Valsartan: Recall, Contamination Risks and Side Effects

Valsartan is a drug that treats high blood pressure and heart failure. 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 cancer due to exposure to carcinogenic compounds called nitrosamines. Some patients who used the drug before the recalls have filed lawsuits.

Valsartan is a prescription medication used to treat high blood pressure and heart failure. It is sometimes sold under the brand names Diovan or Prexxartan.

Valsartan is part of a class of drugs called angiotensin II receptor antagonists. These medications block angiotensin II, a hormone in your body that causes your blood vessels to narrow. This lets your heart pump more effectively and your blood flow more easily.

Valsartan can cause several different side effects, but most are mild. They can include headaches, dizziness, nausea and vertigo.

Most side effects will resolve on their own after you’ve taken valsartan for a while.

While rare, valsartan does come with dangerous side effects like allergic reactions, kidney problems and pregnancy complications.

Alert your doctor immediately if you think you are having a serious reaction to valsartan.

Allergic Reactions Associated With Valsartan

Valsartan may cause serious allergic reactions. These can be extremely dangerous and life-threatening, requiring urgent medical assistance.

The following symptoms could indicate you are having an allergic reaction to valsartan:

In children, signs of an allergic reaction to valsartan may include lack of responsiveness, unusual limpness, difficulty lifting their head or problems focusing on your face.

If you are allergic to valsartan, you might also experience severe skin swelling called angioedema. The drug’s label advises against retaking valsartan if you have this reaction.

Valsartan and Kidney or Potassium Level Problems

You may develop kidney problems or have increased levels of potassium in your blood if you take valsartan. The risk of these complications can be higher if you have heart failure or existing kidney issues.

Weight gain and swelling in your ankles, face, feet or hands are symptoms of kidney impairment. Inform your doctor if you have a kidney or heart condition before taking valsartan.

Pregnancy Side Effects of Valsartan

Valsartan has a black box warning, which is the U.S. Food & Drug Administration’s most serious warning, alerting patients that the drug can cause injury or death to developing fetuses.

You shouldn’t take valsartan if you are pregnant or plan to get pregnant. Stop taking valsartan and talk to your doctor if you find out you’re pregnant.

Doctors also advise against taking valsartan while breastfeeding because it is unknown whether the medication passes to the newborn through breast milk. It’s best to discuss alternative medications with your doctor until your baby can eat solid foods.

Other Reported Valsartan Side Effects

Other reported side effects of valsartan include sexual dysfunction, weight gain and hair loss. However, there is little evidence to support that taking the drug may cause these issues.

While Valsartan’s label does mention that weight gain could be a kidney-related side effect, sexual function issues and hair loss are not listed as potential risks.

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

From 2019 through 2021, the FDA tracked recalls involving 1,246 lots of valsartan medications. The FDA maintains an updated list of recalled valsartan products to alert patients if their medications were part of the recalls.

Recalls were not isolated to the United States. There were 22 other countries that issued recalls for 2,300 batches of contaminated valsartan. The recalls were widespread because global suppliers introduced the impurities before sending APIs to other companies worldwide.

NDMA was at the center of many valsartan recalls. It 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.

The International Agency for Research on Cancer, the Environmental Protection Agency and the U.S. Department of Health and Human Services 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.

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, were impacted.

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

Valsartan Contamination and Cancer Risk

Valsartan recalls were necessary due to the scientific links between NDMA contamination and an increased risk of cancer.

For example, a study published in the Journal of the American Heart Association found a link between exposure to NDMA in valsartan and an increased risk of liver cancer and melanoma (a type of skin cancer).

A study published in Deutsches Ärzteblatt International found that NDMA-contaminated valsartan could increase patients’ risk of liver cancer. Additionally, a study published in The BMJ found that NDMA exposure increased the risk of colorectal and uterine cancers.

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 the lot number of the medication you took, which you can find:

• By checking the bottle or vial, if you have any remaining pill bottles at home. The lot number is typically by the barcode or under the dosing instructions.
• By contacting your pharmacy or doctor if you no longer have the bottles.

The affected medications were primarily sold between 2014 and 2018, so you might not have 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:

• Discuss screening or health monitoring with your doctor to watch for early signs of cancer.
• Report any concerning symptoms to your doctor immediately so you can undergo proper testing.
• Save your prescription records, pill bottles and other medical documents.

If you were diagnosed with cancer after taking valsartan, you may want to file a valsartan lawsuit. You can speak with an attorney to explore your options.