January 9, 2020- Emery Pharma says that recent tests indicate that levels of NDMA – a known carcinogen – in Zantac can increase during storage, especially if the drug is exposed to high heat and even while it remains in the package. The researchers found that stored Zantac medication exposed to high heat can produce unacceptably high levels of NDMA in as few as five days.
Based on these findings, Emery Pharma has urged the FDA to recall Zantac and all similar ranitidine drugs. A Citizen Petition was filed by Emery Pharma, requesting that the FDA suspend sales and recall all ranitidine-based products due to the threat of NDMA exposure to consumers.
Valisure had filed a similar Citizen Petition early last October 2019 after its tests indicated that heat from manufacturing could create high levels of NDMA. According to Valisure, they tested a number of ranitidine-containing heartburn medications, and all of the batches tested, regardless of dose forms, “detected extremely high levels” of NDMA in every lot.
In response, the FDA asked drug-makers to test all batches of ranitidine-containing products that they produce to ensure consumers are not exposed to dangerous levels of NDMA.
Many of the manufacturers discontinued the production and sales of their ranitidine-containing drugs after conducting these tests.
Reference: Palmer, Eric. “Lab Finds NDMA in Zantac Can Develop during Storage.” FiercePharma, 3 Jan. 2020, https://www.fiercepharma.com/manufacturing/lab-finds-ndma-zantac-can-develop-during-storage-bloomberg.