Zantac Contamination Caused by Heat Exposure
An independent laboratory could have identified what causes the contamination of ranitidine (Zantac) by the known carcinogen N-nitrosodimethylamine (NDMA). Ranitidine products which are antacid products sold in the U.S. have been in the news lately as potentially carcinogenic due to the discovery of unsatisfactory levels of NOMA
Since early winter of 2019, the FDA announced a number of voluntary recalls directed at manufacturers and distributing outlets for ranitidine products present in the United States. This is following the discovery of NOMA at quite unacceptable levels. The FDA ‘s advice to pharmaceutical companies that test their own drugs following production that they do not release any on to the United States market if it is found contamination levels are so high that patients are exposed to levels exceeding 96 nanograms of NOMA daily.
What was first announced by Bloomberg was followed up by a round of new testing by the Alameda based company Emery Pharma which could demonstrate that considering both time and heat they found that these could be the cause of the contamination. The analysis revealed that even just a small amount of heat exposure could be sufficient to bring about an increase in NDMA levels because the drugs became destabilized. A ranitidine sample exceeded the 96 nanogram NDMA limit after 5 days at 158 degrees Fahrenheit (70 Celsius), and when 12 days was up the sample attained NOMA at 142 nanograms. Emery · Pharma put the drugs through testing at a 77 degrees daytime temperature discovered that a sample attained 25 nanograms over a 12 day period.
Emery’s analysis suggested that from just extended exposure to a warm ambient temp. to a delivery time in a hot truck encourages the increasing of NOMA levels throughout the ranitidine product range. The longer it is exposed the higher the chance of the contamination levels rising. This elevates the risk for a patient who may only require one or two doses to exposure oflevels of NDMA far higher than the FDA guidelines.
Consequently Emery filed a Citizen Petition directed at the FDA asking for a complete suspension of all ranitidine products, a compulsory recall of all products presently on the market, testing for the stability of any future products, temperature restricted delivery and more current labels describing the chances of developing carcinogens from heat exposure.