The H 2 blocker ranitidine (Zantac) has been withdrawn from the U.S. market because of concerns over levels of the contaminant N-nitrosodimethylamine, which can increase with time and temperature, posing a risk of cancer. Patients should be told to discard all products containing ranitidine.
Will ranitidine be back on the market?
Zantac will be back on the market when the manufacturer, Sanofi, can confirm to the U.S. Food and Drug Administration (FDA) that the NDMA levels in the drug are stable and do not pose a threat to consumers. Only then will the FDA “consider” making Zantac and other ranitidine products available.
Why has ranitidine been withdrawn?
Ranitidine products (Brand names including Zantac®) were voluntarily withdrawn by manufacturers in October 2019 due to the presence of low levels of an impurity called NDMA. The European Medicines Agency has since confirmed its recommendation to suspend all ranitidine medicines in the EU.
