statement alerting patients and health care
professionals of NDMA found in samples of ranitidin
For Immediate Release:
September 13, 2019
Director - Center for
Drug Evaluation and Research
Janet Woodcock M.D.
The U.S. Food and Drug Administration has
learned that some ranitidine medicines, including some products commonly known
as the brand-name drug Zantac, contain a nitrosamine impurity called
N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable
human carcinogen (a substance that could cause cancer) based on results from
laboratory tests. NDMA is a known environmental contaminant and found in water
and foods, including meats, dairy products, and vegetables.
The FDA has been
investigating NDMA and other nitrosamine impurities in blood pressure and heart
failure medicines called Angiotensin II Receptor Blockers (ARBs) since last
year. In the case of ARBs, the FDA has recommended numerous recalls as it
discovered unacceptable levels of nitrosamines.
When the agency
identifies a problem, it takes appropriate action quickly to protect patients.
The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk
to patients. FDA will post that information when it is available.
Patients should be able
to trust that their medicines are as safe as they can be and that the benefits
of taking them outweigh any risk to their health. Although NDMA may cause harm
in large amounts, the levels the FDA is finding in ranitidine from preliminary tests
barely exceed amounts you might expect to find in common foods.
Ranitidine is an
over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2)
blocker, which decreases the amount of acid created by the stomach.
Over-the-counter ranitidine is approved to prevent and relieve heartburn
associated with acid ingestion and sour stomach. Prescription ranitidine is
approved for multiple indications, including treatment and prevention of ulcers
of the stomach and intestines and treatment of gastroesophageal reflux disease.
The agency is working
with international regulators and industry partners to determine the source of
this impurity in ranitidine. The agency is examining levels of NDMA in
ranitidine and evaluating any possible risk to patients. The FDA will take
appropriate measures based on the results of the ongoing investigation. The
agency will provide more information as it becomes available.
The FDA is not calling
for individuals to stop taking ranitidine at this time; however, patients
taking prescription ranitidine who wish to discontinue use should talk to their
health care professional about other treatment options. People taking OTC
ranitidine could consider using other OTC medicines approved for their
condition. There are multiple drugs on the market that are approved for the
same or similar uses as ranitidine.
Consumers and health care
professionals should report any adverse reactions with ranitidine to the
FDA’s MedWatch program to help the agency better understand the
scope of the problem:
Complete and submit the
report online at www.fda.gov/medwatch/report.htm
Download and complete the
appropriate form, then submit it via fax at 1-800-FDA-0178
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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Comment from Dr. Tierce:
This is about as official a statement as I could find on the Zantac concerns.
I am switching those with concerns to Famotidine or Tagamet. The statement notes that the recommendation is not to stop these medications, per se. thus, I don't feel strongly about seeking out our patients on a case by case basis to notify and change their meds