questions, explain your rights, and guide you through each step of the legal process to demand justice and fair compensation.