The U.S. Department of Justice (DOJ) has opened an investigation into whether drugmakers hid data about the presence of a probable carcinogen in Zantac (ranitidine).
Sanofi and GlaxoSmithKline (GSK) said in separate U.S. Securities and Exchange Commission filings in July that they received civil investigative demands from the DOJ looking for information related to the heartburn drug.
The news of the investigation comes after global recalls, as well as an FDA ban. The FDA ban came after tests showed N-nitrosodimethylamine (NDMA) levels in the drug could increase over time due to heat. NDMA is classified by the U.S. Environmental Protection Agency (EPA) as a probable human carcinogen.
The DOJ is investigating whether the drugmakers violated the False Claims Act by failing to tell healthcare providers or the public that medications containing ranitidine could contain NDMA.
Ranitidine experiment results were published in 1981 by Dr. Silvio de Flora of the University of Genoa. These results showed that “toxic and mutagenic effects” happened when ranitidine was exposed to nitrates and human gastric fluid. Dr. de Flora said the reason for these effects might have been “formation of more than one nitroso derivative [which includes NDMA] under our experimental conditions.”
Two weeks later, The Lancet contained a response to these experiment results from GSK, demonstrating GSK’s awareness of the results.
It has been known since at least 1979 that NDMA is a probable carcinogen. A news article in that year read, “NDMA has caused cancer in nearly every laboratory animal tested so far.” The only modern use for NDMA is intentionally giving cancer to lab animals for cancer research purposes.
NDMA has been found to be carcinogenic in many different animals, including newts, frogs, ducks, fish, pigs, mastomys, rabbits, guinea pigs, hamsters, mice and rats. The World Health Organization (WHO) claims the presence of “conclusive evidence that NDMA is a potent carcinogen,” adding that there is “clear evidence of carcinogenicity.”
By 1987, multiple studies demonstrated evidence that ranitidine had a problem with carcinogenic nitroso compounds. A lawsuit claims GSK responded to this evidence with a “rigged” study that found patients who took ranitidine didn’t have any NDMA in their gastric contents. The lawsuit says an inaccurate analytical system was used in this study, and that all gastric samples with ranitidine in them were removed from the study.
“Without the chemical being present in any sample, any degradation into NDMA could not, by design, be observed,” the lawsuit claims.