Valsartan and Cancer

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In July 2018, several lots of generic valsartan medications — primarily prescribed to treat high blood pressure and heart failure — were recalled following the discovery of a probable carcinogenic impurity. This initial voluntary recall prompted an investigation by the U.S. Food and Drug Administration (FDA). Through the investigation, the FDA identified two other probable cancer-causing impurities in the same class of drugs as valsartan (e.g. angiotensin II receptor blockers, or ARBs). Subsequently, in the last year, many more contaminated batches of ARBs — including valsartan, losartan, and irbesartan — were recalled as the investigation continues.

The discovery of these contaminants has caused concern among American patients who now question the safety of their blood pressure medications due to the possibility of an increased risk of cancer.

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Cancer-Causing Impurities

Out of the three probable carcinogens that prompted the recall of blood pressure drugs during the last year, only two were found in valsartan medications — N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).

N-nitrosodimethylamine (NDMA)

NDMA prompted the first valsartan recalls in 2018. The U.S. Environmental Protection Agency (EPA) classifies NDMA as a probable human carcinogen based on tumor growth recorded in animal studies. Exposure to NDMA in large quantities may also cause severe physical symptoms like vomiting, headaches, dizziness, fever, nausea, jaundice and liver damage.

N-Nitrosodiethylamine (NDEA)

Like NDMA, NDEA is considered a probable human carcinogen based on its carcinogenicity in animal studies.

Valsartan Cancer Risks

When considering valsartan and cancer risks, patients should note that any cancer risks attributed to valsartan are associated with contaminated batches of the drug. The probable human carcinogens found in some lots of valsartan-containing drugs may cause cancer, but the drug itself does not.

Additionally, not all valsartan medications or manufacturers were included in the recalls. For example, the brand name valsartan drug Diovan was not impacted by the impurities or recalls. Patients and consumers can visit the FDA’s Angiotensin II Receptor Blockers (ARB) Recall Database to determine if their blood pressure medication was named in the recall.

Understanding the Estimated Risk

During their investigation, the FDA estimated the risk of developing cancer after taking valsartan contaminated by NDMA. They initially found the risk to be relatively low, estimating one additional cancer diagnosis for every 8,000 patients taking the highest dose of contaminated valsartan for four years.

The FDA estimated an even lower risk of cancer for patients taking valsartan contaminated with NDEA. The agency estimated that out of 18,000 people taking the highest dose of contaminated valsartan for four years, one additional case of cancer may result. Smaller amounts of NDEA were found in blood pressure medications compared to the levels of NDMA found, which may explain the lower relative risk of cancer for NDEA contaminated lots.

In August 2019, the FDA released a statement pertaining to the agency’s earlier estimations. The statement stresses that the estimations reflect a scenario involving the highest exposure level, according to FDA-cleared indications for the drugs. The actual risk a patient may face will likely be significantly lower.

Valsartan-Related Cancers

Despite the FDA’s low estimates regarding valsartan cancer risks, more than 100 lawsuits have been filed against several pharmaceutical companies claiming the contaminated drug was responsible for their cancer diagnosis. Law firms are currently investigating cases for the following types of cancer:

What to Do if You’re Taking a Recalled Valsartan Medication

First and foremost, if you’re currently taking a recalled valsartan medication, don’t stop taking the drug before speaking with your doctor or healthcare provider. Valsartan treats serious health conditions, making it unsafe for patients to stop taking the drug without an alternative treatment method available. Talk to your doctor about a replacement prescription or an alternative treatment option.

You can also speak with your pharmacist or call the drug manufacturer to determine the best method of disposal for the recalled medication. In some cases, you may be eligible for a refund.  However, every drug manufacturer handles recalls differently.

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