Substantial scientific evidence supports FDA/EMA conclusion.
Plaintiff litigation inconsistent with the scientific consensus, GSK will vigorously defend all claims.
In response to recent speculative commentary regarding
There have been no material developments to what has been previously disclosed.
GSK, independent cancer researchers, the
Based on these investigations and experiments, GSK, the FDA, and the EMA have all independently concluded that there is no evidence of a causal association between ranitidine therapy and the development of cancer in patients.
In
In
In
These conclusions pertain to all forms of cancer, including but not limited to bladder, breast, colorectal, esophageal, kidney, liver, lung, pancreatic, prostate, and stomach. Even epidemiologic experts hired by the Multi-District Litigation (MDL) Plaintiffs' Steering Committee concluded in their expert reports that the 'evidence was not sufficient to support an opinion that use of ranitidine can cause breast, prostate, kidney, lung, or colorectal cancer.'
Since the issue concerning the presence of NDMA in ranitidine arose in 2019, the scientific community has actively focused on understanding whether there is a link between ranitidine and cancer. There have been 11 epidemiological studies conducted in that time looking at human data regarding the use of ranitidine.
The resulting scientific consensus is that the totality of the reliable evidence does not support that ranitidine increases the risk of any type of cancer:
Adami et al. (2021): 'If a causal association existed, we would expect to observe stronger associations with a larger number of prescriptions and, most likely, with longer follow-up, yet such patterns were not evident.' 'Our results, which do not support any carcinogenic effect on esophagus, stomach, liver or pancreas, should be reassuring for millions of concerned past users of ranitidine.'
Cardwell et al. (2021): '[T]here was little evidence of difference in bladder cancer risk when directly comparing ranitidine users with users of non-ranitidine histamine-2 receptor agonists,' but '...the use of ranitidine particularly long term use was associated with an increased risk of bladder cancer [compared to non-use or PPIs].' Further studies are necessary to attempt to replicate this finding.
Norgaard et al. (2021): Compared to H2RAs and compared to PPIs, 'we did not observe any consistent or substantial increase in risks of bladder cancer and we consistently across sub-analyses observed no increased risk [of] kidney cancer in ranitidine users,' and 'we found no dose-response association [with bladder cancer] when restricting to persons who redeemed at least five and persons who redeemed at least 10 prescriptions,' and 'starting follow-up time 10 years after the 10th prescription did not suggest any associations [with bladder cancer].'
Iwagami et al. (2021): '...we found no evidence of an increased risk of cancer in people receiving ranitidine and nizatidine compared with people receiving other H2 blockers overall, by follow-up length, by cumulative dose, or by cancer site. These results may alleviate concerns of patients exposed to ranitidine/nizatidine, although further research with longer follow-up and including older people may be needed.'
Kantor et al. (2021): 'Ranitidine use was not associated with overall cancer risk . . . [or] with risk of common cancers (lung, breast, prostate, and colorectum). . . . Compared to non-use, ranitidine use was positively associated with liver cancer; however, this association was attenuated when directly compared to omeprazole, which may reflect residual confounding by indication (or another jointly-related factor).'
Kim S. et al. (2021): 'We found no significant difference in terms of gastric cancer development among the three study groups (control, other histamine-2 blockers, and ranitidine), suggesting that the intake of ranitidine, even if it contains NDMA, may not be associated with an increased risk of developing gastric cancer.'
Liu et al. (2020): 'Our results revealed a marked increase in the prescription of acid-suppression medications immediately before gastric cancer diagnosis suggesting the role of reverse causation.'
Kim YD et al. (2021): 'Use of ranitidine was not associated with an increased odds of developing gastrointestinal malignancies compared to omeprazole or famotidine use.'
Yoon et al. (2021): 'We found no evidence that exposure to NDMA through ranitidine increases the risk of cancer.'
McDowell et al. (2021): 'Only two medicines were significantly associated with an increased risk of pancreatic cancer [metronidazole and ranitidine]. However, neither exhibited strong evidence of an exposure-response relationship with cancer risk.'
Litigation status
GSK has been named as a defendant in approximately 3,000 filed personal injury cases in federal and state court and numerous unfiled claims registered in a census established by the Court presiding over the Zantac Multidistrict Litigation (MDL) proceeding. Class actions alleging economic injury and a third-party payer class action also have been filed in federal court.
In the MDL, plaintiffs were required to identify the types of cancer that they wished to pursue and identified 10 different types. In
On
Outside the US, there are several class actions and in excess of 100 personal injury cases pending against GSK in
Whilst GSK has served
The overwhelming weight of the scientific evidence supports the conclusion that there is no increased cancer risk associated with the use of ranitidine. Suggestions to the contrary are therefore inconsistent with the science, and GSK will vigorously defend itself against all meritless claims alleging otherwise.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022 and any impacts of the COVID-19 pandemic.
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