SILVER SPRING, Md.,
April 1, 2020 The U.S. Food and Drug
Administration today announced it is requesting manufacturers
withdraw all prescription and over-the-counter (OTC) ranitidine
drugs from the market immediately. This is the latest step in an
ongoing investigation of a contaminant known as
N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly
known by the brand name Zantac). The agency has determined that the
impurity in some ranitidine products increases over time and
when stored at higher than room temperatures and may result in
consumer exposure to unacceptable levels of this impurity. As a
result of this immediate market withdrawal request, ranitidine
products will not be available for new or existing prescriptions or
OTC use in the U.S.
"The FDA is committed to ensuring that the medicines
Americans take are safe and effective. We make every effort to
investigate potential health risks and provide our recommendations
to the public based on the best available science. We didn't
observe unacceptable levels of NDMA in many of the samples that we
tested. However, since we don't know how or for how long the
product might have been stored, we decided that it should not be
available to consumers and patients unless its quality can be
assured," said Janet
Woodcock, M.D., director of the FDA's Center for Drug
Evaluation and Research. "The FDA will continue our efforts
to ensure impurities in other drugs do not exceed acceptable limits
so that patients can continue taking medicines without
concern."
NDMA is a probable human carcinogen (a substance that could
cause cancer). In the summer of 2019, the FDA became aware of
independent laboratory testing that found NDMA in ranitidine. Low
levels of NDMA are commonly ingested in the diet, for example NDMA
is present in foods and in water. These low levels would not be
expected to lead to an increase in the risk of cancer. However,
sustained higher levels of exposure may increase the risk of cancer
in humans. The FDA conducted thorough laboratory tests and found
NDMA in ranitidine at low levels. At the time, the agency did not
have enough scientific evidence to recommend whether individuals
should continue or stop taking ranitidine medicines, and continued
its investigation and warned the public in September 2019 of the potential risks and to
consider alternative OTC and prescription treatments.
New FDA testing and evaluation prompted by information from
third-party laboratories confirmed that NDMA levels increase in
ranitidine even under normal storage conditions, and NDMA has been
found to increase significantly in samples stored at higher
temperatures, including temperatures the product may be exposed to
during distribution and handling by consumers. The testing also
showed that the older a ranitidine product is, or the longer the
length of time since it was manufactured, the greater the level of
NDMA. These conditions may raise the level of NDMA in the
ranitidine product above the acceptable daily intake limit.
With today's announcement, the FDA is sending letters to all
manufacturers of ranitidine requesting they withdraw their products
from the market. The FDA is also advising consumers taking OTC
ranitidine to stop taking any tablets or liquid they currently
have, dispose of them properly and not buy more; for those who wish
to continue treating their condition, they should consider using
other approved OTC products. Patients taking prescription
ranitidine should speak with their health care professional about
other treatment options before stopping the medicine, as there are
multiple drugs approved for the same or similar uses as ranitidine
that do not carry the same risks from NDMA. To date, the FDA's
testing has not found NDMA in famotidine (Pepcid), cimetidine
(Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or
omeprazole (Prilosec).
In light of the current COVID-19 pandemic, the FDA recommends
patients and consumers not take their medicines to a drug take-back
location but follow the specific disposal instructions in
the medication guide or package
insert or follow the agency's recommended steps, which
include ways to safely dispose of these medications at home.
The FDA continues its ongoing review, surveillance, compliance
and pharmaceutical quality efforts across every product area, and
will continue to work with drug manufacturers to ensure safe,
effective and high-quality drugs for the American public.
The FDA encourages health care professionals and patients to
report adverse reactions or quality problems with any human drugs
to the agency's MedWatch Adverse Event Reporting program:
- Complete and submit the report online at
www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at
1-800-FDA-0178.
Additional Resources:
- Questions and Answers: NDMA impurities in ranitidine (commonly
known as Zantac)
- What to Know and Do About Possible Nitrosamines in Your
Medication
- Information about Nitrosamine Impurities in Medications
Media Contact: Sarah Peddicord,
Sarah.Peddicord@fda.hhs.gov, 301-796-2805
Consumer Inquiries: Consumer Email, 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration