Sunday, August 1, 2021 - Zantac lawsuits may come down to the methods used to test ranitidine for the presence of NDMA, and if it does, Valisure CEO David Light will have some explaining to do. CEO Light‘s firm Valisure was the first to test Zantac for the presence of deadly substances. The online prescription drug testing pharmacy became alarmed at the levels of N-nitrosodimethylamine (NDMA), a probably human carcinogen, contained in Zantac ranitidine tablets. Valisure found as much as 3 million nonograms per tablet, well over the 96 nanograms per tablet the FDA thought would be acceptable in a product that was to be ingested several times per day for years on end. When Light‘s firm made the NDMA discovery, they filed a Citizen‘s Petition with the FDA asking the agency to recall the drug and ban future sales. Valisure‘s condemnation of ranitidine went as far as to say that ranitidine itself could be considered a probably human carcinogen.
Valisure‘s high-temperature testing methods aside for the moment, the ranitidine petition claims that there is a likelihood that the molecule is inherently unstable and could become carcinogenic based on human body heat plus interacting with nitrites found in the stomach according to research conducted by the company in conjunction with prominent university scientists. "Combined with other data from Valisure and the
scientific works of Stanford University and others, the evidence presented shows this instability and the resulting NDMA occurs in the conditions representative of those in the human body and builds a compelling case for ranitidine being a likely human carcinogen." the Citizen‘s FDA Petition wrote. Valisure also stated that while standard drug storage conditions could cause NDMA levels to increase well above the 96 nanograms per tablet, they would not be high enough to cause cancer. "Valisure‘s tests suggest ranitidine can react with itself in standard analysis conditions (e.g. GC/MS oven temperature of 130 degrees Celcius) at high efficiency to produce NDMA at levels well above the permissible daily intake limit for this probable carcinogen. However, this level is not high enough for acute toxicity."
The FDA has a far less condemning stance on ranitidine. The agency claims that the April 1, 2020 ranitidine recall is not due to high levels of NDMA but to the agency being unable to ensure safe temperature conditions and the duration of storage of the product. The FDA test of ranitidine using other than high-temperature producing gas chromography produced NDMA levels right around the 96 NGS per tablet. Scientific American quoted the FDA‘s stance on NDMA testing and concluded that the high-temperature methods used by Valisure could have caused the spike in NDMA. "High levels (of NDMA) may have been a result of the testing method Valisure used, which involves heating the sample. That method is not suitable for testing ranitidine because heating the sample generates NDMA,‘ the FDA said in its Oct. 2 statement.