Zantac and ChemotherapyBaum Hedlund2020-04-01T16:56:08-07:00
Zantac and Chemotherapy
IMPORTANT UPDATE FROM THE FDA ON ZANTAC: On April 1, 2020, the FDA announced that drug makers are to immediately withdraw all Zantac and generic Zantac OTC medications from the market. The FDA determined that N-Nitrosodimethylamine (NDMA) in some ranitidine drugs “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…” NDMA is classified as a known carcinogen by the Environmental Protection Agency (EPA), the World Health Organization (WHO), and the FDA.
The recent announcement by the U.S. Food and Drug Administration (FDA) that the antacid drug Zantac (generic name: ranitidine) contains unsafe levels of N-Nitrosodimethylamine (NDMA)—a highly carcinogenic chemical— is particularly problematic for one group of individuals who need the drug to control their acid reflux, heartburn, and gastrointestinal reflux disease (GERD).
Zantac is widely prescribed to control the symptoms of GERD in patients who are receiving chemotherapy for cancer. Chemotherapy drugs are very hard on the gastrointestinal tract—the organ system that includes the mouth, esophagus, stomach, and intestines. This is due to a unique characteristic of the cells that form the lining of the tract, the epithelium. They are among the fastest-growing cells in the body. The intestinal lining, for example, regenerates itself every five to seven days.
Unfortunately, fast growth is also a characteristic that distinguishes most cancer cells from normal cells, which is why many chemotherapy drugs have been designed to target the cellular growth mechanisms of fast-growing cells. As a consequence, the rapidly dividing cells of the stomach and intestinal tract are also targeted, and they are quite sensitive to the effects of chemotherapy drugs. (Hair follicles are also rapidly dividing, which explains the hair loss commonly seen in many cancer patients undergoing chemo.)
The bad news for those who use Zantac for chemo side effects is that this is not the case of an accidental or unintentional contamination of an otherwise safe drug. The first report of the Zantac-NDMA connection came from the online pharmacy Valisure. Valisure is registered with both the U.S. Drug Enforcement Agency and the FDA, and its testing laboratory is ISO (International Standards Organization) 17025 accredited—the same accreditation achieved by the medical products laboratories that do drug testing for the FDA.
Adding to the concern is Valisure’s explanation of these results. The problem, they believe, is a design defect in the drug itself. In a citizen’s petition to the FDA requesting the removal of all ranitidine products from the market, Valisure explained that ranitidine contained within its molecular structure both of the chemical elements need to make N-Nitrosodimethylamine: a nitrite group (N) and dimethylamine (DMA). Valisure proposed to the FDA that ranitidine, when ingested, breaks down into these two elements. The DMA is then free to recombine with the nitrite group from ranitidine or nitrites already in the stomach to form NDMA. Scientists believe a similar mechanism, involving the breakdown of ranitidine during chlorination of wastewater, explains the presence of NDMA in drinking water.
“N-Nitrosodimethylamine (NDMA) is a member of a family of extremely potent carcinogens, the N-nitrosamines.”
William A. Mitch, et al., “N-Nitrosodimethylamine (NDMA) as a Drinking Water Contaminant: A Review,” Environmental Engineering Science, 20 (5), 2003.
Chemotherapy is known to cause heartburn and GERD, the primary conditions for which Zantac is prescribed.
Chemotherapy and radiation may cause damage to the salivary glands and difficulty swallowing. Difficulty swallowing is a common symptom experienced by those suffering from GERD, and this makes it difficult to clear stomach acids that back up into the esophagus as a result of GERD.
FDA Reports “Unacceptable Levels” of NDMA in Zantac
On October 2, 2019, the FDA reported the results of initial Zantac testing, but curiously buried the most important finding in the next-to-last sentence of the update: “To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine.” The agency has not said how unacceptable the levels are, nor has it raised the Zantac chemo question.
Valisure’s evidence, which was sent to the FDA before the agency issued its first press release on Zantac, strongly suggests that the issue is not an “impurity” in ranitidine, but a defect inherent in the drug.
Baum Hedlund Aristei & Goldman Zantac Attorneys Believe FDA is Failing to Protect the Public from Cancer Risk
The Zantac attorneys at the law firm of Baum Hedlund Aristei & Goldman believe the FDA’s statements on ranitidine hcl fall well short of addressing a serious threat to public health. Further, we believe the FDA is confusing consumers by saying the presence of NDMA in Zantac is an “impurity.” This cancer-causing chemical is not an impurity, but a design defect that the makers of Zantac knew or should have known about before, during, and after the drug came to market.
Numerous regulators outside the U.S. have cautioned patients against taking Zantac, noting the availability of safer alternatives. The FDA, on the other hand, continues to confuse the American public by telling consumers that they do not need to stop taking Zantac or Zantac OTC generics.