Bristol-Myers drug raises diabetes risk: study By Gene Emery
Wed Mar 1, 9:03 PM ET

BOSTON (Reuters) - The Bristol Myers Squibb Co. antibiotic Tequin can have
"life threatening" side effects including serious diabetes, according to a
Canadian study on Wednesday which urged doctors to stop prescribing it.

Elderly people who took Tequin were 17 times more likely to develop serious
diabetes than if they took another antibiotic, and were four times more
likely to be hospitalized for low blood sugar, the study found.

The study was to be published in The     New England Journal of Medicine on
March 30 but it was released early because of its important public health
implications, the journal said.

Whether the drug, also known by the generic name gatifloxacin, should be
pulled from the market "is a question for regulators and the company," said
author Dr. David Juurlink of the Sunnybrook and Women's College Health
Sciences Center in Toronto.

"But here you have a drug that produces life-threatening side effects" that
other antibiotics in the same class do not, Juurlink said in the study.

In a Journal editorial, Dr. Jerry Gurwitz of the Meyers Primary Care
Institute in Worcester, Mass., said the U.S.     Food and Drug
Administration should consider its most serious, "black box," warning for
the drug.

"For every approved indication for gatifloxacin, there are safer, equally
effective and less costly alternatives," Gurwitz said.

Compared to other drugs that have recently been pulled from the market
because of dangerous side effects, "this choice should not be a difficult
one for physicians, patients, regulators and manufacturers," Gurwitz said.

Tequin was introduced onto the market in 1999 but only generated $150
million in sales for Bristol-Myers in 2005, a fraction of the group's $19.2
billion total revenue, said company spokesman Eric Miller. Tequin's sales
totaled about $100 million in the United States.

Miller said that last month U.S. regulators authorized a change to the
drug's package insert which warned the drug should not be given to patients
with diabetes. He said that the company has also decided to stop actively
marketing the drug.

Juurlink told Reuters the blood-sugar problem "can happen to anybody"
whether they have diabetes or not, and it "typically appears within a day or
two of taking the drug."

It does not permanently damage the body's ability to control blood sugar.
However, it could be deadly if a person's blood sugar falls too low.

Because the two-year study only used hospital data, "somebody could easily
die from a seizure from low blood sugar and they would never have made it
into our study," Juurlink said.

Thus, the actual risk of the drug is probably greater than the study
revealed, he said. "We can't identify everybody, only those who survived to
go to the hospital or those sick enough to go to the hospital."

In their survey of 1.4 million records, the researchers also found that a
related drug, levofloxacin, also increased the risk of low blood sugar, but
only by 50 percent.

Other drugs in this class have had problems because of side effects.

Abbott Laboratories' temafloxacin was found to cause kidney failure and low
blood sugar. GlaxoSmithKline's Raxar (grepafloxacin) and Rhone-Poulenc
Rorer's Zagam (sparfloxacin) had been know to produce heart problems.
Trovafloxacin has been found to sometimes poison the liver.