CVS Stops Selling Zantac Products
September 29 2019 - 5:40PM
Dow Jones News
By George Stahl and Thomas M. Burton
CVS Health Corp. has stopped selling Zantac products at its
drugstores, citing a recent alert by the U.S. Food and Drug
Administration that the popular heartburn drug could contain low
levels of a probable human carcinogen.
CVS said Saturday that it is taking the action "out of an
abundance of caution." There is no recall of the product, but
customers who purchased these products at CVS can return them for a
refund.
Zantac is sold by Sanofi and generically under the name
ranitidine. A Sanofi spokesman said Sunday that the company is
working closely with the FDA and conducting its own investigations.
The company has no plans to stop distributing or manufacturing
Zantac or other ranitidine products, he said.
The FDA has said the chemical, known as NDMA, could cause harm
in large amounts; however, the levels it is finding in preliminary
tests of Zantac "barely exceed amounts you might expect to find in
common foods." The chemical is part of a class of compounds called
nitrosamines that are found in water and in foods like meats, dairy
products and vegetables.
The agency has said it is evaluating whether low amounts of the
chemical pose a risk to patients, and that it would make that
assessment available publicly as soon as possible. The FDA isn't
recommending individuals stop taking ranitidine medicines at this
time.
Last week, the FDA announced a voluntary recall of
over-the-counter ranitidine tablets, labeled by Walgreens, Walmart
and Rite-Aid. Novartis AG's Sandoz generic-drugs business also
voluntarily recalled its ranitidine products. Sandoz said it hasn't
received any reports of adverse events related to use of the
product.
Ranitidine, originally thought of as an ulcer drug, is approved
for treatment and prevention of ulcers in the stomach and
intestines as well as for heartburn. Sanofi has said that Zantac
has been around for over a decade and meets all the specified
safety requirements for use in the over-the-counter market.
Ranitidine is considered an H2 blocker, which reduces stomach
acid by blocking acids that produce it. CVS said its pharmacy will
continue to sell other over-the-counter H2 blockers, including
Pepcid, Tagamet and its respective generic equivalents, famotidine
and cimetidine.
Many generic drugs for high blood pressure have been found to be
contaminated by low levels of NDMA and related carcinogenic
chemicals. The FDA has grappled with NDMA for more than a year,
principally in generic drugs. The agency has acknowledged that two
million or more people world-wide had been exposed to the chemical
in blood-pressure drugs. These included generic drugs like
valsartan, irbesartan and losartan.
Write to George Stahl at george.stahl@wsj.com and Thomas M.
Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
September 29, 2019 17:25 ET (21:25 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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