FDA Orders Zantac, Similar Heartburn Medicines Off the Market
01 April 2020 - 7:06PM
Dow Jones News
By Maria Armental and Colin Kellaher
U.S. health regulators ordered that the popular heartburn drug
Zantac and other ranitidine generics be pulled from the market
immediately, citing a potential public-health risk.
The Food and Drug Administration had found elevated levels of a
possible cancer-causing chemical that led to voluntary recalls
starting last year, including by French health-care giant Sanofi
SA.
On Wednesday, the FDA said levels of the potential carcinogen in
some ranitidine products increases over time, even under normal
storage conditions, and that it was found to increase significantly
in samples stored at higher-than-room temperatures, including
temperatures the product may be exposed to during distribution and
handling by consumers.
The agency said that all prescription and over-the-counter
ranitidine products must be pulled off shelves and that consumers
stop taking the medications immediately and switch to approve
alternatives, following consultation with health-care
professionals.
"We didn't observe unacceptable levels of NDMA in many of the
samples that we tested," Dr. Janet Woodcock, director of the FDA's
Center for Drug Evaluation and Research said, referring to the
chemical N-Nitrosodimethylamine. "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."
The FDA said that testing at this point hasn't found NDMA in
famotidine, (brand name Pepcid), cimetidine (Tagamet), esomeprazole
(Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
Write to Maria Armental at maria.armental@wsj.com and Colin
Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
April 01, 2020 12:51 ET (16:51 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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