A testing laboratory petitioned the U.S. Food and Drug Administration (FDA) on Thursday to recall all forms of ranitidine, including Zantac. The laboratory, Emery Pharma, said the heartburn medication produces unacceptably high levels of the carcinogen NDMA when exposed to high heat.
“The more you heat it, the more NDMA you generate,” said Emery CEO Ron Najafi. Najafi said that even routine exposure to high heat like in a delivery truck or hot car can be problematic. “I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”
The FDA’s daily intake limit for NDMA is 96 nanograms. Emery exposed a sample of ranitidine to 158 degrees Fahrenheit for five days and it exceeded the FDA limit. Emery found 142 nanograms of NDMA after 12 days at 158 degrees Fahrenheit.
Emery exposed an identical sample to 77 degrees Fahrenheit. The NDMA in the sample steadily increased over 12 days to 25 nanograms.
Emery filed a Citizen Petition with the FDA on Thursday. The petition requests that the FDA stop all ranitidine sales. It also requests they recall all ranitidine products on the market and require stability testing prior to future sales. An FDA spokesman said the agency will review the petition and respond directly to Emery.
Emery said ranitidine should be shipped in vehicles with temperature control and its label should have warnings that carcinogens can form when the medication is exposed to heat.
“Manufacturers should have a strong warning on the label that if the product has been heated above a certain temperature, they shouldn’t use it,” Najafi said. “Or else you may be exposing yourself to large quantities of this cancer-causing agent.”
The U.S. Environmental Protection Agency (EPA) considers NDMA a probable human carcinogen. A September, 2019 FDA safety alert announced that some medications containing ranitidine may contain NDMA. The safety alert led to a rash of Zantac recalls.
NDMA is very toxic to the liver. It can cause liver fibrosis in rats. Rats who are given small doses of NDMA long-term develop liver tumors. Rats are given NDMA by scientists so they develop cancer the scientists can research. NDMA exposure can lead to headaches, fever, nausea and vomiting. Liver, kidney and lung function can be affected by exposure to NDMA.
Connecticut congresswoman Rosa DeLauro (D-CT) also recently asked the FDA to remove all medications containing ranitidine from the United States Market.