Does Valsartan Cause Cancer? 2025 Legal Guide
Valsartan, a widely prescribed medication for high blood pressure and heart failure, has come under intense scrutiny in recent years. Its promise of lowering cardiovascular risk for millions has been overshadowed by concerns linking certain batches to increased cancer risk. Media coverage, product recalls, and a wave of lawsuits have kept patients and healthcare providers on edge. But does valsartan itself cause cancer, or is the story more complicated?
Understanding Valsartan
Initially developed as a brand-name drug called Diovan, valsartan belongs to a class of medications known as angiotensin II receptor blockers (ARBs). It’s often prescribed to:
- Control high blood pressure (hypertension)
- Prevent strokes and heart attacks
- Treat certain types of heart failure
The underlying science is well-established: blocking angiotensin II helps relax blood vessels, decreasing blood pressure and easing strain on the heart. For decades, valsartan earned a reputation for being effective, safe, and tolerable for long-term use with minimal side effects.
The Contamination Controversy
The shock did not come from the drug’s intended use, but rather from impurities found in the manufacturing process. In June 2018, the U.S. Food and Drug Administration (FDA) announced that some batches of generic valsartan contained nitrosamines, specifically N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).
These compounds are not supposed to be present in pharmaceuticals. Both NDMA and NDEA are classified as probable human carcinogens. That classification isn’t reached lightly; extensive studies have shown that high exposure to these substances can increase cancer risk in animals, and by extension, likely in people.
How Did Contamination Occur?
Most affected valsartan products were manufactured by overseas companies, particularly Zhejiang Huahai Pharmaceutical in China. Changes in their production methods led to the unintentional formation of nitrosamines.
The FDA estimated that, in some cases, daily exposure to contaminated valsartan over several years could marginally increase a person’s cancer risk. Their projections suggested one extra case of cancer per 8,000 people taking the highest dose every day for four years.
Below is a summary table of key events:
| Year | Event | Details |
|---|---|---|
| 2018 | First recalls announced | NDMA and NDEA found in specific batches of valsartan |
| 2019 | Broader recall and investigation expanded | More manufacturers and products included in recalls |
| 2020 | Legal claims against manufacturers accelerated | Lawsuits file alleging harm from recalled valsartan |
| 2021 | Independent studies published | Research confirms presence of nitrosamines in some products |
| 2022 | Manufacturing and regulatory changes implemented | Tighter controls on impurity testing |
| 2023 | Ongoing litigation and scientific assessment | Additional health risk analyses released |
Does Pure Valsartan Cause Cancer?
It’s important to separate the drug itself from contaminated versions. Clinical data before 2018, when contamination was first identified, do not show evidence that valsartan, in its intended pure form, increases cancer risk.
In fact, years of research and post-market surveillance showed valsartan to be free of carcinogenic properties. The controversy centers specifically on contamination with nitrosamines during manufacturing—not on valsartan itself.
The Role of NDMA and NDEA
Both NDMA and NDEA are present in the environment at very low levels. They can be found in smoked meats, drinking water, and even some vegetables. The trouble comes from chronic exposure to higher concentrations, which can increase the risk of liver damage, in addition to liver, kidney, and gastrointestinal cancers.
When found in medication at doses above FDA-recommended limits, NDMA and NDEA pose a heightened risk. This spurred urgent recalls and rapid investigation around the world. Regulators worldwide — including in Europe, Canada, and the United States — issued statements and halted distribution of affected lots.
What Does the Science Say?
Several peer-reviewed studies, along with regulatory assessments, examined cancer incidence among individuals taking potentially contaminated valsartan. The consensus is nuanced:
- Short-term exposure is unlikely to result in a detectable increase in cancer risk.
- The primary concern lies with chronic, high-dose exposure over years.
- Not every bottle of valsartan was contaminated; most, especially brand-name products, were found to be free of nitrosamines.
A 2021 study published in the British Medical Journal followed a large cohort of valsartan users and concluded that the increase in cancer risk, even among those who took contaminated batches, was measurable but small. More importantly, they emphasized that patients should not abruptly stop taking the medication, as untreated hypertension itself dramatically elevates risks of stroke, heart attack, and death.
Legal Implications and Patient Rights
The discovery of carcinogenic impurities, which causes cancer and raises concerns about potential side effects, sparked a flood of lawsuits across the United States. Key claims allege that some manufacturers:
- Failed to adequately test for impurities
- Did not notify regulatory bodies promptly
- Failed to recall their products as soon as they became aware
The demand for accountability is understandable. Patients have a right to expect that the medications prescribed are both safe and carefully monitored.
Law firms, including ours, have been contacted by individuals questioning their own exposure and seeking guidance on potential legal remedies. The landscape is still shifting as scientists, the FDA, and attorneys gather more information. Current litigation focuses on:
- Compensation for those diagnosed with cancer after exposure
- Medical monitoring for at-risk individuals
- Ongoing reimbursement for switching to alternative therapies
Recognizing Contaminated Lots
Patients who took valsartan between July 2014 and July 2018 were most at risk, particularly those who used certain generic brands. The FDA and pharmacy boards published detailed lists of affected products, lot numbers, and manufacturers. Individuals can check with their pharmacist or healthcare provider to review their prescription history and confirm whether they may have been exposed.
Signs You May Have Been Affected
It’s not always easy to know if your medication was contaminated. Look for:
- Notification letters from your pharmacy or manufacturer
- Recall information provided during medical visits
- Lot numbers printed on prescription bottles corresponding with those on the FDA recall list
If you believe you may have been exposed, discuss cancer screening, potential replacement medications, and medical monitoring with your healthcare provider.
Should You Keep Taking Valsartan?
The FDA, American Heart Association, and countless cardiologists have all echoed the same advice: do not stop taking valsartan or any ARB medication without discussing the switch with your doctor.
Uncontrolled hypertension and heart failure are far more dangerous, and abruptly stopping medication can trigger serious — even life-threatening — complications. The vast majority of valsartan currently available on the market is free of nitrosamine contamination, thanks to improved oversight and manufacturing protocols.
What Alternatives Exist?
There are several options if you are concerned about valsartan, including switching to:
- Other ARBs (losartan, irbesartan, candesartan)
- ACE inhibitors (lisinopril, enalapril, ramipril)
- Calcium channel blockers (amlodipine, diltiazem)
Well-trained clinicians can help select a suitable alternative, taking into account your health history, potential allergies, and personal preferences.
Ongoing Monitoring and Regulatory Response
Ongoing reform within the pharmaceutical manufacturing sector, especially for overseas suppliers, now prioritizes rigorous impurity screening and better transparency. Regulatory agencies have enhanced oversight and updated guidance to prevent similar incidents from recurring.
Inspections are now more frequent. Random batch testing, previously sporadic for generic drugs, is now standard practice for many firms. These changes should give patients added peace of mind as they review their daily medications.
Frequently Asked Questions
Can I sue if I took contaminated valsartan? You may have a case if you can demonstrate that you took affected lots and subsequently developed cancer, as the contamination included impurities that causes cancer, or liver damage, particularly of the liver, kidney, or digestive tract. Legal timelines vary, so seeking legal counsel promptly is important.
How much compensation is possible? Settlements and verdicts differ depending on medical expenses, severity of illness, and whether negligence can be demonstrated against manufacturers.
Does every valsartan product contain NDMA or NDEA? No. Only certain lots, identified in recall notices, were found to contain these impurities.
Is it still safe to use valsartan today? Yes. Current supplies are subject to higher testing standards and ongoing regulatory review.
What Patients and Families Can Do Right Now
Anyone with concerns about historical valsartan exposure can:
- Request pharmacy records to check prescription history
- Review recall information from the FDA website
- Seek medical evaluation and cancer screening, if appropriate
- Consult an attorney to discuss rights and potential compensation
The valsartan case stands as a reminder of the importance of transparency, regulatory vigilance, and patient advocacy in the ongoing relationship between drug manufacturers and the public. With improved safeguards now in place, trust can gradually be restored, but patient vigilance and informed medical decision-making remain essential. To learn more about the valsartan cancer lawsuit we encourage you to view our page dedicated to valsartan litigation. At Garrett, Walker, Aycoth & Olson, Attorneys at Law we’re here for you and if you’ve been injured as a result of a medication or someone else’s negligence our injury attorneys have your back and will fight for you!