Ranitidine products can produce unacceptably high levels of a cancer-causing chemical when exposed to heat for as little as five days, according to an analysis cited by Bloomberg.
Since September, when the FDA warned that some ranitidine products — which are used to treat heartburn — contain N-nitrosodimethylamine, or NDMA, a human carcinogen, the agency has tested ranitidine products and found levels of NDMA that range from safe to dangerously high. This has led to uncertainty over how NDMA contamination happens and whether or not ranitidine can be consumed safely, according to Bloomberg.
Emery Pharma, an Alameda, Calif.-based independent drug-testing lab, tested samples of ranitidine products and found that when they were exposed to heat, the level of NDMA increased gradually. The analysis found that NDMA could be formed with limited exposure to heat, such as while the drug was in a hot car or delivery truck.
“I am worried that if it just sits at home at room temperature, it could gradually generate NDMA,” Ron Najafi, PhD, CEO of Emery, told Bloomberg.
Emery Pharma filed a citizen petition with the FDA Jan. 2, asking the agency to suspend all sales of ranitidine products, to recall all products already on the market and to require stability testing before ranitidine products are sold, according to Bloomberg.
The lab also said ranitidine products should be shipped in temperature-controlled vehicles and carry warnings that potential cancer-causing byproducts can be formed if the drug is exposed to heat.
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