What is Zantac?
Zantac, generic ranitidine, is a medication that treats stomach acid levels in conditions such as peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome (excess acid caused by tumors). Research published in 2012 also indicates that it may be effective in treating hives (urticaria).
Zantac may be taken orally or injected either into muscle tissue or a vein. Zantac is part of a class of antacids known as histamine (H2) blockers, which prevents the action of the naturally-occuring compound involved in localized immune response (such as sneezing, itching, and watery eyes) as well as the regulation of the digestive process.
According to ClinCalc.com, there are approximately 15 million prescriptions for ranitidine written annually, making it the 50th most commonly-prescribed drug in the United States.
What is NDMA?
N-nitrosodimethylamine (NDMA) is a probable carcinogen. It is an industrial waste product, yellowish in appearance with a faint, distinctive odor. Found in cured meats and tobacco smoke, it is a common environmental contaminant. This substance has also been used as a stabilizer in industrial lubricants as well as an ingredient in rocket and jet fuel.
In 2018, NDMA contamination was discovered in a number of blood pressure medications known as ARB blockers, such as Valsartan. The source of the contamination was eventually traced back to a factory in China, where changes in the manufacturing process led to a chemical reaction, resulting in the formation of NDMA.
It is not yet known how NDMA came to contaminate Zantac.
Drugmaker Novartis announced on Sept. 19 that it was stopping the distribution of generic Zantac. However, it is not being pulled from drugstores, WebMD reported.
Does Zantac Cause Cancer?
The FDA has not called upon patients to stop taking Zantac if they have been prescribed the medication by a doctor. Nonetheless, the FDA is advising patients who take Zantac regularly to speak with their health care providers about alternative treatments.
The federal agency also recommends that those who are taking the over-the-counter version to consider using other drugs that have been approved for their conditions or make lifestyle changes that may relieve the symptoms of GERD and other gastrointestinal conditions.
In addition to the FDA, drug agencies in other countries around the world have also begun recalling the popular heartburn drug.
NDMA behaves like a cancer-causing chemical “because it modifies your DNA,” Stanford University professor Dr. William Mitch told ABC News.
Mitch is part of a research team at Stanford that has shown that there is a link between people who take Zantac and high levels of NDMA. The current theory is that there are enzymes in humans that create NDMA as a reaction to Zantac.
The Italian Drug Agency announced on Sept. 20 that all versions of Zantac that contained the active ingredient that was made at Saraca Laboratories Ltd. in India were being recalled. The Italian government also banned other Zantac products while it conducts tests to see if other versions are also contaminated.
Have Zantac Cancer Lawsuits Been Filed?
The first Zantac lawsuit filed drugmaker Sanofi was filed in California on the same day the FDA published its safety warning. A second lawsuit has been filed in Florida by a man who contracted breast cancer, a very rare form of the disease in men, after taking Zantac over a nine-year period.
The plaintiffs say that the drugmaker had an obligation to know about the potential for contamination and to advise the medical community of the danger.
There has been a large body of research published over the past decade, in which researchers have found that when ranitidine comes into contact with water, it can set off a chemical reaction that can result in the formation of NDMA. Although this research has been widely available, the defendants did not issue any warnings to consumers or their doctors, the lawsuits allege.
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