Zantac was first introduced to the U.S. drug market in 1983. It was already being used to treat heartburn caused by gastroesophageal reflux disease (GERD) and ulcers in over 30 countries around the globe. By 1988, it was the world’s best-selling drug. Zantac also earned the recognition as being one of the first-ever drugs to top $1 billion in yearly sales.
But recently, the popular drug hit a downward spiral. In late 2019, the Food and Drug Administration (FDA) found evidence of a probable human carcinogen (i.e. cancer-causing agent) in ranitidine-containing medicines, including Zantac.
While the harmful contaminant has not yet been directly linked to cancer in humans, it has been shown to cause cancer and death in animals. Some people who developed bladder and stomach cancer after taking Zantac filed lawsuits against the drug’s manufacturers.
The Food and Drug Administration (FDA) issued a statement in September 2019, advising the public of a nitrosamine impurity called N-nitrosodimethylamine (NDMA) found in some ranitidine medicines, including Zantac.
Pharmaceutical company Valisure routinely tests all its medications. It first alerted the FDA on September 9, 2019, that it found “extremely high levels” of NDMA in ranitidine products.
This isn’t the first time that the FDA became aware of NDMA contamination in medicines containing ranitidine. The FDA began investigating NDMA in the blood pressure medication Valsartan in 2018. The drug was later recalled.
NDMA has since been found in other angiotensin II receptor blockers.
FDA issues its statement alerting patients and health care professionals to NDMA in some ranitidine medicines, including Zantac. FDA says investigation is ongoing. The federal agency did not ask individuals to stop taking ranitidine at thaa
FDA announces voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc. due to NDMA.
FDA alerts public to voluntary recall of over-the-counter (OTC) ranitidine tablets manufactured by Apotex Corp. and labeled by Walgreens, Walmart and Rite-Aid due to NDMA.
FDA provides update on testing of ranitidine medicines for NDMA impurities. FDA says it is assessing potential impact on patients taking ranitidine products. The federal agency also asks manufacturers of ranitidine to conduct their own testing for levels of NDMA in their medications and to send the results to FDA to be tested by its’ scientists, as well.
Zantac manufacturer Sanofi initiates a voluntary recall of all Zantac OTC medicines in the U.S. due to inconsistencies in preliminary test results of the active ingredient ranitidine in its’ products. The company says that the investigation is ongoing.
FDA releases a second method for manufacturers and regulators to test for NDMA in ranitidine products. The second method uses a “more widely available technology” than the first.
FDA alerts public to voluntary recalls of ranitidine by Perrigo Company plc, Novitium Pharma LLC and Lannett Company Inc.
FDA posts lab results that show NDMA levels in all ranitidine and nizatidine samples tested. Results also showed no additional NDMA was generated in the stomach. FDA says it will recommend recalls to manufacturers with NDMA levels above acceptable daily intake limit of 0.096 micrograms or 0.32 parts per million (PPM). Lastly, the federal agency determined that levels of ranitidine and nizatidine in samples tested were similar to levels found in common foods like grilled or smoked meats.
Director Janet Woodcock MD for the Center for Drug Evaluation and Research issues a statement the same day stating: “Although many of these levels of NDMA observed through FDA testing are much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines.
FDA alerts public to voluntary recalls of ranitidine by Aurobindo Pharma USA.
FDA alerts public to voluntary recalls of ranitidine by Amneal Pharmaceuticals LLC and American Health Packaging.
FDA alerts public to voluntary recalls of ranitidine by Golden State Medical Supply and Precision Dose Inc.
FDA announces that manufacturers of ranitidine and nizatidine products have been asked to expand their testing for NDMA to include all lots of medication before they are made available to consumers. Manufacturers must inform the federal agency of all testing that shows levels of NDMA above the acceptable daily intake limit. Investigations are ongoing to determine the reasons for NDMA in these drugs, including ways in which they behave in the human body. The FDA says there is some evidence of a link between the presence of nitrates (found in processed meats) and the formation of NDMA in the body if these drugs are also present.
FDA alerts public to voluntary recalls of ranitidine by Glenmark Pharmaceutical Inc.
FDA alerts public to voluntary recalls of ranitidine by Mylan.
FDA alerts public to voluntary recalls of ranitidine by Appco Pharma LLC and Northwind Pharmaceuticals.
FDA alerts public to additional voluntary recalls of ranitidine products by American Health Packaging and Amneal Pharmaceuticals LLC.
FDA testing found evidence of NDMA in certain ranitidine medicines, including Zantac. NDMA exposure can potentially affect the bladder, brain, liver, kidneys, lungs and stomach, per a report by the World Health Organization (WHO). WHO also classifies NDMA as a B2 carcinogen or “probable human carcinogen,” and the U.S. National Toxicology Program lists the known environmental contaminant as a compound that is “reasonably anticipated to be a human carcinogen.”
The acceptable daily intake of NDMA is 96 mg or 0.32 parts per million for ranitidine. Exceeding that amount can expose patients to serious health risks. WHO reported that exposure to high levels of NDMA is believed to cause stomach and colorectal cancers. It is also toxic to the liver, even in small amounts. Zantac lawsuits show that ranitidine can break down within the body to form NDMA at levels well in excess of the permissible daily intake. Plaintiffs allege they developed cancer as a result of exposure to the high levels of NDMA formed by Zantac.
Reported Valsartan Injuries & Side Effects:
If you have taken Zantac in the past and you have experienced one or more of these effects, you should speak with your doctor right away. You may also qualify to participate in a Zantac Injury Lawsuit if you have experienced any of these adverse health effects.
Receiving a cancer diagnosis is troubling enough on its own. Deciding whether to file a lawsuit should not add to your stress. Our attorneys are knowledgeable about legal claims involving drug injuries. Let us help answer your questions and get you on the road to recovery. Now is time best spent with your family.