Wednesday, April 1, 2020 - The United States Food and Drug Administration announced today that it is urging manufacturers of ranitidine-based drugs, including Zantac, to pull their prescription and over-the-counter products from shelves immediately. The request is the latest development in an ongoing investigation into N-Nitrosodimethylamine (NDMA), a probable human carginogen, that has been found in ranitidine medications.
RxWatch has been following the developments of this investigation closely because of the growing mountain of evidence showing Zantac and similar ranitidine-based drugs may contribute to or cause users to develop cancer.
In late 2019, a recall was initiated by the FDA after Valisure independent pharmacy found NDMA in several samples of ranitidine-based products that were manufactured in several different factories. Valisure scientists issued a citizens' petition to the FDA saying that the "inherent instability of the ranitidine molecule" leads to a chemical breakdown, which results in production of NDMA.
"Combined with other data from Valisure and the scientific works of Stanford University and others, the evidence presented shows this instability and the resulting NDMA occurs in the conditions representative of those in the human body and builds a compelling case for ranitidine being a likely human carcinogen," Valisure representatives said in the petition.
In the FDA's initial response, it recommended utilizing testing conducted at lower temperatures. When it conducted tests at these temperatures, it did not find excessive levels of NDMA. Valisure suggested that testing should be done at temperatures similar to the human body as it breaks down the drug. The information released today by the FDA indicates that higher temperatures are, in fact, a likely culprit for the breakdown into NDMA.
The release reads, "The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
"... New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit."
In addition to requesting manufacturers remove ranitidine products from shelves, the FDA is advising people who take ranitidine, either by prescription or purchase it over the counter, to consult with their medical care provider to devise a plan to best stop taking it, and to dispose of products they already have. There are a number of alternative medications, including Pepcid, Tagamet, Nexium, Pravacid, and Prilosec, that are used to treat the same conditions, but that do not contain ranitidine.
The FDA also adds, "In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency's recommended steps, which include ways to safely dispose of these medications at home."
If you have taken Zantac regularly and been diagnosed with cancer, visit www.zantacantacidcancerlawsuit.com or call 1-800-RxWATCH for a free, no-obligation consultation. We fight for consumers when drug companies profit from dangerous medications.
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