Regulatory Guidance

Possible carcinogen found in popular heartburn meds

Sep 16, 2019

Regulators in the U.S. and EU are taking a closer look at medication containing ranitidine after the presence of a probable carcinogen was found in several samples.

On Friday, the FDA announced that traces of N-nitrosodimethylamine (NDMA) were detected in the widely used heartburn medication by an online pharmacy called Valisure that tests drugs for impurities. Valisure reported that it found NDMA in both Sanofi’s branded Zantac version of the drug as well as generic versions. The agency did not report which drugs exactly contained traces of NDMA but said that its own testing found different and lower amounts of the chemical.

Valisure also reported that because ranitidine is unstable, the toxin can form on its own, and that the problem may not be related to manufacturing.

NDMA is one of the toxins related to the recent wide-spread recall of valsartan, a heart medication.

The FDA said it is expanding its testing of medications for these impurities, and that it could soon require new testing during the manufacturing process for potential toxins.

Read the full Reuters report.

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