Some batches of certain sartan medicines were found to contain nitrosamine impurities, but that did not mean every sartan or every batch was affected. The U.S. Food and Drug Administration (FDA) modeled a worst-case valsartan exposure as one additional lifetime cancer case per 8,000 people taking the highest daily dose with the highest contamination scenario for four years. That figure is not a personal risk estimate. Studies of valsartan users have not found a consistent increase in overall cancer, although some reported associations with particular cancers that do not prove the drug caused them.
What was found in some sartan medicines?
Sartans are angiotensin II receptor blockers (ARBs), a class of prescription medicines used to treat high blood pressure and heart failure. Valsartan, losartan and irbesartan are examples. In summer 2018, the FDA learned that some ARB products contained nitrosamine impurities outside its safety standards.
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The FDA identifies NDMA and NDEA as probable human carcinogens and NMBA as a potential human carcinogen. It says impurities may form when particular chemicals and reaction conditions occur during active pharmaceutical ingredient manufacturing, and may also be related to reuse of materials such as solvents. A hazardous impurity is a reason to control exposure; its presence alone does not establish that a particular patient will develop cancer.
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What did the FDA’s cancer-risk estimate mean?
In 2018, the FDA estimated that one additional lifetime cancer case could occur among 8,000 people taking 320 mg of valsartan daily with the highest contamination scenario every day for four years. The agency described this as a worst-case scenario. It is a modeled population estimate, not a measured count of cancers, an individual patient’s probability, or an estimate that applies equally to every contaminated lot.
The FDA noted that most batches had much lower impurity levels and that a person’s exposure could vary between refills. Its broader guidance says exposure above acceptable limits that persists over long periods may increase risk. It also says daily exposure at or below acceptable intake limits for 70 years is not expected to increase cancer risk. This is a regulatory risk framework, not a calculation of any individual’s exposure or reassurance about every possible exposure.
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Nitrosamines can also occur at some level in food and the environment, according to FDA materials. That context does not make an impurity in a medicine acceptable; regulators set limits to control avoidable exposure.
What have studies of valsartan users found?
Observational studies compare health outcomes among groups; they can identify associations but cannot, by themselves, prove that an exposure caused a cancer. These studies examined valsartan, so their results should not automatically be extended to every sartan, impurity, product or exposure. Their estimates also differ because they used different populations and methods to classify exposure.
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| Study | Population and follow-up | Overall cancer finding | Other reported findings |
|---|---|---|---|
| Denmark, 2018 | Nationwide cohort of 5,150 people; median follow-up 4.6 years. | Adjusted hazard ratio 1.09 (95% confidence interval 0.85–1.41); no evidence of a dose-response relationship (P=0.70). The authors found no indication of a markedly increased short-term overall cancer risk. | The confidence interval leaves uncertainty, and the follow-up limits conclusions about cancers with long latency. |
| Germany, 2021 | Insurance-data cohort of 780,871 people who filled valsartan prescriptions during 2012–2017. | No association with overall cancer was reported. | Hepatic cancer association: adjusted hazard ratio 1.16 (95% confidence interval 1.03–1.31). This is an association, not proof of cause. |
| France, 2022 | Nationwide cohort of 1.4 million valsartan users. | No increase in overall cancer associated with NDMA-contaminated valsartan was reported; adjusted hazard ratio 0.99 (95% confidence interval 0.98–1.00). | The study reported associations with liver cancer (adjusted hazard ratio 1.12, 95% confidence interval 1.04–1.22) and melanoma. Its observational design and exposure classification limit causal conclusions. |
Taken together, these studies do not establish a consistent increase in overall cancer, but they cannot rule out every risk. The liver-cancer associations reported in Germany and France merit careful interpretation; they do not establish that contaminated valsartan caused those cancers. The FDA’s modeled estimate and these observational studies answer different questions: one estimates a specified worst-case exposure scenario, while the others compare outcomes in populations.
How can you check whether your medicine was affected?
In the United States, recall status depends on the product and lot. To identify a medicine, gather these details from the packaging or prescription label:
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- Manufacturer or labeler: The manufacturer may differ from the distributor or labeler shown on the package.
- National Drug Code (NDC): This identifies the listed drug product and package.
- Lot number: Recall status may vary from one lot to another.
- Active ingredients: Check whether the tablet is a combination product containing a sartan.
Use the FDA’s current recall information and ask a pharmacist to help identify or interpret the product details. FDA recall lists are U.S.-specific and can change; a U.S. recall status should not be assumed to apply in another country.
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Should you stop taking valsartan, losartan or another sartan?
No: do not stop a prescription medicine on your own because of a possible nitrosamine impurity. The FDA advises patients with concerns to speak with a health professional about the medicine and treatment options. If you suspect your product is affected, contact a pharmacist to check its specific details and get guidance from your prescriber about what to do. Do not switch medicines, skip doses or try to assess your personal cancer risk without professional advice.
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