Zantac was voluntarily pulled from shelves as a “precautionary measure” after it was determined that more safety assessments are needed after 1,500 samples tested positive for a carcinogen impurity. Ranitidine (Zantac) is an H2 blocker used to treat heartburn. It has been on the market since 1981. Doctors write 15 million prescriptions of Zantac a year, on top of the $142 million in annual OTC sales. Many patients want to know: How did such a popular, widespread drug become a cancer risk? And more importantly, should they stop using it?
History of the Zantac Recall
- September 2019: The U.S. Food and Drug Administration (FDA) announced low levels of a “probable human carcinogen” called Nitrosodimethylamine (NDMA) in some Zantac products.
- October 2019: Drug manufacturer Sanofi voluntarily recalled all over-the-counter Zantac products in the U.S. as “a precautionary measure.” By the end of the month, three other pharmaceutical companies were voluntarily pulling similar Ranitidine-based heartburn medications from the shelves.
- November 2019: According to the FDA, the levels of impurity in the drugs were “similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
What Does Research Say About NDMA?
Ranitidine, the active ingredient in Zantac, works to reduce heartburn symptoms by binding to proteins in the stomach to reduce the amount of gastric acid that is produced, and consequently decrease backflow into the esophagus and eliminate other symptoms of reflux.
NDMA is a contaminant that arises due to industrial or chemical processes, according to the Environmental Protection Agency (EPA). In addition to appearing in Zantac, it has also been found in smoked or cured meats, fish, cigarette smoke, and shampoos.
The cancer link is inconclusive at this point, though the spotlight is shining brightly now. A 2015 meta-analysis of 49 studies published in the journal Nutrients discovered a link between high dietary consumption of NDMA and an increased risk of gastric cancer. Those with the highest intake had a 34 percent greater risk of stomach cancer than those with the lowest intake.
Another large study, published in the journal Carcinogenesis in 2019, linked pancreatic cancer with high NDMA intake from fermented cheese, pizza, grains, seafood, and beer. People who ate larger portions of these foods were 93 percent more likely to develop cancer.
So, what if you were ingesting NDMA not only through normal foods in your diet but through regular, long-term use of a drug like Zantac?
Valisure – the company that first discovered the heightened NDMA levels – claims the problem has been there since at least 1987. Zantac’s originator, Glaxo Research Group, reported that “numerous studies raised concerns” about Ranitidine. Their internal studies found no significant NDMA increase within 24 hours of taking the drug, but researchers used less accurate testing methods and discarded samples containing Ranitidine prematurely. Stanford scientists and Valisure researchers found different results that could represent “a huge public health problem.” When testing Zantac in stomach-like fluids, Valisure identified NDMA levels over 3,100x the FDA’s daily threshold.
“Our chemists believe that it is formed by the molecule ranitidine reacting with something, either during the manufacturing synthesis or during the finished dosage form or during storage,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told the House Committee on Energy and Commerce on Oct. 30th. The FDA did not find that Zantac mingled with stomach fluids to form carcinogens, she added, but Stanford research has suggested that this may be the case and that more testing needs to be done.
What Should You Do?
The “acceptable limits” of NDMA are 96 nanograms per day. Manufacturers will be asked to voluntarily recall any products that exhibit levels above this limit. Researchers at Memorial Sloan Kettering Cancer Center in New York are conducting cancer studies associated with Zantac and its generic variants.
In the meantime, patients taking prescription medication should always consult with their doctors, rather than abruptly discontinue a drug. People using Zantac more than twice a week may find better relief with proton pump inhibitors, which do not lose efficacy with regular use the same way H2 blockers do. Consumers should talk to their doctors about other alternatives like Pepcid, Tagamet, Nexium, Prevacid, or Prilosec – which have been all tested and confirmed to contain no NDMA.
Anyone experiencing sudden weight loss, bloody or tarry stools, fatigue and weakness, or new abdominal pain should see a doctor at once. Patients who smoke or have a family history of cancer are at greater risk and may want to consider switching to a different type of medication.
Zantac Recall Information
If you have become sick after using Zantac and have questions about the Zantac recall and your legal right to compensation, contact Showard Law Firm for a free consultation. We charge no upfront fees, and you owe us no money unless we recover damages on your behalf.
