Carcinogen in heartburn drug may build in storage, lab finds

Emery Pharma, an independent laboratory in Alameda, CA, says its testing indicates that levels of NDMA, a probable human carcinogen, can increase in ranitidine (Zantac) when exposed to heat for as few as 5 days.

Emery Pharma, an independent laboratory in Alameda, CA, says its testing indicates that levels of NDMA, a probable human carcinogen, can increase in ranitidine (Zantac) when exposed to heat for as few as 5 days. According to Emery, a combination of heat and time can cause NDMA levels in the heartburn drug to increase to unacceptably high levels, potentially after being packaged and analyzed by their manufacturers. Emery filed on January 2 a Citizen Petition asking FDA to suspend all sales of ranitidine-containing products, to recall those that are already on the market, and to require stability testing before they can be sold in the future. Additionally, the lab says the drug should be shipped in temperature-controlled vehicles and include warnings that potential cancer-causing byproducts may be produced if it is exposed to heat. "The more you heat it, the more NDMA you generate," said Emery CEO Ron Najafi in an interview. "I am worried that if it just sits at home at room temperature, it could gradually generate NDMA." An FDA spokesperson said the agency will review the citizen petition and respond directly to Emery. He said the agency is working with manufacturers to ensure a safe and high-quality drug supply.