The Bristol Myers Squibb Co. antibiotic Tequin can have “life threatening” side effects including low blood sugar, according to a Canadian study Wednesday.
Elderly people who took Tequin were 17 times more likely to develop high blood sugar 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 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.
