GSK continued to manufacturer brand name prescription Zantac in the United States from 1997 to 2009 . French drug manufacturer Sanofi acquired the Zantac trademark in 2017 and continued to sell Zantac in the United States until it was recalled in 2019 . Each of these companies are named as defendants in various lawsuits across the country . From the time Zantac was put on the market , numerous studies have warned of ranitidine ’ s potential dangers ; specifically , that it facilitates NDMA production and cancer development . For example : a 1983 study sought to determine whether or not ranitidine reacted with nitrite in gastric environments ( such as the stomach ) to produce nitrosamines capable of producing any significant harmful effects . Glaxo ( GSK ) supplied the ranitidine for the study . After administering ranitidine and nitrites for five days , scientists observed “ DNA fragmentation ” in many of the rats ’ liver and mucus membrane of the stomach . DNA fragmentation is widely accepted in the scientific community as an initial step in developing cancer . Due to these concerning results , scientists warned that until they determine the effect ranitidine could have on humans , “ it could be wise to adopt …. simple measures to hinder the possible nitrosation of ranitidine .” One such “ simple measure ” was to warn consumers that they should “ not take [ ranitidine ] close to meals .”
Despite this information , GSK did not issue those , or any other warnings . Instead , over the years , the various manufacturers of Zantac encouraged customers to take Zantac simultaneous with or immediately following food . These companies aired hundreds of commercials depicting consumers eating the foods they love , experiencing heartburn , and taking Zantac for relief . Never once did any of these commercials warn consumers of the risk of developing cancer .
Over the next three decades , studies were continually published that warned of the dangers of ranitidine . In 2003 , one such study suggested that “ elevated levels of NDMA in drinking water produced by American wastewater treatment plants may be associated with the drug ranitidine .” In 2016 , a study conducted by Stanford University found that after ingesting a single 150 mg tablet of Zantac , patients excreted over 47,700 nanograms of NDMA in twentyfour hours , on average .
The Valisure Petition further brought these issues to light . During routine testing of ranitidine products , the pharmacy detected “ concerning levels of NDMA in ranitidine medications ” and alerted the FDA in June of 2019 . The FDA did not issue a warning or a recall . Due to the FDA ’ s failure to take action , Valisure filed a citizen ’ s petition to the FDA in September 2019 , alleging that it found “ extremely high levels of [ NDMA ] … in every lot tested , across multiple manufacturers and dosage forms of the drug ranitidine .” While the FDA and various defendants contend Valisure ’ s testing did not produce the most accurate measure of NDMA contained in each pill , the FDA issued a statement which conceded that the levels of NDMA present in Zantac are “ unacceptable .”
Shortly after the Valisure petition was released to the public , many companies began recalling ranitidine products . Prior to this recall , none of the defendants even attempted to warn consumers about cancer risks or NDMA contamination associated with their product .
HOW THE PRESENCE OF NDMA OCCURS
There are two main theories as to how ranitidine causes NDMA exposure : ( 1 ) ranitidine ’ s inherent instability results in NDMA formation as the pill is exposed to heat ; and ( 2 ) ranitidine combined with a high nitrite diet results in high of amounts of NDMA production .
The ranitidine molecule “ contains both a nitrite and a dimethylamine (“ DMA ”) group which are well known to combine to form NDMA .” This is likely due to the inherent stability of the ranitidine molecule . Numerous studies suggest that in such warm environments , “ ranitidine can react with itself to produce NDMA at levels well in excess of the permissible daily intake limit ” of 96 nanograms per day . These studies also demonstrate that “ NDMA [ resulting from ranitidine ’ s instability ] occurs in the conditions representative of those in the human body .” This evidence “ builds a compelling case for ranitidine being a likely human carcinogen .”
It is also possible that ranitidine is breaking down into NDMA after exposure to heat and humidity outside the body , such as in shipping and storage conditions . Emery Pharma , an independent laboratory , found that after exposing ranitidine to heat over 70 degrees Celsius ( 158 degrees Fahrenheit ) for just five days , the pill contained 142 nanograms of NDMA . This finding is significant , as is certainly possible for ranitidine to reach these temperatures during transportation from the manufacturer to the distributor , while in storage , or if left in a hot car after it has been purchased . Regarding these findings ,
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