While the popular heartburn drug Zantac was taken off the market only recently by the FDA, the contamination problems that led to its market removal may have existed for decades.
New research indicates the active pharmaceutical ingredient may form N-nitrosodimethylamine (NDMA) based on levels of exposure to oxygen and humidity, suggesting contamination has likely been an issue for decades.
Zantac (ranitidine) has been a widely used treatment for heartburn and acid reflux, becoming the first medication to surpass $1 billion in annual sales in 1988. However, federal regulators have now required Zantac recalls for all versions of the ranitidine-based medication, after discovering that the drug is inherently unstable and may produce high levels of the cancer-causing chemical byproduct NDMA.
In a study published last week online in the Chemical and Pharmaceutical Bulletin, Japanese researchers looked at the storage of Zantac under high temperatures to better try to determine how it impacts ranitidine and the formation of NDMA in the pills. This was not a surprising development for those who've been following the news about Zantac and ranitidine equivalents. However, the Japanese research added a potentially new and explosive twist to the investigation into Zantac's contamination.
They determined that oxygen levels and humidity may play a factor in the formation of the toxic chemical. This is a significant development and may signal that the drug's problems are not of recent origin.
In this new study, Japanese researchers set out to investigate the link between NDMA formation in ranitidine and temperatures. They tested two different, unnamed brands, which were stored under accelerated conditions at 104 degrees Fahrenheit and 122 degrees in 75% humidity for eight weeks. According to the findings, the amount of NDMA in the pills increased substantially, from 0.19 parts per million (ppm) to 116 ppm, and from 2.89 ppm to 18 ppm.
“The formation of NDMA that exceeded the acceptable daily intake limit (0.32 ppm) at the temperature used under accelerated storage conditions clearly highlights the risk of NDMA formation in ranitidine formulations when extrapolated to storage under ambient conditions,” the researchers determined.
They also found, however, that “environmental factors such as moisture and oxygen are involved in the formation of NDMA in ranitidine formulations.”
This new development will play a role in pending Zantac lawsuits in which consumers who took Zantac and ranitidine thinking it was a safe and effective treatment for heartburn and acid reflux. Zantac and ranitidine users have contracted a wide variety of cancer including breast cancer, testicular cancer, kidney cancer, stomach cancer and other health problems following years of exposure to NDMA in Zantac.
Once again, the pharmaceutical industry has placed profits over people and endangered the lives of countless innocent consumers who trusted their doctors and the pharmaceutical industry to provide safe and effective medicine for their illnesses.
If you or a loved one have been using Zantac or ranitidine and contracted cancer, please contact me immediately for a free initial consultation.