The Problem with Zantac
The problem with Zantac is that recent lab testing of ranitidine (Zantac’s listed active ingredient and its generic form) found that Zantac contains dangerously high levels of a chemical called NDMA. This contaminant is known to cause cancer.
In September 2019, the U.S. FDA issued a public safety warning regarding Zantac’s possible cancer risks. Following that FDA safety warning, Zantac’s maker, as well as others who manufactured ranitidine products, promptly pulled the product from drugstore shelves across the country.
Zantac Indications for Treatment
Zantac (ranitidine) belongs to a family of drugs known as histamine-2 or H2 blockers. Ranitidine and other H2 blockers are often called “antacids.” They are designed to work by decreasing digestive acid in the stomach. Over-the-counter (OTC) versions of Zantac were often used to treat or prevent heartburn or gastroesophageal reflux disease (GERD). Some doctors prescribed Zantac for severe heartburn and more serious conditions such as stomach or intestinal ulcers and Zollinger-Ellison syndrome.
First released as a prescription drug in the U.S. in the early 1980s, Zantac and generic ranitidine were available in both prescription and OTC form. Zantac was developed and patented by the European drug maker Glaxo (formerly known as GlaxoSmithKline or GSK). The U.S. FDA first approved Zantac as a prescription drug in 1983. GSK spent millions of dollars aggressively promoting the drug to both doctors and the public.
First Drug to $1 Billion in Sales
Zantac became one of the best-selling drugs in pharmaceutical history. It was the first drug to reach $1 billion in annual U.S. sales. Key to Zantac’s marketing strategy was an emphasis on efficacy as well as safety. The latter sales point has proven, tragically, to be false.
NDMA Contamination renders Zantac Cancerous
The Zantac cash cow for GSK stopped producing last year when testing showed NDMA contaminated the drug. N-Nitrosodimethylamine is an unstable organic chemical which is usually created unintentionally as a byproduct of certain industrial processes. NDMA has been recognized as a human carcinogen at least since the 1970s. It is highly toxic to the human body, in particular the liver. It is so toxic, in fact, that Dimethylhydrazine — the “D” in NDMA — is used in the creation of rocket fuel.
Overwhelming evidence has shown that NDMA causes cancer. No defender of Zantac will be able to dispute that NDMA is a carcinogen. It has caused cancer in virtually every animal lab test performed on it in the last 40 years.
Even EPA admits NDMA Cancer Risk
NDMA is listed as a potent human carcinogen by many agencies, including the World Health Organization (WHO), the International Agency for Research on Cancer (IARC), the U.S. Environmental Protection Agency (EPA), and other chemical regulatory bodies. Even the U.S. CDC — which only just this month acknowledged what most holistic doctors have known for decades, that mercury amalgams in dental fillings can cause health problems — has acknowledged the risks of NDMA, even at low doses.
Gastric and Colorectal Cancer
Recent studies by WHO have also linked NDMA to gastric and colorectal cancer.
NDMA found in consumer products has prompted many safety recalls in the last few years — some voluntary, some by FDA request. Most recently, NDMA contamination recalls concerned the popular blood pressure drug, Valsartan.
In 2018, several Chinese makers of generic Valsartan discovered their drug compounds were contaminated with unsafe levels of NDMA. That contamination was believed to be caused by a change in the manufacturing process. It led to a massive recall of generic Valsartan.
Valisure Pharmacy Discovers NDMA Contamination
The discovery of NDMA in generic Valsartan in 2018 caught the attention of a Connecticut-based pharmaceutical lab, Valisure, which performs quality testing on consumer drugs. In spring 2019, Valisure performed its own testing of various antacid drugs, in order to test them for NDMA. Those test results shocked many, though ranitidine was suspected way back in the 1980s of reacting with nitrite in the stomach to produce NDMA.
Valisure’s testing found ranitidine contained highly dangerous levels of NMDA. While FDA set the maximum safe level of daily NDMA exposure at 96 nanograms (ng), Valisure’s testing found that one OTC Zantac tablet contained a shocking 2,511,469 ng of NDMA. That is approximately 26,000 times the maximum daily limit of NDMA.
Valisure promptly reported its testing results to the FDA in July 2019 in a citizen petition which said the NDMA formation was likely a chemical reaction caused by the inherent instability of the ranitidine molecule.
In September 2019, the FDA announced results of its own recent tests on ranitidine. The FDA’s laboratory tests also found NDMA in ranitidine medications, but at much lower levels than the Valisure tests.
We believe that, whether purposefully or not, the FDA’s tests were flawed. The agency failed to use sodium nitrate, which we think everyone will eventually agree is critical for reliable results. But even the “low levels” of NDMA found in the FDA’s flawed testing were considered “unacceptable.” They led to a public safety warning.
Retail stores Pull Zantec from Shelves
The FDA safety warning triggered an immediate reaction from retailers and ranitidine makers. CVS, Walgreens, Rite Aid, Walmart, and other major stores all stopped selling Zantac and its generic equivalents. Generic manufacturers also recalled their products in response to the FDA’s belated warning. (Without Valisure’s taking the testing initiative, would the FDA ever have found the cancer problem? How many more people might have gotten cancer from Zantec?)
FDA’s Belated Zantac Recall
Leacing from the rear as the FDA often does, the agency finally ordered a Zantac recall, calling it “voluntary” to better serve their corporate masters.