A recently released study by independent testing lab Emery Pharma claims that popular heartburn medication Zantac produces dangerously high levels of the probable carcinogenic chemical NDMA when exposed to heat. The laboratory is now calling on the U.S. Food and Drug Administration (FDA) to recall all versions of this popular drug. This is one of the latest developments in the Zantac cancer scandal.
Lab Results Suggest NDMA Levels Can Rise After Manufacturer Analysis
According to the study by Emery Pharma, NDMA levels can rise in Zantac long after the manufacturer has analyzed samples to make sure a batch is safe to release. In an article by Bloomberg, Emery CEO Ron Nafaji told the magazine that “The more you heat it, the more NDMA you generate. I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”
The results of the Emery tests are based on an analysis of three ranitidine samples. The FDA has capped the limit for safe levels of NDMA at 96 nanograms. During these tests, a high dose of ranitidine exceeded this limit after five days of exposure to temperatures of 158 degrees Fahrenheit (70 degrees Celcius). The NDMA levels in that same sample rose to 142 nanograms after 12 days.
A test using lower temperatures also found increases in NDMA levels. An identical sample was tested at 77 degrees Fahrenheit (25 degrees Celcius) and NDMA levels increased to 25 nanograms over a 12-day period.
This poses a serious problem to Zantac users, according to Najafi – especially those who take multiple doses of Zantac each day. These multiple-dosage users are at an increased risk of exposure to higher levels of NDMA.
Emery Pharma Files Citizens Petition with FDA
Emery filed a Citizen Petition with the FDA on Thursday, January 2, 2020. The lab has asked the FDA to suspend sales of all ranitidine products, to recall those that are already available to the public, and to require stability testing before the sale of ranitidine products can resume.
Emery has also requested that ranitidine be shipped in temperature-controlled vehicles and that warning labels be added to the product regarding the possibility for carcinogenic byproducts that are potentially produced during exposure 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 in the same phone interview with Bloomberg. “Or else you may be exposing yourself to large quantities of this cancer-causing agent.”