FDA Recall: Popular Blood Pressure Drug Valsartan Presents Cancer Risk

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FDA Recall: Popular Blood Pressure Drug Valsartan Presents Cancer Risk

Valsartan is used in many common blood pressure medications to treat high blood pressure and heart failure. Millions of people suffer from high blood pressure in the United States, so when the U.S. Food and Drug Administration issued a recall of tainted valsartan products, it put millions of Americans on alert to see if their life-saving medications could potentially be putting their health at risk. Valsartan-containing medicines manufactured by several leading pharmaceutical companies were recalled because they contained levels of NDMA, a chemical classified as a probable carcinogen. Now, lawsuits are forming against the makers of these commonly used drugs.

The U.S. Food and Drug Administration (FDA) recalled several popular blood pressure medications because they may be contaminated with a potentially cancer-causing chemical. Valsartan is used in a number of generic medications that treat high blood pressure and heart failure. The contaminated batches of valsartan were imported from China and were tainted with  N-nitrosodimethylamine or NDMA, a chemical classified as probably cancerous to humans.

Were you diagnosed with cancer following long-term usage of Valsartan?

A chemical in Valsartan has been linked to various cancers in patients. If you were prescribed Valsartan and later was diagnosed with cancer, you may qualify here for financial compensation.

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The FDA initiated the voluntary recall of valsartan in July 2018, and has since expanded the recall to include several more manufacturers of the drug. In a press release, the federal agency warned patients and healthcare providers of the potential risks of NDMA and said how the product was manufactured could have been the cause of the contamination.

“NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.” — U.S. Food and Drug Administration

Since manufacturing practices could have been at fault, the FDA said it would continue to work with the makers of valsartan to ensure future batches did not contain the same impurity. FDA Commissioner Dr. Scott Gottlieb said the agency was “committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured.”

He continued, “As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

FDA Warning to Patients Taking Valsartan

As thousands of bottles of valsartan-containing blood pressure medications are being taken off the shelves, the FDA advises patients to continue taking their medicine—even if it is part of the recall—until they can get a replacement prescription from their doctor.

Not all valsartan products are being recalled at this time, and many alternative treatment options are available on the market. Patients should speak with their doctor to see if their valsartan prescription is part of the FDA recall and whether or not they need a replacement bottle or different medication from the pharmacist.

Patients can use the following chart provided by the FDA to see if their valsartan prescription medication is being recalled. The FDA has expanded the recall since its initial announcement in July 2018.

This list is continuously being updated and may be expanded further if the FDA finds further evidence of tainted valsartan products from other manufacturers. Check back often to make sure your medication doesn’t contain the impurity that could put you at increased risk for cancer.

To determine if your prescription is part of the recall, patients should look at the drug name an company name on the label of their prescription bottle. If the information is not on the bottle, they should contact the pharmacy that dispensed the medicine.

If a patient’s medicine is included in the recall, the FDA says to follow the instructions provided by the specific company. This information can be found on the FDA’s website. Patients should also contact their health care provider, including the pharmacist that dispensed the medication and the doctor who prescribed it, to see if another valsartan product should be used instead or if there is an alternative treatment option.

Valsartan Cancer Lawsuits

Brandon Sun Health Canada announced a recall on Tuesday after a carcinogen was found in the blood-pressure drug valsartan. (Michael Lee/The Brandon Sun)

Millions of Americans live with high blood pressure and need to take medications to manage their symptoms. When those medications are affected by potentially dangerous impurities, it puts patients at risk for further health problems.

Several manufacturers of valsartan-containing drugs were involved in a voluntary recall initiated by the FDA in July 2018 and that recall has only expanded since. Patients affected by the tainted medications are beginning to file lawsuits against those manufacturers in an effort to recoup the damages they experienced.

Valsartan cancer lawsuits accuse the markers of the valsartan-containing drugs involved in the recall of manufacturing a defective product and failing to warn about its potential risks. If you or a loved one took a valsartan product recalled due to NDMA impurities, you may be entitled to financial compensation. There may be significant payouts or cash settlements to those affected by the drug.

The experienced lawyers and attorneys at Schmidt National Law Group are ready to help you fight for compensation for damages suffered at the hands of greedy pharmaceutical companies that put profit over the health of patients. Call Schmidt National Law Group today at 1-800-631-5656 to see if you qualify for a Valsartan Cancer Lawsuit, or visit nationalinjuryadvocates.com to file a claim now.

FDA Updates List of Recalled Valsartan Products

In August 2018, the FDA expanded its initial recall of valsartan products to include additional manufacturers of the tainted drug. The impure batches of valsartan were originally manufactured in China by Zhejiang Huahai Pharmaceuticals and then supplied to various other pharmaceutical companies who used the contaminated drug in their medications.

Manufacturers involved in the FDA’s recall and their products include:

  • Major Pharmaceuticals – Valsartan
  • Solco Healthcare – Valsartan
  • Teva Pharmaceuticals Industries Ltd. – Valsartan
  • Solco Healthcare – Valsartan/Hydrochlorothiazide (HCTZ)
  • Teva Pharmaceuticals Industries Ltd. – Valsartan/Hydrochlorothiazide (HCTZ)

According to the FDA, the above manufacturers did not meet the standards set by the regulatory agency.

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Not all valsartan products were manufactured using ingredients supplied by Zhejiang Huahai Pharmaceuticals, and the Chinese company has since stopped distributing valsartan in the United States.

The FDA is now working with manufacturers to make sure affected drugs are taken off the shelves before more patients are exposed to the potentially cancer-causing impurity found in the recalled products.

Tainted Valsartan Products a Cancer Risk?

Valsartan products recalled by the FDA were contaminated with a potentially cancer-causing chemical called N-nitrosodimethylamine or NDMA. It is classified as probably cancerous to humans, and patients who suffer from high blood pressure and take valsartan medications to manage their symptoms may have been put at an increased risk of cancer.

NDMA is an organic chemical that can form during industrial and natural processes. It can be produced unintentionally through certain chemical reactions and is a byproduct of some pesticide manufacturing, the making of rubber tires, and fish processing. It  has been used to make rocket fuel, softeners and lubricants, and exposure in high levels may cause liver damage in humans, according to a report by CNN.

NDMA can also be an unintended byproduct of wastewater treatment plants that use certain chemical compounds for disinfection, according to a CBS News report.

The potential cancer risk depends on how much NDMA was present in the contaminated valsartan products. The FDA has worked to determine the amount of NDMA present in the recalled drugs and found it exceeded acceptable levels set by the Environmental Protection Agency. According to CBS News, FDA scientists estimated that “if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of those 8,000 people.”

The World Health Organization (WHO) says NDMA is probably cancerous to humans and wrote in a report there is “conclusive evidence that NDMA is a potent carcinogen” in animals tested in several laboratory studies.

The WHO continued: “NDMA has been classified by IARC [International Agency for Research on Cancer] as probably carcinogenic to humans. The mechanism by which NDMA produces cancer is well understood… There is also ample evidence that NDMA is genotoxic both in vivo and in vitro.”

According to the organization, several case-control studies and one cohort study on NDMA have been performed in humans which suggest that NDMA consumption is positively associated with either gastric or colorectal cancer.

Who is at Risk?

More than 100 million Americans are living with high blood pressure, according to the American Heart Association (AHA). New statistics point to about 103 million adults in the United States that have high blood pressure and are at an increased risk for heart attack and stroke—that’s nearly half of U.S. adults.

Epidemiologist Dr. Paul Muntner, co-chair of the group that wrote the AHA’s Heart Disease and Stroke Statistics—2018 Update, said the prevalence of high blood pressure is expected to continue to increase due to the aging population of the U.S. and higher life expectancies.

The death rate from high blood pressure increased by nearly 11 percent between 2005 and 2015, according to the AHA, and the actual number of deaths rose by almost 38 percent. In 2015, nearly 79,000 people died as a result of high blood pressure.

In addition to leading a healthier lifestyle, people with high blood pressure often take medication to control their symptoms. Some of the most commonly prescribed medications include the ingredient valsartan. Valsartan is a member of the drug class called angiotensin receptor blockers or ARBs.

Because of Valsartan’s widespread use in the United States, millions of people who rely on the medication to control their blood pressure could potentially be at an increased risk for cancer due to their exposure to NDMA. The FDA’s recall began with just one or two manufacturers and, within a month, was expanded to include several more companies affecting thousands of bottles of valsartan.

Visit the FDA’s website to determine whether your valsartan prescription might be part of the nationwide recall.

Alternatives to Valsartan

Patients whose valsartan prescription was recalled by the FDA should continue taking their medication until they speak with their doctor and determine the next course of action. Their healthcare provider may recommend switching to a valsartan product that was not affected by the recall, or they may recommend a different treatment option altogether.

There are many alternatives to valsartan on the market today. If the risk of cancer from recalled batches of valsartan is too much, patients may choose to seek another treatment option.

Valsartan belongs to a class of drugs known as angiotensin receptor blockers or ARBs. There are currently eight different drugs on the market in the same category and patients should speak with their doctors to see if one of these other medications could be a viable alternative for them.

Other ARBs currently on the market include:

  • Eprosartan (generic name)  – Teveten (brand name)
  • Olmesartan (generic name) – Benicar (brand name)
  • Losartan (generic name) – Cozaar (brand name)
  • Telmisartan (generic name) – Micardis (brand name)
  • Candesartan (generic name) – Atacand (brand name)
  • Azilsartan medoxomil (generic name) – Edarbi (brand name)

At least one of these ARB medications has been linked to other health problems in patients. Benicar has been associated with an increased risk for developing a life-threatening gastrointestinal disorder called sprue-like enteropathy. The disorder mimics celiac disease and put sufferers in the hospital due to rapid weight loss and severe dehydration. A settlement in the Benicar litigation was reached in 2017 for $300 million to be paid out to those who experienced intestinal issues after using the drug.

In addition to ARBs, there are medications in other drug classes that can be used to control blood pressure. Patients should speak with their healthcare provider to see which option is best for them.

FDA Continues to Investigate Recalled Products

Since the FDA announced its recall in July 2018, the agency has continued to monitor the situation and ensure all contaminated products are removed from distribution. To protect patient safety, the agency said it would continue to update its statement regarding the recall as more information is made available through its investigation.

“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market,” said FDA Commissioner Dr. Scott Gottlieb.

As the FDA investigates the problem, patients who were exposed to the cancer-causing chemical NDMA can take legal action against the manufacturer of the contaminated product. If you or a loved one took a valsartan product recalled due to NDMA impurities, you may be entitled to financial compensation. Call Schmidt National Law Group today at 1-800-631-5656 to see if you qualify for a Valsartan Cancer Lawsuit, or visit nationalinjuryadvocates.com to file a claim now