Zantac (Ranitidine) 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 products including CVS and Rite Aid Acid Reducer, Walgreens’ Wal-Zan, store brands labeled Acid Controller, Acid Reducer or Heartburn Control and other 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:
- Breast cancer
- Testicular cancer
- Bladder cancer
- Kidney cancer
- Prostate cancer
Some of these people or their loved ones may be considering filing Zantac (ranitidine) cancer lawsuits.
NDMA Zantac (Ranitidine) 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 (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 (Ranitidine)
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 and store brands or generics, 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 manufacturers of prescription medications containing ranitidine include Novartis-AG’s Sandoz, Apotex, GlaxoSmithKline and others have also recalled their products, along with retailers whose store brands include CVS and Rite Aid Acid Reducer, Walgreens’ Wal-Zan, other store brand labels including Acid Control, Acid Reducer, Heartburn Relief and generic formulations of Ranitidine have also recalled their medications and removed them from store shelves.
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 or generic ranitidine products off of store shelves. Similar actions have been taken at other stores around the U.S. and the FDA has stated that ranitidine has been permanently discontinued from the U.S. market.
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 has advised that patient should consult with their health care provider before making any changes to their regimen.
Zantac (Ranitidine) Legal Information
People who have developed stomach, gastric, bladder, kidney, pancreatic, or colon cancer may be considering filing Zantac (ranitidine) 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 formulations or certain store brands or generic formulations of ranitidine 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)