U.S. FDA moves to remove all versions of heartburn drug Zantac from market

Last Updated: 2020-04-01

By Reuters Staff (Reuters) - The U.S. Food and Drug Administration said on Wednesday it was requesting makers of all versions of heartburn drug Zantac to remove the drugs from the market immediately due to the presence of a probable carcinogen.

French drugmaker Sanofi SA's Zantac and some generic versions of the treatment, also known as ranitidine, have been recalled over the last year due to possible contamination with N-nitrosodimethylamine (NDMA).

The FDA said it had determined that NDMA in some ranitidine products increases over time and when stored at higher than room temperatures, resulting in consumer exposure to unacceptable levels of the impurity.

"We didn't observe unacceptable levels of NDMA in many of the samples that we tested," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

"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."

The FDA also said consumers taking over-the-counter ranitidine should stop taking the drug and not buy more, and those taking prescription ranitidine should ask their doctor about other options before discontinuing treatment.