Valsartan, a prescription drug product that was first sold under the trade name Diovan, is used to treat high blood pressure and congestive heart failure and to extend the life spans of heart attack patients. Manufacturers began to produce generic forms of valsartan products after 2012, when the drug’s patent expired. In 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of valsartan drugs from at least one of those generic manufacturers because the drugs from that source contained a carcinogenic byproduct known as NDMA. After stepping up its investigation, the FDA discovered that some valsartan drugs contained a second carcinogen known as NDEA.

The pharmaceutical drug liability lawyers at Showard Law Firm in Arizona represent patients who have been exposed to increased cancer risks from their use of tainted valsartan products. We caution our clients that valsartan (the active ingredient in the drug product) itself is not the problem and that you should not discontinue a valsartan prescription drug regimen without first consulting with your physicians and pharmacists. If, however, you have been using a valsartan drug product that includes any carcinogenic impurities such as NDMA or NDEA, you may well have an elevated valsartan cancer risk.

Does Valsartan Cause Cancer?

Valsartan is one of a class of drugs known as angiotensin II receptor blockers, or ARBs. Valsartan works by preventing a specific kind of protein from constricting blood vessels. A person’s blood pressure will go down when his or her blood vessels are more open and less constricted. Under FDA guidelines, valsartan by itself is safe and effective, and there is no evidence that valsartan causes cancer apart from impurities that may be included along with valsartan in a drug product.

The FDA issued its valsartan recall after it determined that certain generic manufacturers in China and India had failed to fully purify the valsartan drugs they produced, leaving trace quantities of NDMA or NDEA in those drugs. These impurities are organic chemicals that have multiple different uses in food and fuel production. The Environmental Protection Agency classifies NDMA and NDEA as probable human carcinogens. A person’s exposure to regular amounts of NDMA or NDEA may increase that person’s risk of developing cancer.

What Kind of Cancer Do Valsartan Drugs Cause? 

Laboratory animal studies on long-term exposure to NDMA and NDEA suggest that greater doses of these impurities can cause liver toxicity, fibrosis, scarring, and liver tumors. Researchers have concluded from those animal studies that exposure to high levels of these impurities can cause similar types of liver damage in humans.

Patients whose livers are compromised from other diseases are likely at a higher valsartan impurity cancer risk than healthy patients. If those patients have been using valsartan blood pressure or heart disease drugs for an extended period of time, they should consult with their physicians to determine if they should be monitored more closely for liver cancer or other cancer pathologies. 

Are There Other Valsartan Side Effects?

Routine valsartan side effects are comparable to those of other prescription drug products, including placebos, and include conditions such as:

• Dizziness
• Low blood pressure
• Gastric distress
• Joint or back pain
• Fatigue
• Viral and respiratory infections

As with all unusual symptoms, patients who regularly use a valsartan drug and who experience extended bouts of side effects should consult with their physicians. The occurrence of side effects is not an indication of a heightened valsartan cancer risk. Nonetheless, a physician might be better able to diagnose a problem or prevent that problem from materializing when a patient is more aggressive with respect to any adverse reactions to a prescription drug.

Are Drug Manufacturers Obligated to Issue Valsartan Cancer Warnings?

Drug product regulations require manufacturers to warn patients of a product’s hidden risks and to give patients instructions on the proper use of the product.  Manufacturers have a greater burden to warn patients when:

1. A drug product presents a danger that is known by the manufacturer
2. That danger is present even when the product is used properly
3. That danger is not immediately obvious to the user

Manufacturers or distributors of valsartan drug products that contain cancer-causing impurities might have run afoul of these obligations. Valsartan lawsuits have been filed both in and outside of the United States, and the facts that come to light in those lawsuits may well verify that some valsartan drug product manufacturers and distributors were not in compliance with applicable regulations. In that case, patients who used contaminated valsartan drugs may have an opportunity to claim damages to compensate them for the increased cancer risks that they face.

Call Showard Law Firm for Answers to Your Valsartan Cancer Questions

Showard Law Firm advocates for patients throughout the United States who have been exposed to heightened cancer risks and other dangers from tainted pharmaceutical products. If your physician prescribed a valsartan drug to treat your high blood pressure or congestive heart disease problems, and you subsequently developed cancer, please call our law offices as soon as possible. We will review your prescription and help you determine if the supplier of your valsartan product is on the list of manufacturers or distributors whose drugs have been recalled. We will also represent you in any claims for damages that you may have against the parties that carelessly allowed your prescription to be tainted by carcinogenic impurities and that failed to warn you of the risks you were taking when you started using those drugs.

Additional Valsartan Cancer Risk Resources:

1. cnn.com: Valsartan Recall: 4 Things Patients Should Know. https://www.cnn.com/2018/07/19/health/valsartan-recall-explainer/index.html
2. fda.gov: FDA Updates on Valsartan Recalls. https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm
3. webmd.com: More Drug Makers Tagged as Valsartan Recall Grows. https://www.webmd.com/heart-disease/news/20180813/more-drug-makers-tagged-as-valsartan-recall-grows

 

 

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