Why did it take so long to notice that Zantac had carcinogenic ingredients?
Sanofi is recalling the popular heartburn drug Zantac. The generic name for the drug is Ranitidine. Apparently, the medication may contain a cancer-causing chemical that has already been detected in certain blood pressure medications. The Food and Drug Administration (FDA) is still investigating whether the chemical is at a concentration to pose a health risk.
The FDA has introduced a new method for detecting some chemicals, such as NDMA:
10/16/2018: UPDATE - FDA releases additional NDMA/NDEA detection method
See https://www.fda.gov/media/117807/download for details of the new process.
This has detected NDMA where previously it wasn't detected.
Wikipedia states:
In October 2019, the U.S. Food and Drug Administration (FDA) observed that a third-party laboratory was using higher temperatures in its tests to look for nitrosamine impurities. The NDMA was generated by the added heat but the higher temperatures were recommended for using a gas chromatography–mass spectrometry (GC/MS) method to test for NDMA in valsartan and angiotensin II receptor blockers (ARBs).[64] The FDA stated that it recommends using a liquid chromatography-high resolution mass spectrometry (LC-HRMS) testing protocol to test samples of ranitidine.[65] Its LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples.[13] The FDA provided additional guidance about using another liquid chromatography-mass spectrometry (LC-MS) method based on a triple-quadrupole MS platform.[13][66]
