FDA Finds Probable Carcinogen in Some Versions of Zantac --Update
By Thomas M. Burton
WASHINGTON -- The Food and Drug Administration said it has
learned of a probable human carcinogen found at low levels in some
versions of the popular heartburn drug Zantac, sold over the
counter and in various generic forms.
The FDA said it is evaluating whether the low amounts of the
chemical, known as NDMA, pose a risk to patients. It said it would
make that assessment available publicly as soon as it can.
Zantac is sold by Sanofi and generically under the name
ranitidine. The agency said that while "NDMA may cause harm in
large amounts," the levels it is finding in preliminary tests
"barely exceed amounts you might expect to find in common
The chemical is part of a class of compounds called nitrosamines
that are found in water and in foods like meats, dairy products and
The FDA acted after an online pharmacy called Valisure LLC, of
New Haven, Conn., turned up the contamination in testing the
quality of batches of medications that it sells.
Ranitidine, originally thought of as an ulcer drug, now is
approved both for treatment and prevention of stomach ulcers and
those of the intestines, as well as for gastroesophageal reflux
disease, or heartburn.
A range of generic drugs for high blood pressure already had
been found to be contaminated by low levels of NDMA and related
carcinogenic chemicals. The FDA has been grappling with this issue
for more than a year, principally in generic drugs including
valsartan manufactured in China and India.
The FDA said it couldn't immediately say whether any of the
generic Zantac products were made in China or India.
"Sanofi takes patient safety seriously, and we are committed to
working with the FDA," Sanofi said. "Zantac OTC (over the counter)
has been around for over a decade and meets all the specified
safety requirements for use in the OTC market."
The FDA has previously acknowledged that two million or more
people world-wide had already been exposed to the chemical in blood
pressure drugs. These included generic drugs like valsartan,
irbesartan and losartan.
Over the past year, there have been a series of recalls of
various lots of those hypertension drugs made by various companies,
largely from raw material facilities both in China and India. The
contamination, while small, has raised questions about the safety
of generic drugs, many of which come from raw materials in those
Not all generic blood-pressure products are affected.
So far, the FDA has said about the blood-pressure drugs that the
impurities in question resulted inadvertently from a manufacturing
process. It has said that, regarding the issue with the
blood-pressure drug valsartan, there may be one additional case of
cancer among 8,000 people if they took the highest dose of the drug
constantly for four years.
Valisure, in a filing this week with the FDA known as a
citizen's petition, said its analysis "reveals the ability of the
ranitidine molecule to form NDMA" in conditions like those in the
human body, perhaps suggesting a phenomenon different from that
involving the blood-pressure medicines.
Write to Thomas M. Burton at firstname.lastname@example.org
(END) Dow Jones Newswires
September 13, 2019 16:11 ET (20:11 GMT)
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