Ranitidine heartburn medications have been under an FDA investigation since last summer.
You may remember last September when generic ranitidine heartburn medication was recalled and pulled from drugstore shelves. Well, now, as the U.S. Food and Drug Administration (FDA) investigation into the drug's ingredients continues, all Zantac medications will be pulled from the market, per a request from the FDA on April 1.
Zantac (ranitidine) contains N-Nitrosodimethylamine (NDMA), which is a probable human carcinogen that could cause cancer when consumed large doses. While the low level of NDMA in the drug was not substantially concerning (NDMA is present in water and in a variety of foods), new evidence suggests that the longer a ranitidine product sits on the shelf, the higher the level of NDMA is raised. Specifically, when packaged samples are stored at high temperatures, or even after a substantial amount of time has passed since the manufacture date, the level of NDMA increases beyond a human's acceptable daily limit.
“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,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said. “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 FDA is requesting that all manufacturers of ranitidine take their products off the market. They are also asking consumers to check their medicine cabinets and dispose of any OTC ranitidine products in their possession, as well as for consumers using prescription ranitidine to discuss a change in treatment option with their doctor.
Ranitidine is used to treat heartburn. At this time, the FDA’s testing has not found NDMA in other drugs that treat the condition, including famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
For more information, visit the FDA's website.
Do you take Zantac or another ranitidine product? Have you found another drug that works just as well in treating heartburn? Tell us in the comments—We'd love to know!