Zantac Heartburn Drug May Increase Risk of Cancer

Unacceptable levels of NDMA, a known probable carcinogen, has led to recalls of Zantac after decades on the market. If you took Zantac regularly for years, it may be linked to certain cancer diagnoses. If so, the manufacturers of Zantac should compensate you for your illness.
Speak to an Attorney Now

What Is Zantac?

Zantac (ranitidine) is a popular heartburn medication. Approved in the 1980s, it was one of the first drugs to reach $1 billion in sales. It is used by many millions of people a year and is available both over-the-counter and by prescription.(1) (2)

As an over-the-counter drug, Zantac is approved for: (3)

  • Heartburn associated with acid indigestion.
  • Prevention of heartburn associated with acid indigestion caused by some foods and drinks.

At prescription strengths, Zantac is also approved to treat: (4)

  • Ulcers.
  • GERD (gastroesophageal reflux disease).
  • Erosive esophagitis.
  • Zollinger-Ellison syndrome and other hypersecretory conditions.

How It Works

Zantac belongs to a class of drugs called H2-receptor antagonists, or H2 blockers. H2 blockers reduce the amount of acid produced in the stomach.

Stomach acid is essential to digestion, but if stomach acid backs up into the esophagus, it can cause heartburn or acid reflux. (5)

Stomach acid is produced by specialized cells, called parietal cells, found in the lining of the stomach. These cells are partially activated by histamine, a molecule that serves many functions in the body, including secreting gastric acid to help digest food. (6) (7)

Histamine binds to histamine receptors in parietal cells, initiating a chain of chemical reactions that results in the secretion of hydrochloric acid. (8)

H2 blockers bind to histamine-2 receptors in parietal cells. This “blocks” the receptors from binding histamine, preventing the stimulation of acid secretion. (9)

Zantac Compared to Proton Pump Inhibitors (PPIs)

Proton pump inhibitors (PPIs) are another type of stomach acid reducer.

Brands of PPIs include, but are not limited to:

PPIs and H2 blockers can temporarily reduce the amount of acid in the stomach, but in different ways. PPIs target the final stage of acid secretion in parietal cells. (10)

Proton pumps are embedded parts of cell membranes that move specific ions in or out of cells and their inhibition can prevent the secretion of stomach acid. (11)

PPIs, however, have also been linked to myriad adverse events.

NDMA Contamination Leads to Recall

Several lots of Zantac have been recalled recently due to the confirmed or potential presence of N-nitrosodimethylamine (NDMA), an organic compound that has been identified as a probable human carcinogen (cancer-causing). (12)

In June of 2019, an online pharmacy, Valisure, notified the U.S. Food and Drug Administration (FDA) they had discovered high levels of NDMA in some tested batches of ranitidine. (13)

Valisure’s screening revealed over 2 million nanograms of NDMA per tablet in tested batches. (14) After adjusting their tests to more closely resemble conditions inside the human stomach, levels of NDMA dropped to 300,000 nanograms per tablet, but the FDA’s acceptable daily intake limit for NDMA is 96 nanograms. (15)

Valisure’s discovery and Citizen Petition filed with the FDA prompted the FDA to conduct its own tests of different lots of ranitidine by many different manufacturers. The FDA used a different protocol and found much lower, though often still unacceptable levels of NDMA. (16) (17) (18)

For a free consultation and more information about your legal options, please contact us today.

Get a Free Case Review

In late September 2019, the FDA announced a voluntary recall of 14 lots of prescription ranitidine manufactured by Sandoz due to the presence of NDMA. (19) Two days later, the FDA announced a voluntary recall of Apotex Corp.’s over-the-counter generic and brand-name formulations of ranitidine labeled as Rite Aid, Walmart, or Walgreens brands. (20) More recalls were announced in October and November from multiple manufacturers and distributors. (21)

On December 4, 2019, the FDA asked manufacturers to test every lot of ranitidine before selling the drug to consumers. Lots that test above the acceptable daily intake level are not to be sold, and manufacturers must inform the FDA. (22)

What Is N-nitrosodimethylamine (NDMA)?

NDMA is classified as a probable human carcinogen by the U.S. Environmental Protection Agency (EPA) and the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC). (23) (24) NDMA is a byproduct of both natural and industrial processes. (25) It was once used in the production of rocket fuel. (26) (27)

People may be exposed to NDMA by: (28)

  • Food and beverages (such as cheese, bacon, cured meats, soybean oil, hotdogs, and beer, among others) that contain small quantities of NDMA.
  • Tobacco smoke.
  • Contaminants from rubber production and other industrial processes.
  • Pesticides and herbicides.
  • Contaminated drinking water.

NDMA may form inside the human body when certain substances react with nitrites in the body. The FDA has advised consumers taking ranitidine to consider limiting their consumption of foods high in nitrites due to “some evidence that there may be a link between the presence of nitrites and the formation of NDMA in the body if ranitidine … is also present.” (29)

What Products Are Affected?

So far, these ranitidine products have been voluntarily recalled nationwide: (30) (31) (32)

  • All over-the-counter Sanofi Zantac products, including Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®.
  • 75 mg and 150 mg ranitidine over-the-counter tablets manufactured by Apotex Corp and labeled by Walgreens, Walmart, and Rite-Aid.
  • Over-the-counter tablets and capsules manufactured by Dr. Reddy’s Laboratories Ltd; may be labeled by retailers such as CVS, Kroger, Target, Walgreens, and Walmart.
  • Tablets of over-the-counter ranitidine manufactured by Perrigo Company.
  • Capsules (all quantities and lots) manufactured by Novitium Pharma LLC.
  • All lots of ranitidine oral solution (15 mg/ml) manufactured by Lannett Company, Inc.
  • One lot of over-the-counter tablets (150 mg), 37 lots of prescription capsules (150 mg and 300 mg) and syrup (15 mg/ml) manufactured by Aurobindo Pharma USA.
  • 150 mg and 300 mg tablets, and syrup (15mg/ml), manufactured by Amneal Pharmaceuticals LLC.
  • Eight lots of syrup (150 mg/10 mL) packaged by American Health Packaging and manufactured by Lannett Company.
  • 150 mg and 300 mg capsules packaged by Golden State Medical Supply and manufactured by Novitium.
  • 150 mg/10 ml oral solution, packaged by Precision Dose Inc. and manufactured by Amneal Pharmaceuticals LLC.
  • 14 lots of prescription capsules distributed by Sandoz Inc.
  • All lots of 150 mg and 300 mg tablets manufactured by Glenmark Pharmaceuticals, Inc.

One manufacturer, Valisure, believes the ranitidine molecule’s “inherent instability” (33) causes it to breakdown inside the human stomach to form NDMA. (34) They claim that “all manufacturers, brand or generic, and all lots of ranitidine-containing medications are affected.” (35)

A 2016 study by Stanford University and Syracuse University researchers found levels of NDMA in urine increased 400-fold after healthy test subjects consumed one 150 mg tablet of Zantac. (36)

Possible Side Effects of Long-Term Use

Animal testing has shown NDMA induces development of tumors in the liver, kidney, and other organs in a variety of species exposed to NDMA. (37) Some studies link diets high in sources of NDMA (like cured meats) with cancers of the digestive tract. (38)

  1. Alltucker, K. (2019, November 7). Zantac is prescribed 15 million times a year. So how did it become a potential cancer risk? USA Today. Retrieved from https://www.usatoday.com/story/news/health/2019/11/07/how-did-zantac-become-potential-cancer-risk-fda-wants-find-out/2509043001/
  2. Kolata, Gina. (1988, November 28). Companies Search for Next $1 Billion Drug. Retrieved from https://www.nytimes.com/1988/11/28/business/companies-search-for-next-1-billion-drug.html
  3. Zantac 150 mg Maximum Strength. (2011). Retrieved from https://www.drugs.com/otc/123001/carton10007042-005.jpg
  4. GlaxoSmithKline. (2009, April). Zantac Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf
  5. Mayo Clinic. (2019, October 23). Gastroesophageal reflux disease (GERD). Retrieved from https://www.mayoclinic.org/diseases-conditions/gerd/symptoms-causes/syc-20361940
  6. Bowen, R. (n.d.). VIVO Pathophysiology. Histamine. Retrieved from http://www.vivo.colostate.edu/hbooks/pathphys/endocrine/otherendo/histamine.html
  7. Bowen, R. (n.d.). VIVO Pathophysiology. The Parietal Cell: Mechanism of Acid Secretion. Retrieved from http://www.vivo.colostate.edu/hbooks/pathphys/digestion/stomach/parietal.html
  8. Bowen, R. (n.d.). VIVO Pathophysiology. Histamine. Retrieved from http://www.vivo.colostate.edu/hbooks/pathphys/endocrine/otherendo/histamine.html
  9. National Institute of Diabetes and Digestive and Kidney Diseases. (2018, January 25). LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. H2 Receptor Blockers. Retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK547929/
  10. AstraZeneca Pharmaceuticals LP. (2018, June). NEXIUM Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf
  11. Bowen, R. (n.d.). VIVO Pathophysiology. The Parietal Cell: Mechanism of Acid Secretion. Retrieved from http://www.vivo.colostate.edu/hbooks/pathphys/digestion/stomach/parietal.html
  12. U.S. Food & Drug Administration. (2019, November 22). FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  13. Johnson, C. (2019, November 8). A tiny pharmacy is identifying big problems with common drugs, including Zantac. The Washington Post. Retrieved from https://www.washingtonpost.com/science/a-tiny-pharmacy-is-identifying-big-problems-with-common-drugs-including-zantac/2019/11/08/6dd009ca-eb76-11e9-9c6d-436a0df4f31d_story.html
  14. Koenig, D. (2019, September 26). Heartburn Drugs and Cancer: What Are the Risks? WebMD. Retrieved from https://www.webmd.com/heartburn-gerd/news/20190926/heartburn-drugs-and-cancer-what-are-the-risks
  15. Ibid.
  16. U.S. Food & Drug Administration. Woodcock, J. (2019, November 1). Statement on new testing results, including low levels of impurities in ranitidine drugs. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-new-testing-results-including-low-levels-impurities-ranitidine-drugs
  17. Light, D. and Kucera, K. (2019, September 9).Valisure. Citizen Petition. Retrieved from https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf
  18. U.S. Food & Drug Administration. (2019, November 1). Laboratory Tests | Ranitidine. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-ranitidine
  19. U.S. Food & Drug Administration. (2019, September 24). FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz-ranitidine-capsules-following-detection-impurity
  20. U.S. Food & Drug Administration. (2019, September 25). Company Announcement: Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity, N-nitrosodimethylamine (NDMA) Impurity in the product. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and
  21. U.S. Food & Drug Administration. (2019, November 22). FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  22. U.S. Food & Drug Administration. (2019, December 4). UPDATE – FDA requires additional testing of ranitidine and nizatidine as part of agency’s ongoing effort to help ensure product safety for patients and consumers. FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  23. United States Environmental Protection Agency. (2017, November). Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA). Retrieved from https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf
  24. World Health Organization. (2008). Guidelines for Drinking-Water Quality, 3rd edition including 1st and 2nd addenda, 2008. N-Nitrosodimethylamine (NDMA). Retrieved from https://www.who.int/water_sanitation_health/dwq/chemicals/ndmasummary_2ndadd.pdf
  25. Ibid.
  26. United States Environmental Protection Agency. (2017, November). Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA). Retrieved from https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf
  27. National Toxicology Program, Department of Health and Human Services. (2016, November 3). N-Nitrosamines. Report on Carcinogens, Fourteenth Edition. Retrieved from https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitrosamines.pdf
  28. Ibid.
  29. U.S. Food & Drug Administration. (2019, December 4). UPDATE – FDA requires additional testing of ranitidine and nizatidine as part of agency’s ongoing effort to help ensure product safety for patients and consumers. FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  30. U.S. Food & Drug Administration. (2019, December 4). FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  31. Sanofi. (2019, October 23). Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sanofi-provides-update-precautionary-voluntary-recall-zantac-otc-us
  32. U.S. Food & Drug Administration. (2019, September 23). Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated
  33. Valisure. (n.d.).Valisure Detects NDMA in Ranitidine. Retrieved from https://www.valisure.com/blog/uncategorized/detection-of-ndma-in-raniditine
  34. Valisure. (n.d.). Ranitidine Investigation Summary. Retrieved from https://www.valisure.com/wp-content/uploads/SUMMARY-of-Ranitidine-investigation-v1.8.pdf
  35. Valisure. (n.d.).Valisure Detects NDMA in Ranitidine. Retrieved from https://www.valisure.com/blog/uncategorized/detection-of-ndma-in-raniditine
  36. Teng, Z. & Mitch, W. (2016, June). Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine, Carcinogenesis. Retrieved from https://academic.oup.com/carcin/article/37/6/625/1744630
  37. National Toxicology Program, Department of Health and Human Services. (2016, November 3). N-Nitrosamines. Report on Carcinogens, Fourteenth Edition. Retrieved from https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitrosamines.pdf
  38. Ibid.

Get the Help You Need Today

Free Case Review