This Theory Would Explain Why NDMA Was Not Found To Be A Problem At Zantac Manufacturing Sites
The fact that Zantac contains NDMA (nitrosamine impurity called N-nitrosodimethylamine), a probable human carcinogen, was the subject of a September 13, 2019 FDA Press Announcement, "Statement alerting patients and health care professionals of NDMA found in samples of ranitidine". Since then there has been uncertainty about how this Zantac NDMA problem went undetected for so many years. Ranitidine is the active ingredient in Zantac, which was initially approved by the FDA in 1983.
Several months later, there is a new theory about how that could have happened. From this January 2, 2020, Bloomberg news report, "Carcinogen in Heartburn Drug May Build in Storage, Lab Finds", we are presented with this possible scenario:
The heartburn medicine Zantac appears to produce unacceptably high levels of a cancer-causing chemical when exposed to heat for as little as five days, according to a testing laboratory....
New testing by an Alameda, California-based independent laboratory called Emery Pharma found that a combination of heat and time can raise levels of NDMA, potentially while drugs are sitting in packaging well after being analyzed by their manufacturers....
“The more you heat it, the more NDMA you generate,” Emery CEO Ron Najafi said in a telephone interview. “I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”
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That January 2020 news report, however, includes two points which may cause some people to view this new theory about the Zantac NDMA problem with some skepticism:
- Emery Pharma was hired by the pharmacy company Valisure LLC, which petitioned the FDA to recall all forms of Zantac; and,
- Emery CEO Najafi works as an expert witness in litigation alleging that Zantac contains NDMA.
So what comes next? The Bloomberg article provides this insight:
On [January 2, 2020], Emery filed a Citizen Petition with the FDA, asking the agency to suspend sales of all products containing ranitidine, to recall those that are already on the market and to require stability testing before they can be sold in the future. The medicine should also be shipped in temperature-controlled vehicles and carry warnings that potential cancer-causing byproducts may be produced if it is exposed to heat, the lab said.
As background, typically the FDA will review a filed Citizen Petition and eventually respond directly to the group that filed it.
So we will have to wait to see what the FDA thinks about this Zantac NDMA causation or mechanism of action theory developed by Emery Pharma.
Here is a related article we published previously: "Zantac FDA Warning In September 2019 Leads To Lawsuits For Patients Diagnosed With Cancer".
Our law firm is currently investigating possible Zantac cancer lawsuits for personal injury and wrongful death cases.
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