After months of deliberation, the Food and Drug Administration has asked all manufacturers of a particular heartburn medicine known as ranitidine, sold under several brands including Zantac, to withdraw their drugs because “unacceptable levels” of a possible carcinogen may develop in the pills over time.
Specifically, the agency determined that levels of NDMA, an organic chemical that was once used to make rocket fuel and is an unintended byproduct of certain chemical reactions, may gradually increase and can increase significantly when stored in higher heat than room temperature.
And as the current level of “heartburn” over current events rises, another ‘player’ leaves the field. A great safety based data point to stand in counterpoint to the new …anecdotally (I didn’t say ‘magic’) based approval paradigm.
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