Online pharmacy Valisure has become something of a pharmaceutical watchdog for patients. They test all of the medicines that they distribute after their founder, Adam Clark-Joseph, noticed something was off about his regular prescription, and questioned how much the FDA was truly protecting us. His suspicions were right: from 2003 to 2013, the FDA approved 12,100 drugs— and had only tested 4000 of them. They’ve also exposed deceit from trusted companies: Valisure found that Tylenol Rapid Release is slower acting than the coated version.
Part of Valisure’s regular testing involves churning pills in a stomach acid-mimicking solution, warmed to body temperatures. They noticed an enzyme in the human body can create DMA from Zantac, where, when in contact with Sodium Nitrite, a common preservative in processed meats, smoked fish, dairy, and some vegetables, can form NDMA, a probable carcinogen.
The FDA disputes this: they did the same test, and did not get the toxic NDMA results— but they didn’t add Sodium Nitrite. In Valisure’s Citizen’s Petition, they did not say this was the only way Ranitidine could cause cancer- the molecule contains a nitrite and a DMA on its own. Valisure found that one Zantac tablet had over 30,000 times the FDA’s daily permissible NDMA intake limit.
Zantac is not coming back. The FDA announced on April 1st, 2020, that Zantac should be removed from all marketplaces and pharmacies including: Rite Aid, CVS, Walgreens, and Walmart pharmacies. This includes generic Ranitidine tablets, both Over The Counter (OTC) and that from prescriptions. You can no longer buy Zantac.
Valisure investigated Zantac because Ranitidine Syrup was prescribed to the founder’s infant child. They found it can create cancers of the GI, and anywhere on its path Zantac can travel, including mouth cancer, stomach cancer, esophageal cancer, and bladder cancer.
NDMA is a dangerous chemical because it modifies your DNA. A previous FDA study showed that consistent exposure to a drug with a high level of NDMA left 1 out of 8000 patients with Cancer. Many believe that the greatest risk with NDMA from Zantac is that it forms as it travels through your body- and can affect anything in its path. In a study by Stanford University, 10 healthy volunteers took 150mg of Ranitidine once per day. Extremely high levels of NDMA were detected in the urine of participants— this was the first sign of Zantac being linked to bladder cancer.
The FDA announced that all versions of Zantac and Ranitidine must be removed from the market. If you take Zantac Over The Counter, the FDA recommends you stop usage of it- for all patients, including as an Antacid for GERD and Heartburn, and as an anti-inflammatory.
If you take Zantac, or Ranitidine, by prescription, the FDA recommends that you talk to your Doctor about alternatives. If you intend on pursing compensation, here or elsewhere, it is encouraged that you keep your pill bottles, receipts, and evidence of prescription.
Related: Zantac FDA Recall: Do I Have Cancer?