Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns.
In a citizen petition to the FDA, Emery Pharma warned that the medicine could be unstable and generate NDMA at higher temperatures. While seemingly stable at room temperature, “the ranitidine molecule … under elevated temperatures (158 degrees F.) progressively accumulates NDMA,” the company said.
Transport and storage of the drug could pose risks to consumers if the stability test findings are correct. “The drug is very likely exposed to elevated temperature during shipment and commercial storage as well as post-purchase storage by consumers,” Emery warned, urging the FDA to suspend all products containing ranitidine and require stability testing.
The agency flagged the link between NDMA and elevated temperatures last year when an online pharmacy reported extremely high levels of NDMA. The agency later urged manufacturers not to use high-temperature tests because they generated NMDA.