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A National Personal Injury Law Firm > Heartburn Medication, Zantac Contaminated with Cancer-Causing Substance

Heartburn Medication, Zantac Contaminated with Cancer-Causing Substance

Zantac Litigation Attorneys | Information on Zantac and Contamination

Zantac, also known as Ranitidine, is an over-the-counter (OTC) and prescription drug used to prevent and relieve heartburn. After an analytical pharmacy known as Valisure ran routine testing on Zantac and its generics, they alerted the FDA of its initial findings in June of 2019. Their research along with that of Stanford University, found that N-nitrosodimethylamine (NDMA) was the result of the “inherent instability” of the ranitidine molecule. On September 13th, Valisure petitioned the U.S. Food and Drug Administration (FDA) to recall all products containing ranitidine; on the same day, the FDA announced the link between Zantac to the carcinogen NDMA, but the press announcement stated Zantac contained “low levels” of NDMA. However, at that time, the FDA did not issue any recall like Valisure recommended, or even for patients to stop taking the medication. On October 2nd, the FDA released an update which stated that, “to date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine.” On October 23rd, the FDA released an additional update where they alerted health care professionals and patients to two voluntary recalls of ranitidine. The first recall was by Dr. Reddy’s Laboratories Ltd who is voluntarily recalling all prescription and over-the-counter ranitidine tablets and capsules manufactured by the company; the OTC medicines may be labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger. The second was by Sanofi who is voluntarily recalling OTC ranitidine due to possible NDMA contamination.

What is NDMA?

N-nitrosodimethylamine (NDMA) is a semivolatile organic chemical that forms in both natural and industrial processes. NDMA was formerly used in the production of rocket fuel, antioxidants and softeners for copolymers; in the United States it is currently used only for research purposes. NDMA is a probable human carcinogen, meaning a substance that could cause cancer. Cancers that may be related to exposure to NDMA include bladder cancer, colon cancer, intestinal cancer, kidney cancer, pancreatic cancer, and stomach cancer. 

The concern is that medications, such as Zantac and its generics, that contain ranitidine, could generate very high levels of NDMA in the human body. Three years ago, William Mitch, a professor of Stanford University, and his colleague Teng Zeng, a professor of Syracuse University, published their research that suggested that Ranitidine could be converted into NDMA inside the body. They conducted a small study which included 10 volunteers who were given a tablet of Zantac; and then, the volunteers urine was tested. The testing found that NDMA levels were more than 400 times greater than what the FDA considers acceptable. The FDA changed protocol for  measuring NDMA, and even after adjusting for the new protocol the professors still got similar results.

 

As of February 2019, the FDA requires that the label of Uloric now has the agency’s strictest and most severe warning, a black box warning.

Symptoms of Overexposure to NDMA Include:

-Abdominal Cramps

-Dizziness

-Enlarged Liver

-Fever

-Headaches

-Jaundice

-Nausea

-Reduced function of the liver, kidneys and lungs.

The concern is that medications, such as Zantac and its generics, that contain ranitidine, could generate very high levels of NDMA in the human body. Three years ago, William Mitch, a professor of Stanford University, and his colleague Teng Zeng, a professor of Syracuse University, published their research that suggested that Ranitidine could be converted into NDMA inside the body. They conducted a small study which included 10 volunteers who were given a tablet of Zantac; and then, the volunteers urine was tested. The testing found that NDMA levels were more than 400 times greater than what the FDA considers acceptable. The FDA changed protocol for  measuring NDMA, and even after adjusting for the new protocol the professors still got similar results.

Entitled to Compensation

If you or a loved one has been diagnosed with cancer after having taken Zantac, please reach out to us immediately for a free case evaluation. Call 855-566-3752 or contact us online.

Put an experienced lawyer on your side, contact Greg Jones Law today.

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