Bristol-Myers Squibb To Stop Selling Antibiotic Drug Tequin

BMS Action Follows Reports Of Serious Blood-Sugar Problems And Recent Warning Label Changes

An April 27, 2006 article by Peter Loftus for Dow Jones Newswires broke the news that Bristol-Myers Squibb Co. has decided to stop selling Tequin (gatifloxacin), an antibiotic that has been associated with potentially fatal blood-sugar problems.

As background, in mid-February 2006 Bristol-Myers Squibb (BMS), the FDA, and Health Canada announced that the package insert, or label, for Tequin would be changed to include stronger warnings about the threat of life-threatening events from blood-sugar changes.  The February 2006 label change also recommended that Tequin not be taken by diabetics, who must carefully control blood-sugar levels to avoid complications.

On March 1, 2006 the New England Journal of Medicine (NEJM) published online an early-release version of an editorial and an article alerting doctor about serious blood-sugar problems associated with Tequin. Specifically, the study reported in this March 2006 NEJM article found that patients using Tequin had four times the risk of hypoglycemia (low blood sugar) and a remarkable 17 times the risk of hyperglycemia (high blood sugar) when compared to other antibiotics.  These types of changes in blood sugar can induce coma and other serious medical problems, including death. 

Tequin was used to treat lung, sinus, skin, or urinary-tract infections, as well as certain sexually transmitted diseases. Tequin was approved by the FDA in 1999.

(Posted by: Tom Lamb)

Comments

[syed aaziz haider rizvi]

dear sir or madam

now what will FDA will do. either withdraw from international market or it will recalled . secondally Teva has also got tntative approval from FDA . waht will Teva will do now . will the product Gatifloxacin will be available in future or not . these are the questions in the mind of doctors and consumers. i think FDA medwatch has immediatelt respond to this publics safety issue. thanks . aaziz rizvi pakistan