Valsartan: Recall, Contamination Risks and Side Effects

Valsartan is a heart medication that primarily treats high blood pressure. Manufacturers recalled many pharmaceuticals containing valsartan between 2018 and 2021 due to dangerous chemical impurities.

Medications containing valsartan may have links to an increased risk of various types of cancer due to exposure to carcinogenic compounds called nitrosamines. Patients who used the medication before the valsartan recalls are now pursuing litigation to hold manufacturers liable for their injuries.

Valsartan is a prescription medication used to treat high blood pressure and heart failure. Manufacturers have sold valsartan under the brand names Diovan and Prexxartan.

Valsartan is part of a class of drugs called angiotensin II receptor antagonists (ARBs), which block natural processes that cause blood vessels to tighten. By blocking these processes, valsartan allows the heart to pump more effectively and for blood to flow more easily.

Drug makers recalled valsartan because the U.S. Food and Drug Administration (FDA) determined that medications like valsartan made with active pharmaceutical ingredients (APIs) from labs in China and India contained dangerous impurities.

A number of FDA recalls have occurred due to problems with valsartan, including the following:

From 2019 through 2021, the FDA tracked recalls for 1,246 lots of valsartan medications. The FDA maintains an updated list of recalled valsartan products, which the agency last modified in late 2021, to alert patients if their medications were part of the recall.

Recalls were not isolated to the United States. In fact, the FDA’s actions only came after 22 other countries issued recalls of 2,300 batches of contaminated valsartan. The recalls were so widespread because global suppliers introduced the impurities before sending APIs to many other companies across different countries.

NDMA is a chemical that forms during natural and industrial processes. The human body creates low levels of NDMA, and it’s also unintentionally produced by chemical reactions in labs. For instance, the wastewater disinfection process may form NDMA as a byproduct.

In addition to the IARC, the U.S. Department of Health and Human Services (HHS) and the Environmental Protection Agency (EPA) classify NDMA as a “probable” or “reasonably anticipated” carcinogen.

In 2018, the European Medicines Agency announced it had detected an average NDMA level of 60 parts per million in valsartan manufactured by certain global suppliers.

NDMA at this level could result in one additional patient developing cancer out of every 5,000 patients taking valsartan in the highest allowable dose (320 mg) each day for seven years.

Before 2018, NDMA contamination was not an expected or known valsartan side effect, so patients who used it did not know about the potential risk of exposure to this potentially carcinogenic substance.

Not all valsartan products were contaminated — only those manufactured by affected labs, including Zhejiang Huahai Pharmaceutical Co. Ltd. in China and Mylan Pharmaceuticals in India.

Even when valsartan isn’t tainted with NDMA, it can cause several different types of side effects. Drug makers, including valsartan manufacturers, must tell patients and health care providers about the side effects of the medications they produce.

Valsartan also carries a black box warning — the FDA’s most serious warning —alerting patients of serious potential risks to unborn babies.

Valsartan recalls were necessary due to the links between NDMA contamination and various types of cancer. Specifically:

The best way to determine if you took recalled valsartan is to check the FDA’s database of recalled lots of valsartan medications. You will need to know your lot number, which you can find:

The affected medications were primarily sold between 2014 and 2018, so it may be unlikely that you still have the medication bottles. However, your medical records and pharmacy records should have the information you need.

If you took recalled valsartan, there are a few steps you can take to protect your health going forward:

You may also wish to file a valsartan lawsuit to hold the drug manufacturers accountable. You can speak with an attorney to explore your options, including joining a multidistrict litigation (MDL) with other valsartan users in a consolidated case.