Study finds broader risks with antibiotic
Says more than diabetics affectedMar 2, 2006 | Bloomberg
Bristol-Myers Squibb Co.'s Tequin antibiotic can cause potentially fatal swings in blood sugar for a broad group of patients, according to a study that researchers say may lead some doctors to abandon the drug.
The report shows that the risks go beyond those outlined by the Food and Drug Administration last month, when New York-based Bristol-Myers warned doctors not to give the antibiotic to diabetic patients. The caution was issued after reports of deaths from changes in blood-sugar levels.
Regulators and the company ''should ask themselves whether the risks of this drug, which seem to be unique, are justifiable given the availability of so many alternative antibiotics that simply don't cause this problem," Dr. David N. Juurlink, an author of the study and a clinical pharmacologist at Sunnybrook and Women's College Health Sciences Center in Toronto, said in a telephone interview yesterday.
The study found an elevated risk of blood-sugar swings even in patients without diabetes. Tequin, approved for use in the United States in 1999, had $150 million in worldwide sales last year. The antibiotic is used to treat adults with lung, sinus, or urinary-tract infections and certain sexually transmitted diseases. The study will appear in the March 30 edition of the New England Journal of Medicine, which released the findings early online because of their importance.
The study of medical records for more than 1.4 million residents of Ontario ages 66 and older showed that patients taking Tequin had four times the risk of low blood sugar compared with similar patients taking other drugs to fight infection. Those on Tequin had almost 17 times the danger of high blood sugar than those taking other antibiotics, the study showed.
The study is consistent with a recent review that found some patients, including diabetics, the elderly, and those with kidney disease, have a higher risk of developing blood-sugar problems, Eric Miller, a spokesman for Bristol-Myers, said in a telephone interview. The company's decision to change the label and advise doctors not to prescribe Tequin to diabetic patients was appropriate, he said.
Most of the patients who developed low blood sugar and two-thirds of those with high blood sugar were also being treated for diabetes.