Ranitidine (also known by its brand name, Zantac, which is sold by the drug company Sanofi) is available both over the counter (OTC) and by prescription. OTC ranitidine is commonly used to relieve and prevent heartburn, also treat and prevent ulcers of the stomach and intestines as well as gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, peptic ulcer disease, acid indigestion, and heartburn.
NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans.
FDA Recalls All Ranitidine (Zantac) Products,
Citing Increased Risk of Cancer
FDA Issues Recall
The FDA has requested all ranitidine (Zantac) products be pulled from the market immediately, according to a statement. The recall includes all prescription and over-the-counter ranitidine drugs as ongoing investigations uncovered levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, increase over time.
“The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity,” the FDA stated.
Increased risk of cancer after taking Ranitidine (Zantac)
NDMA, n-nitrosodimethylamine, is a potential hepatotoxic, and exposure has been linked to numerous complications and symptoms ranging from bladder cancer, stomach cancer, liver fibrosis and scarring, and tumors in the liver, kidneys, and lungs. Other symptoms of NDMA exposure include headaches, fever, nausea, jaundice, vomiting, abdominal cramps, enlarged liver, dizziness, and reduced function of the liver, kidneys, and lungs. The World Health Organization described NDMA as a chemical that is “clearly carcinogenic.”
The U.S. Food and Drug Administration is working alongside regulators and industry partners to discover the source of impurities in ranitidine. The FDA is examining ranitidine NDMA levels and evaluating the potential risk to patients. The investigation is ongoing, and the agency plans to take appropriate measures.
If you have used Zantac (Ranitidine) and have a serious illness, please let us know immediately. You may contact us by filling out the form or call (781) 350-0000.