FDA Tells Drugmakers To Remove All Versions Of Ranitidine From Market
The AP (4/1) reports the FDA is “telling drugmakers to immediately pull” all versions of ranitidine, a popular heartburn drug, “off the market after determining that a contamination issue with the medications poses a greater risk than previously thought.”
Reuters (4/1) reports “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 stated “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.” In addition, “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.”
HealthDay (4/1) reports “the agency’s order for immediate withdrawal of all ranitidine products means they won’t be available either by prescription or over-the-counter (OTC) in the United States.”