RNS Number : 7855V
11 August 2022
Issued: 11 August 2022, London UK
Statement: Zantac (ranitidine) litigation
-- FDA and EMA have concluded there is no evidence of a causal
association between ranitidine therapy and the development of
-- 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 U.S.
Zantac litigation , GSK plc (LSE/NYSE: GSK) today
issued the following statement regarding Zantac (ranitidine) and N-nitrosodimethylamine (NDMA).
There have been no material developments to what has been
GSK, independent cancer researchers, the U.S. Food & Drug
Administration, and the European Medicines Agency, have all
undertaken extensive reviews of available data and conducted
numerous investigations into this issue since 2019.
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 November 2019, the FDA determined that levels of NDMA in
ranitidine products are similar to levels in common foods like
grilled and smoked meats, and that it would conduct tests to fully
understand if ranitidine forms NDMA in the human body.
-- In September 2020, the EMA's comprehensive review of
epidemiological and post marketing data concluded there is "no
evidence of a causal association between ranitidine therapy and the
development of cancer in patients."
-- In June 2021, the FDA reported that its testing did not
support that ranitidine is converted to NDMA in a general, healthy
population, and after reviewing the epidemiological studies found
that "...no consistent signals emerged across studies, and studies
with comparison to active controls found no association between
ranitidine and overall or specific cancer risk."
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
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
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
-- 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 10(th) 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
-- Kumar et al. (2021): "[O]ur results . . . demonstrate that
the true gastric carcinogenic impact of NDMA containing
ranitidine in persons in the US with HP (H. pylori) is likely
minimal to nonexistent, providing reassurance to those who have
taken ranitidine . . . . In time-specific analyses, there was no
period in which ranitidine was associated with future GC [gastric
cancer], suggesting there is no discernable difference in
formulation of the medication over time." "There is no demonstrable
association between ranitidine use and future gastric cancer among
individuals with HP on long-term acid suppression."
-- 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
-- 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
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
In the MDL, plaintiffs were required to identify the types of
cancer that they wished to pursue and identified 10 different
types. In November 2021, plaintiffs withdrew from consideration
breast cancer and kidney cancer, reducing the number of types of
cancer from 10 to 8. In January 2022, the MDL plaintiffs withdrew
from consideration colorectal, prostate, and lung and will proceed
only as to the following five types of cancer: bladder, esophageal,
gastric, liver, and pancreatic, although plaintiffs in state courts
continue to pursue these claims.
On 6 February 2020, the US product liability litigation was
assigned MDL status in the Southern District of Florida. The Group
has filed several rounds of Motions to Dismiss in the MDL resulting
in the following position: 1) the Court ruled in favour of the
Group's motion on innovator liability; that issue is on appeal; 2)
the Court ruled in favour of Defendants with respect to the Third
Party Payor Class Action; Plaintiffs opted not to replead their
action and these issues are now on appeal; 3) the Court dismissed
RICO claims from the Economic Loss Class Action but allowed the
class to move forward on plaintiffs misbranding theory; and 4) the
Medical Monitoring and Economic Loss class actions are allowed to
move forward. Generics, retailers, and packagers have been
dismissed from the cases.
Outside the US, there are several class actions and in excess of
100 personal injury cases pending against GSK in Canada, along with
a class action in Israel. Among the state court cases naming GSK, a
trial in California is currently scheduled to begin 13 February
2023 and trials in Madison County, Illinois are to proceed on 22
August 2022 and February 2023.
Whilst GSK has served Haleon with notice of potential claims in
relation to possible liabilities connected to OTC Zantac under the
relevant indemnification provisions, contained in the documentation
relating to the formation of the Consumer Healthcare JV, it is not
possible, at this stage, to meaningfully assess whether the outcome
will result in a probable outflow, or to quantify or reliably
estimate what liability (if any) that Haleon may have to GSK under
the relevant indemnities.
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.
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
Media: Tim Foley +44 (0) 20 8047 (London)
Madeleine Breckon +44 (0) 20 8047 (London)
Kathleen Quinn +1 202 603 5003 (Washington DC)
Lyndsay Meyer +1 202 302 4595 (Washington DC)
Investor Relations: Nick Stone +44 (0) 7717 618834 (London)
James Dodwell +44 (0) 20 8047 (London)
Mick Readey +44 (0) 7990 339653 (London)
Josh Williams +44 (0) 7385 415719 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
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.
Registered in England & Wales:
980 Great West Road
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact email@example.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
(END) Dow Jones Newswires
August 12, 2022 02:00 ET (06:00 GMT)
Historical Stock Chart
From Sep 2022 to Oct 2022
Historical Stock Chart
From Oct 2021 to Oct 2022