The U.S. Food and Drug Administration (FDA) announced today that it is asking manufacturers to immediately remove all ranitidine (Zantac) drugs from the market.
The FDA determined that levels of the probable carcinogen N-Nitrosodimethylamine (NDMA) in some ranitidine products increases over time and that this may expose consumers to unacceptable levels of NDMA.
Testing lab Emery Pharma petitioned the FDA in January 2020 to remove ranitidine from the market. The lab said unacceptably high levels of NDMA formed in ranitidine when it is exposed to heat. A sample of ranitidine that Emery exposed to 158 degrees Faherenheit for five days contained more than the FDA’s daily limit of 96 ng of NDMA. The same sample contained 142 ng of NDMA after being exposed to the same temperature for 12 days. NDMA levels in a sample of ranitidine that Emery exposed to 77 degrees Fahrenheit steadily rose over a period of 12 days.
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said the FDA Center for Drug Evaluation and Research’s director Janet Woodcock, M.D. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
The U.S. Environmental Protection Agency (EPA) considers NDMA to be a probable carcinogen. Scientists expose rats to NDMA to give the rats cancer which the scientists can then study. Exposure to NDMA can result in nausea, vomiting, headaches and fever. Liver, kidney and lung function can be affected by NDMA.
The Judicial Panel on Multidistrict Litigation formed a multidistrict litigation (MDL) in February in Florida involving 15 Zantac lawsuits. The MDL accuses ranitidine manufacturers of concealing the presence of NDMA in their drugs, false advertising, failure to warn and other claims. MDL plaintiffs claim to have been diagnosed with breast cancer, bladder cancer, colon cancer, esophagus cancer and other cancers.
Over 100,000 claimants are expected by experts to be added to the MDL before it ends. Experts expect the MDL to end in settlement rather than going to trial.