Zantac Cancer Investigation
In September of 2019, the U.S. Food and Drug Administration (FDA), along with European and other health authorities warned that heartburn and reflux medications containing ranitidine, including popular brand-name drug Zantac, may contain a carcinogen known as NDMA.
Zantac’s manufacturer, Sanofi-Aventis has recalled its Zantac products and some pharmacies or drugstores including national retailers like CVS, Walmart and Walgreens may be pulling both name-brand Zantac and store-brand ranitidine products from their shelves due to concerns about NDMA levels in medication and increased cancer risk.
People who took Zantac or products containing ranitidine for at least 60 days, may have been exposed to increased risk of cancer such as:
- bladder cancer
- gastric cancer
- stomach cancer
- kidney cancer
- pancreatic cancer
- colon cancer
Some of these people or their loved ones may be considering filing Zantac cancer lawsuits.
NDMA Zantac Contamination
NDMA is known chemically as N-nitrosodimethylamine. NDMA is a semi-volatile compound used in or a byproduct of industrial applications such as petroleum and pesticide manufacturing.
It is used as a stabilizer in gasoline and other fuels along with other products such as industrial lubricants but is considered an environmental contaminant that is sometimes found in water and foods. NDMA is a known carcinogen, and strictly regulated by the U.S. Environmental Protection Agency (EPA).
Zantac and Ranitidine NDMA Contamination Effects
The FDA has warned that Zantac and generic products containing heartburn medication, ranitidine, may contain NDMA at levels that are 3,000 to 26,000 higher than legally allowed.
While short-term exposure to NDMA may carry a low risk of cancer development, experts have stated that longer term risk of exposure in medication is not known. NDMA however has been shown to be carcinogenic in industrial settings.
NDMA carcinogen exposure may be related to:
- Gastric cancer
- Stomach cancer
- Bladder cancer
- Kidney cancer
- Intestinal cancer
- Colon cancer
- Pancreatic cancer
- Other types of cancer
Other Drugs Contaminated with NDMA Unrelated to Zantac
During 2018 and 2019, a number of medications containing the Angiotensin II Receptor Blocker (ARB) medication, Diovan or generic formulations of valsartan, were recalled for contamination with NDMA and similar chemicals. All of the contaminated lots of medication thus far appear to have been made with valsartan active pharmaceutical ingredient (API) that was manufactured at chemical plants in India or China.
Though the valsartan contamination events continue to expand, and more valsartan medications require recall, this type of contamination does not appear to be related to the cause of problems with Zantac and ranitidine-containing products. Experts now believe that ranitidine, the active ingredient in Zantac, may be unstable and under certain conditions, causing the formation of NDMA as something like a chemical byproduct. There is some evidence that concern about similar issues may have been raised as early as the mid-1980s.
Ranitidine Product Recalls
Brand-name Zantac is manufactured by Sanofi-Aventis, who has issued a voluntary recall of its products. Generic formulations of heartburn medications containing ranitidine include Novartis-AG’s Sandoz, Apotex, GlaxoSmithKline and others have also recalled their products. Countries affected by Zantac and generic ranitidine recalls now include the U.S., Hong Kong, India, Pakistan, Taiwan, Canada and countries of the European Union. The FDA has also requested that manufacturers act quickly to voluntarily remove any additional medications that may show the same degradation problems such as Axid or products containing a similar antacid, nizatidine.
In addition to manufacturer recalls, a number of large retailers including drugstore chains CVS and Walgreens and big-box store Walmart, have pulled Zantac and store-brand generic ranitidine products off of store shelves. Similar actions may be taken at other stores around the U.S.
Health experts have noted that there are a number of alternative medications available to treat heartburn in both prescription and over-the-counter formulations. The FDA’s warning, however, does not recommend that people discontinue taking ranitidine but advise that patient should consult with their health care provider before making any changes to their regimen.
Zantac Cancer Lawsuits
People who have developed stomach, gastric, bladder, kidney, pancreatic, or colon cancer may be considering filing Zantac cancer lawsuits. Past medical injury lawsuits have provided compensation for medical costs, lost wages, pain and suffering or wrongful death if a death has occurred.
People or loved ones of those who may have developed cancer after taking Zantac prescription or over-the-counter heartburn medications regularly for at least 60 days should seek advice from legal experts.
- Popular heartburn drug ranitidine recalled: What you need to know and do, Harvard Health Publishing (09/2019)
- CVS pulls Zantac and similar heartburn drugs because of cancer worries, CNN Health (09/2019)
- Statement alerting patients and health care professionals of NDMA found in samples of ranitidine, U.S. Food and Drug Administration (09/2019)
- Zantac is prescribed 15 million times a year. So how did it become a potential cancer risk?, USA Today (11/2019)