FDA seeks withdrawal of heartburn drugs due to new carcinogen concerns
The FDA on Wednesday requested that all manufacturers of drugs containing ranitidine (commonly known as Zantac and used for heartburn) remove all prescription and over-the-counter (OTC) versions from the market because the carcinogen N-Nitrosodimethylamine (NDMA) has now been found to increase significantly in samples stored at higher temperatures.
The announcement is the most serious in a chain of FDA safety advisories related to NDMA in ranitidine medicines following a series of recalls of Zantac and other ranitidine drugs, and as the agency said last November that the NDMA levels in such drugs “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
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