Concerns about the safety of Zantac, a popular prescription and over-the-counter medication used to treat heartburn and ulcers caused by stomach acid, are on the rise following a recent U.S. Food and Drug Administration (FDA) warning and subsequent recalls. According to the FDA, the agency is investigating a potential link between Zantac and cancer after finding a carcinogenic chemical known as N-Nitrosodimethylamine (NDMA) in Zantac tablets at levels that are 3,000 times higher than the FDA’s daily intake limit. And while some believe that the alleged Zantac cancer risk is associated with an NDMA contamination in Zantac tablets, there is growing evidence that Zantac is itself a carcinogen.
Zantac is the brand name of the medication ranitidine, an H2 (histamine-2) blocker designed to decrease the amount of acid produced by the stomach. OTC ranitidine is approved as a treatment to prevent and relieve heartburn associated with acid indigestion and sour stomach, while prescription ranitidine is approved for multiple indications, including the treatment and prevention of ulcers in the stomach and intestines and the treatment of gastroesophageal reflux disease (GERD). The first report of a potential link between Zantac and cancer came in June 2019, when Valisure, an online pharmacy company that operates an International Standards Organization (ISO) 17025 accredited laboratory, reported the presence of NDMA in Zantac and petitioned the FDA to remove the heartburn drug from the market.
At the center of the Zantac safety debate is NDMA, a water-soluble chemical that was once used to make rocket fuel. Today, NDMA is made only for research purposes, but it can also occur through chemical reactions and as a byproduct of industrial processes. As a result, humans can be exposed to low levels of NDMA from products like shampoos, cleansers, pesticides, tobacco and certain foods. However, the amount of NDMA found in Zantac and other recalled medications far exceeds the acceptable levels established by the FDA. Since last year, the FDA has been investigating NDMA and other carcinogenic impurities in angiotensin II receptor blocker (ARB) medications and ended up issuing numerous recalls as it uncovered potentially dangerous levels of NDMA and other chemicals in a number of blood pressure medications and heart failure drugs. Over the past year, dozens of generic blood pressure medications, including valsartan, losartan and irbesartan, have been recalled by the FDA due to contamination by NDMA and two other chemicals, N-Nitrosodiethylamine (NDEA) and N-Methyl 4-amino butyric acid (NMBA), which are believed to cause cancer in humans.
The FDA has set the acceptable daily intake limit of NDMA at 96 ng (nanograms) per tablet. Valisure, in its initial batch testing of Zantac, found levels of NDMA as high as 3,267,968 ng per tablet, more than 34,000 times the limit set by the FDA. Amid concerns that the increased heat of the testing process may have contributed to the results, Valisure tested the medication under conditions similar to those found in the stomach. According to the results, the NDMA levels in Zantac ranged from 23,600 ng to 304,500 ng per tablet, still more than 3,000 times the limit the FDA considers “safe.”
Zantac contains within its chemical structure the two ingredients necessary to make NDMA – the “N” (nitrite) and the “DMA” (dimethylamine) and when Zantac’s active ingredient breaks down, it may produce potentially dangerous levels of NDMA. Zantac testing suggests that once the medication is ingested, the nitrite and DMA may separate from the Zantac molecule and attach to nitrites in the stomach to form NDMA, which means Zantac’s very chemical makeup could be what makes the drug potentially unsafe. According to a Valisure Citizen Petition on Ranitidine sent to the FDA on September 2019, “Valisure’s testing reveals NDMA levels so high that the nitroso for NDMA likely comes from no other source than the ranitidine molecule itself.”
Although this information about NDMA contamination in Zantac tablets is relatively new, research linking Zantac treatment to a potential risk of cancer actually dates back several years. In 2016, scientists at Stanford University published a study in which urine samples from adults taking 150 mg doses of ranitidine were tested 24 hours before and after taking the medication. According to the study findings, levels of NDMA in the urine increased 400-fold. Even more alarming, the researchers noted that these levels significantly underestimate the actual levels of NDMA occurring in patients taking Zantac, since only a small fraction of NDMA is excreted in the urine.
Since the potential for ranitidine to cause cancer in users first became public, the FDA has announced several Zantac and ranitidine recalls, citing “unacceptable levels of NDMA” in the drug products. During the 20 years Zantac has been on the market, the drug has been used by millions of consumers to relieve heartburn and acid indigestion, but these recalls and study findings have raised serious concerns about the safety of the once-trusted medication. If you or a loved one took prescription or OTC Zantac and you have since been diagnosed with bladder cancer, liver cancer, esophageal cancer or another type of cancer, contact an experienced Zantac cancer attorney as soon as possible to find out whether you may be eligible for compensation.