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.
“The more you heat it, the more NDMA you generate,” Emery CEO Ron Najafi s. “I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”
Najafi has worked as an expert witness on a number of NDMA drug contamination litigations, including the litigations on NDMA in Zantac and its generic forms.
A Citizen Petition has been 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.
“Our preliminary data indicate that NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage. More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer,” the petition says.
Najafi suggests that these ranitidine-containing products should be shipped and stored using temperature-controlled methods. He also says that the manufacturers and the FDA should continue to conduct stability testing for all products.
FDA spokesman Jeremy Kahn says that the agency will review Emery Pharma’s Citizen Petition and respond directly to the group.
Over the past few months, the FDA has been working to determine whether dangerous levels of NDMA are present in Zantac or its generic forms. Their research has proven to show varying levels of NDMA in products.
Valisure filed a similar Citizen Petition in October after their tests indicated that heat from manufacturing can 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.