"Common antibiotic dangerous, Canadian study shows"

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"Common antibiotic dangerous, Canadian study shows"

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First Posted: 02 Mar 2006 07:28 am

Common antibiotic dangerous, Canadian study shows


Globe & Mail - Wednesday, March 1, 2006

Canadian Press

Toronto — One of the most widely prescribed antibiotics in North America
appears to dramatically boost the risk of potentially life-threatening
blood sugar abnormalities, a large-scale study by Canadian researchers
has found.

The study found that the antibiotic gatifloxacin, sold under the brand
name Tequin by manufacturer Bristol-Myers Squibb, is associated with an
increased danger of both low blood sugar (hypoglycemia) and high blood
sugar (hyperglycemia), when compared with other antibiotics.

“What we found was that people taking gatifloxacin had more than a
fourfold increase in the risk of being treated in hospital for low blood
sugar than people who were on other antibiotics,” study co-author Dr.
David Juurlink said Wednesday.


“And the people on gatifloxacin had almost 17 times more risk of
developing high blood sugar,” said Dr. Juurlink, a senior researcher at
the Institute for Clinical Evaluative Sciences (ICES) in Toronto.

The research, released online Wednesday by the New England Journal of
Medicine, involved patients over age 65 admitted to hospital in Ontario.
While younger patients were not part of the study, Dr. Juurlink believes
they, too, could be adversely affected by the drug.

He warned that both low and high blood sugar, or glucose, can be fatal,
although plunging levels can cause death more quickly.

Symptoms of low blood sugar include sweating, shakiness, confusion,
light-headedness, a racing heart beat and trouble speaking. As the
levels drop further, a person may experience seizures, coma and
eventually death.

The hallmarks of high blood sugar include excessive urination and
thirst, confusion, and nausea. The condition can escalate to the point
of coma and death.

However, some people with abnormal blood sugar may experience no
symptoms at all.

If someone taking Tequin develops any of these symptoms, “they need to
seek medical attention urgently,” said Dr. Juurlink. Even those without
symptoms taking the drug should discuss with their physicians whether
their medication should be changed, he said.

Previous reports about the broad -spectrum antibiotic — commonly
prescribed for bacterial infections of the lungs, sinuses and urinary
tract — suggested it caused blood sugar abnormalities in diabetics, who
already have problems maintaining control of blood glucose.

But the ICES study found that the drug also adversely affected patients
without diabetes,” said Dr. Juurlink.

“And this is important because the recent warnings that have come forth
from regulators (Health Canada and the U.S. Federal Drug Administration)
and the company really have stressed the avoidance of this drug in
patients with diabetes.

“Our result simply is that this is a problem that can affect people who
do not have diabetes, as well.”

Health Canada, which recently issued two warnings about possible adverse
effects for diabetics taking gatifloxacin, plans to update safety
information on the drug's product labelling and is considering whether
that should include a “black box” warning, spokeswoman Jirina Vlk said
from Ottawa. A black box warning is used when a drug has potentially
lethal side-effects .

“The department is enhancing the warnings for non-diabetic patients as
well,” she said. “The issue here is to try to restrict the use to
mitigate the risk.”

Marc Osborne, a spokesman for Bristol-Myers Squibb in Canada, said the
company notified Health Canada in December about new safety information
on Tequin and informed Canadian doctors and pharmacists through special

Whether newer warnings would be issued for non-diabetics in light of the
ICES study's findings is something that would be decided in conjunction
with Health Canada, Mr. sborne said from Montreal.

“Tequin is generally well-tolerated in appropriate patients,” he said.

Gatifloxacin belongs to a class of antibiotics called fluoroquinolones,
the most prescribed antibiotics in North America. While one other drug
in the class, called levofloxacin, appeared to slightly increase the
risk of low blood sugar, Dr. Juurlink said the adverse effects on blood
glucose are not a “class effect.”

Still, he advised doctors to think twice before prescribing Tequin.

“I will never prescribe this drug,” he said. “These side-effects can
kill people. They are relatively common as side-effects go. They are
unpredictable and we've got plenty of alternative agents out there that
we could use instead.”

"Common antibiotic dangerous, Canadian study shows"
Globe & Mail - March 1, 2006
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