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Bristol-Myers Squibb announced its plans yesterday to take the antibiotic Tequin off the market.
Tequin, an antibiotic prescribed for chronic bronchitis, sinusitis, pneumonia, urinary tract and other infections, has been associated with serious blood-sugar complications in patients.
Public Citizen, a public interest group, petitioned the FDA on Monday for a ban on the antibiotic, citing 388 patients with blood-sugar irregularities linked to the drug including 20 deaths and 159 hospitalizations since early 2000.
“This drug carries unique risk but has no unique benefits and therefore should not be on the market,” argued Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.
The FDA approved the sale of Tequin in 1999, but in February 2006 required the drug to carry and increased warning on its label. The warning cautioned diabetics not to take the drug and mentioned a heightened risk for the elderly and those with kidney disease.
Spokesman for Bristol-Myers Squibb Eric Miller said the company will stop making and selling the drug but will not recall current stocks. People using Tequin should speak with a physician before discontinuing use of the drug, Miller urged.
The company plans to return the rights to the drug to Kyorin Pharmaceutical Company in Japan.
Last year, Tequin had $100 million in U.S. sales and $50 million more globally.
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