What patients should know about NDMA impurities in ranitidine

What patients should know about NDMA impurities in ranitidine

• Not all ranitidine medicines marketed in the U.S. are being recalled.
• FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 ng or 0.32 parts per million for ranitidine).
• Some companies have recalled ranitidine based on tests showing levels of NDMA above the acceptable daily intake, while some have recalled without doing testing based only on the potential for NDMA in the drug.
• Consumers may not know if the over-the-counter (OTC) ranitidine in their homes contains NDMA above the acceptable daily intake level because these recalls have been to the retail level, meaning they were only removed from store shelves. However, the NDMA levels we’ve found are similar to the levels you would expect to be exposed to if you ate common foods like grilled and smoked meats.
• Consumers taking OTC ranitidine may consider using other OTC products approved for their condition. To date, FDA’s tests of samples of alternatives show no NDMA in: Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole).
• Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

Certain drug manufacturing processes pose a risk for forming genotoxic impurities. For decades, FDA has provided guidance and recommendations for controlling impurities in drug substances and manufacturers have had an ongoing responsibility to test for impurities based on an understanding of their manufacturing process.