WASHINGTON -An antibiotic plagued by serious blood-sugar complications is being pulled by its manufacturer from the U.S. and Canadian markets.
Bristol-Myers Squibb Co. confirmed Monday that it plans to stop making and selling Tequin, known generically as gatifloxacin. The company will return rights to the drug to Japan's Kyorin Pharmaceutical Co., said Bristol-Myers Squibb spokesman Eric Miller, noting that the decision was made after a commercial evaluation of the product as well as an ongoing transition in the company's focus.
Health Canada has been advised that Tequin will no longer be sold to Canadian pharmacies, Chris Williams, a spokesman for the federal department, said Monday from Ottawa.
Approved for sale in 1999, Tequin has faced questions about its effects on blood sugar: it has been associated with both high-and low-blood sugar in some patients.
Two months ago, a Canadian study found that Tequin was linked to a fourfold increase in the risk of being treated in hospital for low blood sugar and an almost 17-times greater risk of developing high blood sugar. The study of patients over age 65 was published in the New England Journal of Medicine.
Earlier this year, the U.S. Food and Drug Administration required increased warnings on the drug's label. Health Canada also issued warnings about possible adverse effects for diabetics taking Tequin and had planned to further update safety information, including the possibility of a "black box" warning used when a drug is potentially lethal.
Bristol-Myers Squibb had warned that the drug should not be used by diabetics and said the elderly and those with kidney disease were more likely to have problems.
While the company will stop making and selling Tequin, stocks currently available are not being recalled, said Miller, who advised people taking Tequin not to discontinue the drug until they talk with their physicians about an alternative.
Tequin is prescribed for chronic bronchitis, sinusitis, pneumonia, urinary tract and other infections.
Meanwhile, a U.S. public interest group petitioned the FDA on Monday for a ban on the antibiotic. Public Citizen urged the FDA to order a recall of Tequin.
In its petition, Public Citizen said there have been 388 patients with blood-sugar irregularities associated with the drug, including 20 deaths and 159 hospitalizations, since Jan. 1, 2000.
"This drug carries unique risk but has no unique benefits and therefore should not be on the market," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
Tequin had $150 million US in global sales last year.
Bristol-Myers shares fell 38 cents, or 1.5 per cent, to close at $25 on the New York Stock Exchange.
