The online analytical pharmacy, Valisure, advised the U.S. Food and Drug Administration (FDA) of the presence of a cancer-causing chemical in certain batches of Zantac and its generic, ranitidine in 2019.
Valisure’s discovery sparked waved of changes. For example, several major retailers removed the prescription and over-the-counter formulas of Zantac from their shelves. Sanofi (Zantac’s brand-name manufacturer) and 14 generic manufacturers recalled the medication in the United States
On April 1, 2020, the FDA requested that the manufacturers of all ranitidine products remove prescription and over-the-counter versions from the market due to public health risk. According to the FDA, people should consume no more than 96 nanograms of NDMA per day, but Valisure’s testing revealed that some Zantac formulas contained over 3,000,000 mg per tablet. Although the FDA stated that Valisure’s high temperature testing process may have increased NDMA levels in the samples, a low-heat method still showed unacceptable levels of the contaminant.
“Valisure tests all batches of all its medications for quality and consistency issues and through such tests detected extremely high levels of N-Nitrosodimenthylamine (NDMA), a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.” – Valisure Citizen Petition on Ranitidine 2019
The Agency for Toxic Substances and Disease Registry (ATSDR) does not have adequate studies to determine how exposure to NDMA in food or drink might affect humans long term. Evidence shows that NDMA is extremely toxic to the liver and other vital organs. The toxicity of NDMA can also cause cancer and death in animals.
According to a public health statement issued by the ATSDR, “Although there are no reports of NDMA causing cancer in humans, it is reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.”
With these discoveries and other research by our attorneys, Childers, Schlueter & Smith may be able to help you. We are actively pursuing Zantac claims for those dozens of patients. If you have been injured after taking Zantac, please give us a call for a free consultation. You can find further information about Zantac right here on our website.