All ranitidine products (Zantac) have been removed from the market in the United States due to the presence of N-nitrosodimethylamine (NDMA), a volatile yellow oil that was once used to make rocket fuel. This use was stopped after unacceptably high levels of NDMA were found in water and soil samples collected near rocket engine testing facilities. Today, NDMA is only produced in the U.S. for use in research as a cancer-causing chemical, but its unexpected presence in several popular pharmaceutical drugs has raised serious concerns about the safety of some of the FDA-approved medications consumers use on a regular basis, including heartburn medications and blood pressure and heart failure drugs. According to the latest Zantac reports, the drug may produce potentially harmful levels of the carcinogen NDMA when its active ingredient (ranitidine) breaks down. If you or someone you love has been diagnosed with cancer after taking Zantac, contact us today to find out how a Zantac injury attorney can help.
NDMA is an organic compound belonging to a class of extremely potent compounds called N-nitrosamines. NDMA is found at low levels in certain foods, like cured meats and fish, and is also commonly produced as an unintended byproduct of certain manufacturing processes. NDMA was once used in the production of rocket fuel and in other industrial applications, such as cutting oils. Because NDMA has been found to cause cancer in animal studies, the chemical is classified as a “probable human carcinogen.” That means NDMA may increase the risk of cancer in people exposed to the compound above acceptable levels and over long periods of time. This could pose a serious risk for consumers who have taken NDMA-containing Zantac regularly for years, or even decades, to treat heartburn or acid reflux.
The FDA has been investigating NDMA and other harmful nitrosamine impurities in pharmaceutical drugs since 2018, when it was discovered that certain generic versions of the angiotensin II receptor blockers (ARBs) valsartan, losartan and irbesartan, used to treat high blood pressure and heart failure, unexpectedly contained NDMA, as well as N-nitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). This finding led to numerous high-profile recalls of generic valsartan, losartan, irbesartan drugs.
The recall of all prescription and over-the-counter Zantac and ranitidine products was announced by the FDA in April 2020, in the midst of an ongoing investigation into NDMA contamination in ranitidine-based medications. The presence of NDMA in Zantac was first discovered in 2019 during routine testing by an independent laboratory called Valisure, which found NDMA in ranitidine at levels that exceeded the FDA’s acceptable daily intake limit. “Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the ‘inherent instability’ of the ranitidine molecule,” Valisure reported in the summer of 2019. “This means that all manufacturers, brand or generic, and all lots of ranitidine-containing medications are affected and could generate very high levels of NDMA in the human body.”
In September 2019, the FDA issued a warning about the potential risk of NDMA exposure from Zantac and advised users to consider alternative treatments for their heartburn and acid reflux. Initially, the FDA reported that NDMA levels in some ranitidine products may increase over time and when the products are stored at higher than room temperatures. Upon further investigation, the FDA determined that NDMA levels increase in ranitidine products even under normal storage conditions and may increase significantly in ranitidine samples stored at higher temperatures, including during handling by customers. The agency also confirmed that the older a ranitidine product is, or the longer it has been since the product was manufactured, the higher the level of NDMA. The FDA warned that “These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
Zantac belongs to a class of medications called histamine-2 (H2) blockers, which are designed to decrease the amount of acid produced by the stomach. Prior to its recall, Zantac was available in both an over-the-counter formulation approved to treat and relieve heartburn associated with acid indigestion and sour stomach, and a prescription formulation approved to treat gastroesophageal reflux disease (GERD) and to treat or prevent ulcers of the stomach and intestines. Zantac was originally approved by the FDA in the early 1980’s and was available for consumer use for more than three decades before it was recalled. Unfortunately, consumers who regularly took prescription or over-the-counter Zantac for heartburn, acid reflux, GERD or stomach ulcers may now be at risk for bladder cancer, stomach cancer, gastric cancer, pancreatic cancer or another type of cancer. Speak to an experienced Zantac cancer lawyer as soon as possible if you took Zantac and have since been diagnosed with cancer.