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The FDA is assessing the risk of people taking Zantac and its generic versions after the discovery of a probable carcinogen in the treatment of heartburn. N-nitrosodimethylamine, also known as NDMA, is the nitrosamine impurity detected at low concentrations, says CNN. The agency has investigated such impurities in drugs for blood pressure and heart failure and has issued recalls in the past. There is no reminder for now in this case, however. The tests indicate that the amount of NDMA contained in ranitidine, generic name of the drugs reducing stomach and acid burns, could only slightly exceed the amounts found in foods such as meats and products. dairy. USA today.
European agencies said they were also investigating. The FDA had been alerted by Valisure, an online American pharmacy. Valisure, who tests the drugs sold, has asked the FDA to recall Zantac and the generics containing NDMA, by Bloomberg. Zantac is manufactured by Sanofi. Valisure has qualified the excessive levels, with which the FDA does not agree. "We do not think this poses an immediate risk to human health," said an FDA spokesman. "So we will have a process underway to determine if any reminders are needed." (Read more stories about the Food and Drug Administration.)
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