2018 FDA Updates on Valsartan, FAQS

Fact-Checked

Editors carefully fact-check all Drugwatch content for accuracy and quality.

Drugwatch has a stringent fact-checking process. It starts with our strict sourcing guidelines.

We only gather information from credible sources. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts.

Prescription pills

Federal drug regulators continue to investigate how a cancer-causing chemical contaminated some blood-pressure medicine taken by millions of Americans called valsartan.

The U.S. Food and Drug Administration on July 13, 2018 announced a voluntary recall of more than half of all valsartan prescriptions in the U.S. because some lots contained N-nitrosodimethylamine (NDMA) —  a known carcinogen.

About 3 million Americans take valsartan. The tainted drugs have been on the market since at least 2012, the agency estimates.

Prinston Pharmaceuticals first informed the FDA that its valsartan products contained NDMA and it stopped manufacturing the drug on June 19. The contamination has been linked to a plant in China, though an aggressive investigation is ongoing.

Some lawyers are filing valsartan lawsuits for people who took valsartan and developed colon or stomach cancer.

How High is the NDMA Cancer Risk?

The FDA estimates that if 8,000 people took NDMA-contaminated valsartan at the highest dose of 320 milligrams for four years, they may suffer one additional case of cancer over their lifetimes.

“This estimate represented the highest possible level of NDMA exposure,” the FDA said Aug. 30. “It was a measure of the risk under the most extreme circumstances. Most patients who were exposed to the impurity through the use of valsartan received less exposure than this worst-case scenario.”

A Finnish study in the International Journal of Cancer in 1999 found people who ate food contaminated with NDMA had double the risk of developing colorectal cancer.

What is NDMA?

NDMA is a chemical byproduct of industrial and natural processes. It is a component of rocket fuel, antioxidants and lubricants, the U.S. Environmental Protection Agency said in November 2017.

It also occurs as a byproduct of chlorinating wastewater. So, it may occur in small levels in drinking water and food.

Some foods that may contain NDMA include cured meat, smoked meat, grilled meat and bacon. It may also be in dairy and vegetables.

NDMA can cause cancer in animals. The U.S. Department of Health and Human Services says NDMA is “reasonably anticipated to be a human carcinogen,” according to the EPA.

What Should I Do if My Valsartan is Recalled?

If your valsartan is on the recalled list, do not immediately stop taking your medication. Quitting medication suddenly may increase your risk of stroke and other problems related to high blood pressure.

The FDA recommends contacting your doctor immediately to discuss your treatment options. The agency is also providing a list of valsartan products that are not being recalled.

What Drugs are Included in the Valsartan Recall?

So far, the recall includes generic valsartan drugs and other combination drugs with valsartan as the active ingredient.

The FDA is also investigating other blood pressure drugs in the same class of angiotensin II receptor blockers, including losartan (Cozaar) and olmesartan (Benicar). But, these drugs are not included in the recall.

The following valsartan-containing drug combinations are included in the recall:

  • Valsartan and hydrochlorothiazide (HCTZ)
  • Amlodipine and valsartan
  • Amlodipine, valsartan and hydrochlorothiazide (HCTZ)

Which Manufacturers are Included in the Recall?

Not all manufacturers of valsartan are included in the recall, according to the FDA. For example, the recall does not involve brand name manufacturers of valsartan such as Novartis, the manufacturer of Diovan and Diovan HCT.

Companies in the recall as of Aug. 27 include:

  • Teva Pharmaceuticals labeled as Major Pharmaceuticals
  • Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC
  • Teva Pharmaceuticals USA labeled as Actavis
  • AvKARE (Teva/Actavis)
  • RemedyRepack Inc. (Prinston/Solco)
  • A-S Medication Solutions LLC (Teva/Actavis& Prinston/Solco)
  • Bryan Ranch Prepack, Inc. (Teva/Actavis)
  • HJ Harkins Company Inc. dba Pharma Pac (Prinston/Solco)
  • Northwind Pharmaceuticals (Teva/Actavis)
  • Hetero Labs, Inc. labeled as Camber Pharmaceuticals Inc.
  • RemedyRepack Inc. (Hetero/Camber)
  • AvKARE (Hetero/Camber)
  • Preferred Pharmaceuticals, Inc. (Hetero/Camber)
  • Torrent Pharmaceuticals Limited
  • RemedyPack, Inc. (Torrent)

The FDA updates its list of affected companies, drugs and lot numbers for the valsartan recall on its website. You can also ask your pharmacist if your medication is recalled.

Are There Valsartan Lawsuits?

Some people who took these products are filing lawsuits. Lawyers are currently investigating valsartan cancer claims.

Diagnosed with cancer after Valsartan use? Get a Free Case Review

Contaminated valsartan products may have been on the market since 2012, according to the FDA. Millions of more than 1.5 million Americans may have taken contaminated medication.

In the meantime, the FDA continues to investigate valsartan.

“As we continue to investigate this episode, and develop new information, we will update the public regularly,” FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research director Janet Woodcock said in a joint statement. “We are committed to identifying the root causes of this impurity being found in valsartan, and taking steps to reduce the risk that similar episodes occur in the future.”

  •  
  •  
  •  
Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics, vaccines and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

5 Cited Research Articles

  1. U.S. Food and Drug Safety Administration. (2018, August 30). Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619024.htm
  2. U.S. Food and Drug Safety Administration. (2018, August 24). FDA updates on valsartan recalls. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm
  3. Graedon, J. (2018, August 2). Valsartan Recall Update: How Big is The Problem? Retrieved from https://www.peoplespharmacy.com/2018/08/02/valsartan-recall-update-how-big-is-the-problem/
  4. Knekt, P. et al. (1999). Risk of colorectal and other gastro-intestinal cancers after exposure to nitrate, nitrite and N-nitroso compounds: a follow-up study. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/10074917
  5. EPA. (2017, November). Technical Fact Sheet — NDMA. Retrieved from https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf
View All Sources
Call to speak with a legal expert
Who Am I Calling?

Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.

Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.

(877) 239-9641