Valsartan is the active ingredient in medications used to treat high blood pressure, congestive heart failure, and to improve longevity for those left with ventricular dysfunction following a serious heart attack.
The ingredient aims to constrict blood vessels while simultaneously activating aldosterone, the hormone that plays a central role in the homeostatic regulation of blood, to reduce blood pressure.
Recently, the FDA has announced a voluntary recall of several medicines containing valsartan following the detection of an impurity known as N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen, a substance capable of causing cancer, and was present in medications utilizing Valsartan likely due to the way it was manufactured.
Our Valsartan lawyers are currently investigating cases for patients diagnosed with kidney cancer or liver cancer as a result of taking Valsartan. Recently, the FDA estimated that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the recommended time, there may be one additional case of cancer per 8,000 people.
What Is Valsartan?
Valsartan is a tetrazole derivative and angiotensin II type 1 receptor blocker that is used to treat chronic heart failure, diabetes mellitus, hypertension, left ventricular hypertrophy, post-myocardial infarction, and renal impairment.
It acts as the active ingredient in several types of oral medications that specifically target these conditions, which can lead to additional serious health complications, or even prove fatal. These conditions typically arise when:
- Chronic Heart Failure - occurs when your heart muscle consistently fails to pump blood as well as it should
- Diabetes Mellitus - a chronic lifelong condition that affects the body's ability to use energy found in food and is indicated by high blood sugar levels over a prolonged period
- Hypertension - is a sign of great physical or psychological stress and is indicated by abnormally high blood pressure
- Left Ventricular Hypertrophy - the enlargement and thickening of the walls of your heart's main pumping chamber
- Post-Myocardial Infarction - occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle
- Renal Impairment - indicates sudden and often a temporary loss of kidney function
Valsartan was developed by Switzerland-based pharmaceutical company Novartis, and was primarily sold under the brand name Diovan.
Diovan currently holds the largest market share for an oral high-blood pressure medication and has been administered in the treatment of hypertension and high blood pressure in children of 6 years or older, adolescents, and adults dating back to December 2008.
How Does Valsartan Work?
Valsartan is a rapidly absorbed oral medication typically administered in tablet form. It is most commonly used to treat a variety of cardiac conditions including hypertension, diabetic nephropathy, and heart failure. The medication lowers blood pressure by selectively inhibiting the actions of angiotensin II— a labile vasoconstrictor which is found in many tissues such as vascular smooth muscle and adrenal glands.
This process works intimately with the kidneys and works to inhibit aldosterone-secreting effects that result in a decrease in vascular resistance and blood pressure. The inhibition of aldosterone secretion may inhibit sodium and water reabsorption in the kidneys while simultaneously decreasing potassium excretion.
Valsartan is classified as an angiotensin II receptor blocker (ARB) and works to block a substance in the body that causes blood vessels to tighten. The medication relaxes blood vessels and allows blood to be more easily distributed throughout the body, consequently lowering blood pressure and increasing a supply of oxygen to the heart.
Valsartan is administered in various dosages that compound by a factor of two from the preceding dosage—beginning with a dosage of 40mg. The dosages are:
- 40 mg Oral Tablets
- 80 mg Oral Tablets
- 160 mg Oral Tablets
- 320 mg Oral Tablets
In addition to its normal dosage, Valsartan can be administered with the additives hydrochlorothiazide and amlodipine besylate which works to reduce the reabsorption of electrolytes in the kidneys, in addition to the reduction of vascular and myocardial contractions.
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.
According to the EPA, NDMA is a B2 probable human carcinogen who's classification is based on the induction of tumors at multiple tissue sites, and by several different routes of exposure. The EPA further states that the oral route, including the consumption of contaminated food and water, is the primary human exposure pathway for NDMA. Tumors that developed as a result of NDMA exposure occurred primarily of the liver, respiratory tract, kidney, and blood vessels.
Potential symptoms of overexposure to NDMA include:
- Abdominal Cramps
- Enlarged Liver
- Severe Liver Damage
- Reduced Function of the liver, kidneys, and lungs
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.
Did The FDA Approve Valsartan?
Valsartan and the primarily associated drug Diovan capsules and tablets were approved by the FDA on August 14th, 2002 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—citing extensive pediatric and adolescent studies.
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.
Because of this approval system, patients and physicians have had to rely on post-market surveillance to detect issues and defects, rather than preemptive testing, or safety precautions in the manufacturing process that would have guaranteed the absence of cancer-causing substances from invading the medications.
Complications Caused By Valsartan & NDMA?
- Damage of the liver and kidneys
- Reduced function of the liver and kidneys
- Tumors at multiple tissue sites including the liver, respiratory tract, kidney, and blood vessels
Additional reported side effects include but are not limited to:
- 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
Further studies have linked Valsartan to renal impairment, in addition to dose-related orthostatic hypotension, rash, respiratory tract disorders, diarrhea, and impotence. The reporting on the incidence of side effects continues to be ongoing as the FDA publishes additional information.
Criteria For Filing A Valsartan Lawsuit
Our dangerous drug attorneys are investigating claimants who have suffered the following symptoms as a result of NDMA-tainted Valsartan products:
- Kidney cancer diagnosis
- Liver cancer diagnosis
- Valsartan-related tumors
Can I File A Valsartan Lawsuit?
Our award-winning Valsartan attorneys can help you if you or a loved one developed kidney or liver cancer by taking Valsartan.
We have the experience necessary to take on powerful pharmaceutical manufacturers that distribute Valsartan. We do not charge any legal fees unless you receive a settlement, and we pay all of the case costs.
When we take on a case, we handle it from start to finish. We work tirelessly to get you the compensation you deserve.
Our No-Fee Promise On Valsartan Cases
You can afford to have our great team of lawyers on your side. When you choose us, it literally costs nothing to get started. We promise you in writing:
- No money to get started
- We pay all case costs and expenses
- No legal fees whatsoever unless you receive a settlement
- Phone calls to our office are always free
Contact Our Valsartan Lawyers & Start Your Claim
Our Valsartan lawyers will help you file your lawsuit. There are three ways to get started on your case:
- Submit the Free Case Review Box on this page and we will contact you shortly.
- Chat with our online intake specialist and we will call you for more information.
- Call (800) 606-1717 any time of day to tell us about your case.
We will listen to your story and answer your questions. If you have Valsartan claim, we will start investigating immediately.