A testing lab wants all forms of Zantac heartburn medication recalled after the discovery of unacceptably high levels of N-Nitrosodimethylamine (NDMA) were found in the drug. The dangerous cancer-causing agent appears to develop as the drug is exposed to heat for as little as five days.
The Food and Drug Administration has been watching Zantac and its generic versions since September when the toxic chemical was discovered in some samples of the medication. Levels of NDMA have ranged from safe to critically high. This wide discrepancy makes it unclear how the contamination is occurring and leaves the FDA wondering if any versions of the medication are safe for consumers.
Emery Pharma is an independent laboratory in Alameda, California, that has discovered that heat raises the level of NDMA after the medication has already been packaged and is sitting on a shelf. This rise of NDMA takes place long after the manufacturer has already analyzed the drug for safety.
Many manufacturers have removed the questionable medications from pharmacy shelves. Sanofi, the maker of brand-name Zantac, has pulled its product. Memorial Sloan Kettering Cancer Center in New York, a primary oncology hospital, refuses to dispense the medication while reviewing the risks. Despite the potential dangers discovered, the FDA has not pushed for a widespread recall.
Under current FDA actions, drug manufacturers have been asked to test Zantac medications after production to determine if a user would be exposed to more than 96 nanograms of the carcinogen per day. Products that produce over the limit are asked not to be released to the public. However, new testing done by the Alameda lab indicates that exposing the drugs to periods of high heat, such as inside a delivery truck, could create problems. According to Emery’s chief executive officer Ron Najafi, “The more you heat it, the more NDMA you generate.” He further expresses, “I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”
Emery was initially hired by Valisure LLC, a pharmacy company that presents itself as a provider of quality-tested medications. Mr. Najafi has appeared in court hearings as an expert witness regarding drug contamination by NDMA in Zantac and its generic forms.
Zantac’s active ingredient, ranitidine, has been under investigation by the FDA in an attempt to discover whether the substance turns into NDMA inside a patient’s body after consumption. Per the agency, testing shows that levels in the medication are similar to levels found in grilled and smoked meats. Drugmakers do conduct tests on new medications being developed, however, Zantac was first approved back in 1983, so any testing back then would not have included today’s technology.
Citizen Petition Filed
Emery Pharma filed a Citizen Petition asking the FDA to stop sales of any product containing ranitidine and to recall such medications already in the marketplace. The petition also requests that stability testing be mandated before these medicines can be sold. Further, the drugs need to be transported in temperature-controlled vehicles and should have warnings of the potential for cancer-causing byproducts to be generated if the medications are exposed to heat.
An FDA spokesperson, Jeremy Kahn, would not give specifics concerning a request filed with the agency. He did say that the FDA will be reviewing the citizen petition and will then directly respond to the filing group.
Emery’s testing was done on three ranitidine samples over time. After only five days of exposure to temperatures of 158 degrees Fahrenheit, the ingredient was found to be over the 96-nanogram FDA limit for NDMA. Twelve full days of the same temperature produced a reading of 142 nanograms of carcinogenic NDMA.
NDMA was produced at lower temperatures, as well. A sample identical to the one mentioned above was subjected to 77 degree Fahrenheit temperatures over a 12-day period, and cancer-causing NDMA rose steadily to 25 nanograms.
Emery Pharma’s Najafi explains that some patients take several doses every day, thus exposing the user to higher levels. “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” He continued, “Or else you may be exposing yourself to large quantities of this cancer-causing agent.”
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- Michelle Cortez. “Carcinogen in Heartburn Drug May Build in Storage, Lab Finds”, Bloomberg, https://www.bloomberg.com/news/articles/2020-01-02/carcinogen-in-heartburn-drug-may-build-during-storage-lab-finds. Accessed January 3, 2019.