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 The move is part of the FDA's broader push to investigate a range of
drugs for the presence of the carcinogen, known as N-nitrosodimethylamine
(NDMA), with heartburn drug Zantac being recalled this year for fear
it contained NDMA.
The FDA later added that levels of contamination in Zantac, also
known as ranitidine, "are similar to the levels you would expect to
be exposed to if you ate common foods like grilled or smoked meats."
European Union drugs watchdog EMA said it was asking companies to
test metformin medicines in the EU for NDMA, reacting to findings in
Singapore of NDMA impurity in some metformin products.
EMA said Singapore’s Health Sciences Authority (HSA) was recalling
three out of the 46 metformin products tested.
EMA described the risk so far as very low, urging patients to
continue taking their medication because the danger of not
adequately controlling diabetes was far higher.
The FDA said it would recommend recalls as appropriate.
The Canadian health regulator, in turn, said that it was not aware
of any metformin products in Canada containing NDMA above acceptable
limits, but was working closely with international regulatory
partners on its assessment of the issue.
It has also asked companies to test their products and is collecting
samples from them to conduct its own testing, it added.
Metformin is a standard medication during early stages of type 2
diabetes. It helps control high blood sugar and is marketed under a
number of brand names, including Fortamet and Glucophage.
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The FDA's investigation follows other countries' findings of low
levels of NDMA in metformin drugs there, the agency said.
Based on its information, the FDA added, NDMA in those drugs ranged
within naturally occurring levels in food and water.
"The FDA is investigating whether metformin in the U.S. market
contains NDMA, and whether it is above the acceptable daily intake
limit of 96 nanograms," said Janet Woodcock, director of the FDA's
Center for Drug Evaluation and Research.
The agency will "recommend recalls as appropriate if high levels of
NDMA are found," she added in the statement.
Such action could put treatment out of reach for some sufferers, one
expert said.
"If these reports are true, it could be a big blow to many millions
of people on this drug," said Ranit Mishori, a professor of family
medicine at Georgetown University.
"There are many other alternatives and other medication classes but
many of them have side effects, are more expensive and some of the
newest ones may not be covered by insurance."
(Additional reporting by Dania Nadeem, Anuron Kumar Mitra and
Bhargav Acharya in Bengaluru; Editing by Rashmi Aich and Emelia
Sithole-Matarise)
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