Ranitidine (Zantac) Contains The Potent Carcinogen NDMA, FDA Quickly Downplays The Issue Even Though More Research Is Needed
Ranitidine, which is primarily sold under the brand name Zantac, has generated a flurry of news recently due to the discovery that it is contaminated with N-nitrosodimethylamine (NDMA), which is a potent carcinogen. Most manufacturers temporarily recalled products containing ranitidine, but now the Food and Drug Administration (FDA) is seemingly downplaying the entire incident, saying it contains just as much NDMA as a grilled cheese sandwich or smoked meat, and has allowed manufacturers to continue selling ranitidine. The FDA and the news in general ignored the fact that ranitidine’s intrinsic mechanism of action may cause breast cancer according to a 2008 study. This article will explore these topics in-depth.
Apparently Zantac is among the 100 top selling prescription drugs in the United States, with 15 million prescriptions for Zantac written in 2016 alone. This does not include all of the Zantac which was obtained over the counter (OTC), or sales of other brands of medications which contain ranitidine. The reason ranitidine is so popular is that it reduces stomach acid via acting as an H2 histamine receptor antagonist and blocking the release of histamine, which decreases the amount of acid released by stomach cells.
However, a 2008 study found that ranitidine may increase the risk of breast cancer due to its mechanism of action. It was hypothesized that H2 histamine receptor antagonists may increase prolactin concentrations, which could increase the risk of breast cancer in post-menopausal women since higher prolactin levels are associated with increased breast cancer risk for that group.
The scientists who conducted this study also investigated the risk of cimetidine and famotidine, which are alternative stomach acid drugs. It was found that cimetidine and famotidine were not associated with any increased cancer risk, while ranitidine caused a 2.4 fold increase in the risk of breast cancer, specifically ductal carcinoma.
Unfortunately, there has been little to no research on this theory since the 2008 paper, so it continues to be unknown if ranitidine intrinsically causes breast cancer via increasing prolactin levels. Indeed, the current frenzy over ranitidine has nothing to do with this theory. That being said, there are at least anecdotal reports of ranitidine users getting ductal carcinoma, the exact cancer stated in the 2008 paper.
The current public hysteria over ranitidine is due to the fact that NDMA was found within ranitidine. Specifically, drug testing firm Valisure found 3 million nanograms of NDMA in each ranitidine tablet, way beyond the safety limit of NDMA which is 96 nanograms per day. Even worse, similar extremely high levels of ranidine were found in multiple brands, including Zantac, Strides, Equate, and Wal-Zan.
It seems the cause of the NDMA contamination is that the ranitidine molecule contains both a nitrite and a dimethylamine group, which can combine into NDMA. According to Valisure, conditions ripe for ranitidine breaking down into NDMA are present within the human body. Also, Valisure claims that ranitidine can react with itself to form NDMA, especially at higher temperatures.
The FDA alerted the public about this NDMA contamination on September 13, which was several days after Valisure submitted their report. The FDA stated that they conducted their own preliminary testing, which showed that NDMA concentrations in ranitidine were about the same as NDMA concentrations in common foods. Also, the FDA said they were not calling for people to stop taking ranitidine-based medications, and issued no mandatory recalls. The only recalls which happened were voluntary.
The FDA then released their test results, which showed that many ranitidine medications were actually within the public safety limit of 96 nanograms per day or 0.32 parts per million (ppm). Several ranitidine medicines exceeded these limits, but not by nearly as much as Valisure’s tests showed. Supposedly, the difference between the FDA’s and Valisure’s results are due to higher temperatures used by Valisure for a GC/MS test, while the FDA used LC-HRMS which does not require elevated temperatures. In other words, the general line of thinking is that Valisure’s high testing temperatures caused spontaneous formation of NDMA, leading to systematic bias in the results.
Also, the FDA tested ranitidine medicine in a simulated stomach environment, and found that NDMA does not form. However, the FDA admits that full testing of ranitidine in the human body is necessary, and that there is some evidence that ranitidine may interact in the body to form NDMA.
Ultimately, the FDA is not banning ranitidine nor telling anyone to stop taking it. Instead, the FDA is testing every batch of ranitidine produced by manufacturers, and as long as the ranitidine is below the safety limit it can be sold publicly. This ignores the possibility that the dimethylamine and nitrite groups in ranitidine may spontaneously turn into NDMA in the body.
The FDA seems to be taking the approach of innocent until proven guilty with ranitidine, as well as playing an active role in suppressing the public frenzy over ranitidine. It seems odd that the FDA is so quick to jump to the rescue of ranitidine and keep it on store shelves, while simultaneously the FDA refuses to approve of life saving medicines like Kratom, Sodium Dichloroacetate (DCA), and nicotine vapes. It can be speculated that ranitidine is treated differently because it rakes in billions of dollars of sales annually, allowing its manufacturers to buy the best lawyers and lobbyists to protect their businesses. The same could be speculated about all of the other drugs manufactured by Big Pharma.
One final note. The FDA says that people who decide to voluntarily cease ranitidine use should take alternatives like Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), or Prilosec (omeprazole). It seems quite odd that the FDA recommends all of these complex medicines but does not recommend Tums, which is simply calcium carbonate and perhaps the safest medicine for reducing stomach acid.