Two new studies conducted by the independent pharmacy Valisure appear to confirm the finding that Zantac may be a significant source of exposure to the carcinogen NDMA and that the presence of NDMA in Zantac may be due to the fundamental instability of the heartburn drug’s active ingredient, ranitidine. In spite of the FDA’s initial classification of NDMA as an impurity that may occur in ranitidine medications subjected to certain storage conditions, Valisure’s research demonstrates just how easily ranitidine can convert to NDMA in the human body under simulated gastric conditions occurring in the stomach and digestive system. If you took Zantac for heartburn or acid reflux and have since been diagnosed with bladder cancer, kidney cancer, breast cancer, prostate cancer or another type of cancer, contact us as soon as possible to find out if you qualify for a Zantac cancer claim.
It was Valisure that first identified ranitidine as a potential cancer risk. The finding came in the midst of a wave of recalls affecting the blood pressure drugs valsartan, irbesartan and losartan, which were found to contain N-nitrosodimethylamine (NDMA) and other cancer-causing impurities. Reports suggest that the generic hypertension medications may have been contaminated with NDMA for years, potentially subjecting longtime users to an increased risk of kidney cancer, liver cancer and other cancers. Since 2005, NDMA has been classified as a probable human carcinogen, which means exposure to the chemical could cause cancer in humans. As a result of this potential health risk, the FDA has set the maximum acceptable daily intake limit of NDMA at 96 nanograms (ng). However, recalled Zantac and ranitidine pills may have contained NDMA at levels far above the limits the FDA considers “safe,” which means former Zantac users may too be at risk for cancer.
In September 2019, Valisure petitioned the FDA to remove all ranitidine drug products from the market, after independent testing found high levels of NDMA in Zantac and all ranitidine-based medications. Unlike the NDMA in valsartan, which is believed to have occurred as a result of changes made to the manufacturing process, Valisure attributed the unexpected presence of NDMA in Zantac to the “inherent instability” of the ranitidine molecule. This, the pharmacy warned, meant 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.” The FDA responded by issuing a press release indicating that “some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.”
It wasn’t until April 2020 that the FDA finally requested the removal of all ranitidine (Zantac) products from the market due to the potential health risks associated with exposure to high levels of NDMA in Zantac. The FDA indicated at that time that “the [NDMA] 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.” The agency also confirmed that NDMA levels in ranitidine increase even under normal storage conditions and that the older the drug is or the longer it has been since the drug was manufactured, the higher the level of NDMA. This, the FDA warned, “may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
Since the FDA’s recall announcement was issued nearly a year ago, additional research appears to confirm Valisure’s initial findings that the presence of NDMA in Zantac is, in fact, an inherent risk of ranitidine that can occur in the human body when the drug is used as intended. In a research letter published late last month in JAMA Network Open, researchers from Valisure outlined the process by which ranitidine converts to NDMA under simulated gastric conditions the drug would encounter as it passed through the human body. The study authors found that, after being subjected to these conditions for two hours, a single 150 mg Zantac tablet converted to a minimum of 947 ng of NDMA and a maximum of 320,000 ng – well above the FDA’s acceptable daily intake limit of 96 ng of NDMA.
Another study published the same day in MedRxiv found a connection between Zantac users and an elevated risk of several different types of cancer, including thyroid cancer, bladder cancer, breast cancer and prostate cancer, when compared to other heartburn medications that do not contain the active ingredient ranitidine. “The data published today strongly supports decades of research that ranitidine is fundamentally unstable, can form NDMA in a variety of conditions including in the human body, and could be carcinogenic and toxic to humans,” said David Light, founder and CEO of Valisure, and one of the lead study authors, in a press release issued on January 29. “These findings underscore the vital importance of additional quality assurance testing of on-market drug products.”