The once presumed innocent antacid, Zantac, has recently been reported to contain high levels of NDMA, a well-known human carcinogen. Studies are bringing to light that the OTC and prescription drug commonly known as Zantac, or ranitidine, is harboring high doses of this carcinogen and is the probable cause of numerous cases of cancer in users today.
Hitting the market in 1983, ranitidine, branded by the trade name Zantac, was touted as a safe, effective medication used to reduce the production of stomach acid. Zantac is commonly used to treat and prevent ulcers, heartburn, sour stomach, acid indigestion and gastroesophageal reflux disease (GERD). Zantac was the first member of a new class of medications, known as histamine H2-receptor antagonists (H2 blockers) and while it’s also available over the counter, it currently ranks as the 50th most prescribed medication in the United States.
On September 13th, 2019, the U.S. Food and Drug Administration (FDA) released a warning, identifying high levels of contaminant of the drug N-nitrosodimethylamine (NDMA) found in Zantac and ranitidine products alike. NDMA has been identified by numerous health organizations as a known carcinogen with exposure to the drug causing a wide range of complications from cancer to liver and kidney damage. While the FDA acceptable limit of daily NDMA intake is set at below 100 nanograms, the warning identified the presence NDMA in Zantac at levels ranging from 3,000 to 26,000 times higher than FDA approved standards.
N-nitrosodimethylamine (NDMA) is no longer manufactured in the United States, leading to a frantic search for the explanation of how it’s being found in a common antacid. The FDA currently speculates that the NDMA in Zantac is the result of a chemical impurity. FDA research on both name brand Zantac and generic ranitidine confirm varying levels of NDMA in products.
Others allege that all users are at risk of exposure as NDMA is formed after consumption. The active ingredient in Zantac has an inherent molecular structure that may react with itself, producing dangerous levels NDMA when exposed to high temperatures inside the body.
In January of 2020, Emery Pharma released test results showing NDMA levels in Zantac increase due to exposure to high heat during routine shipping and storage. Researchers with the pharmacy found that stored Zantac medication exposed to high heat can produce unacceptably high levels of NDMA in as few as five days.
A Citizen’s Petition was filed with the FDA by the independent pharmacy Valisure after similar results were found. The petition cites there is a “compelling case for ranitidine being a likely human carcinogen.” Valisure has also sent a copy of the recall petition to the World Health Organization (WHO) and International Agency for Research on Cancer (IARC), suggesting ranitidine in Zantac is a human carcinogen. Valisure suggests in their petition that Zantac should be recalled by the FDA and all sales should cease.
The FDA has issued a news release as of 04/01/2020 announcing that it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. Learn more about the FDA’s News Release Here.
Recalls have been issued following the FDA detecting cancer causing NDMA in several brand name and generic heartburn medications. For a list of recalled medications and statements from the FDA, please CLICK HERE.
Shortly after the introduction of Zantac, studies began to emerge, suggesting that Zantac has a strong potential to form NDMA under certain conditions.
The medical journal Carinogensis published a study in March 2016 conducted by researchers showing high concentrations of NDMA in the urine of 10 healthy individuals on Zantac. Volunteers underwent urine tests before and after taking a 150mg dose of Zantac. The results showed a staggering 400x increase in NDMA in urine tests after Zantac was consumed. Even more alarming was that researchers speculated that metabolism of NDMA within the body likely resulted in low estimates of the drug in urine tests. The findings highlighted the need for additional studies to better evaluate the cancer risk, particularly bladder cancer from Zantac based on the NDMA excretion rates.
Individuals who have regularly used Zantac over an extended length of time may be vulnerable to developing the following types of cancer:
If you or a loved one have had taken Zantac regularly and developed one of the above referenced cancers, we urge you to contact our office for a FREE consultation. Our attorneys are currently reviewing cases involving cancers developed in individuals who used Zantac, and welcome the opportunity to review your case, and educate you of your options.
To review your claim with an attorney, please contact our office directly at (239) 466-1161. Additionally, you may also fill out the form below and a member of our staff will contact you once your inquiry is received.