* GSK recalls Zantac products in all markets as a
"precaution"
* Four products recalled; OTC ones not affected -UK
regulator
* GSK says working with regulators to address concerns
(Tweaks headline, first paragraph; adds company comment)
By Justin George Varghese
Oct 8 (Reuters) - GlaxoSmithKline on Tuesday said it
is recalling the popular heartburn medicine Zantac in all
markets as a "precaution", days after the U.S. Food and Drug
Administration found "unacceptable" levels of probable
cancer-causing impurity in the drug.
Zantac, also sold generically as ranitidine, is the latest
drug in which cancer-causing impurities have been found.
Regulators have been recalling some blood pressure and heart
failure medicines since last year.
Britain's medicines watchdog said GlaxoSmithKline (GSK) was
recalling four prescription-only Zantac medicines: a syrup, an
injection and tablets of 150 and 300 milligram (mg) dosages. (https://bit.ly/2IATooO)
Over-the-counter 75 mg dosage Zantac products are produced
by a different company and are not affected by the recall, it
added.
"GSK informed the MHRA of our decision to suspend the
release, distribution and supply of all dose forms of Zantac
products," a company spokesman confirmed to Reuters.
"GSK is continuing with investigations into the potential
source of the NDMA," he said, adding that the investigations
include continued engagement with its suppliers and with
external laboratories to conduct tests on finished product
batches of Zantac.
The Medicines and Healthcare products Regulatory Agency
(MHRA) said healthcare professionals were told on Monday to
"stop supplying the products immediately, quarantine all
remaining stock and return it to their supplier".
"We are advising that patients should not to stop taking
their medication, and do not need to see their doctor until
their next routine appointment but should seek their doctor's
advice if they have any concerns," the MHRA said.
GLOBAL STOPPAGE
U.S. and European health regulators said last month they
were reviewing the safety of ranitidine, after online pharmacy
Valisure flagged the impurities.
The FDA said Valisure's higher-temperature testing method
generated very high levels of NDMA from the ranitidine drugs.
NDMA had previously been found in some blood pressure
medicines from a class of drugs known as angiotensin II receptor
blockers, or ARBs.
After checking the over-the-counter drugs using a low-heat
method of testing, the FDA said it found much lower levels of
NDMA than was discovered with a higher temperature test employed
by Valisure.
The U.S. regulator has asked ranitidine makers to conduct
their own testing to assess levels of the impurity and to send
samples of their products for testing by the agency.
Swiss drugmaker Novartis halted global distribution
of its ranitidine drugs last month.
Last week, Walmart Inc joined pharmacy chains CVS
Health Corp, Walgreens Boots Alliance Inc and
Rite Aid Corp in suspending the sale of over-the-counter
heartburn drugs containing ranitidine.
Canada's health authorities have asked makers of the drugs
to halt distribution as they gather more information. Last
month, regulators in Hong Kong pulled four products, while in
Ireland 13 products containing ranitidine were recalled.
The impurity was believed to have been introduced by changes
in the manufacturing process.
(Reporting by Justin George Varghese in Bengaluru; Editing by
Deepa Babington, Mark Potter and Dan Grebler)
Glaxosmithkline (GSK)