US group seeks ban on discontinued Bristol drug
Mon May 1, 2006 6:36pm ET
Health News
 
WASHINGTON (Reuters) - U.S. regulators should ban a Bristol-Myers Squibb Co. antibiotic because even though the company no longer makes the drug, which carries certain health risks, there are still supplies available, a consumer group said on Monday.

Bristol-Myers said on Friday it had ceased production of the antibiotic, Tequin, for economic reasons. The drug had sales of $150 million in 2005.

Public Citizen said the drug was riskier than other antibiotics and asked the Food and Drug Administration to outlaw it. Without a ban, patients could be prescribed the drug until supplies run out.

Tequin, known generically as gatifloxacin, is part of a class of antibiotics known as fluoroquinolones. The FDA approved it in 1999.



"Banning gatifloxacin will force clinicians to choose safer alternative fluoroquinolones or other antibiotics and will prevent product currently in the chain of commerce from unnecessarily injuring additional patients," the group said in a petition to the FDA.

A study published earlier this year in the New England Journal of Medicine said Tequin could have dangerous effects on blood sugar levels.

Public Citizen said its analysis of FDA records found 388 reports of dangerously high or low blood sugar in patients who took Tequin. Twenty of the patients died and 159 were admitted to a hospital.

Bristol-Myers spokesman Eric Miller said he did not know how much Tequin remained with pharmacies or suppliers, but he said the company was not planning to recall the doses.

Asked if the drug should be banned, Miller said: "I would leave that up to the FDA."



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