Antibiotic Tequin Withdrawn From Market By Bristol-Myers

Serious Blood-Sugar Problems Hurt Safety Profile and Sales

On April 27, 2006 Bristol-Myers Squibb Co. announced that it would stop selling Tequin (gatifloxacin), an antibiotic that has been associated with hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar), both of which are potentially fatal blood-sugar disorders.

In mid-February 2006 Bristol-Myers Squibb (BMS), the FDA, and Health Canada announced that the label, or package insert, for Tequin would be changed to include stronger warnings about these life-threatening blood-sugar problems. The February 2006 label revision also pointed out that Tequin should not be used by anyone with diabetes.

An article in the March 30, 2006 edition of the New England Journal of Medicine (NEJM) reported about a Canadian study which found patients using Tequin had 17 times the risk of hyperglycemia (high blood sugar) and four times the risk of hypoglycemia (low blood sugar) when compared to patients taking other antibiotics. On March 1, 2006 the NEJM had published online an early-release version of this article about the Canadian Tequin study as well as an editorial which encouraged BMS to either add a "black-box" warning or recall Tequin from the market due these serious blood-sugar problems.

Tequin was introduced to the U.S. market in 1999. Prior to its withdrawl, Tequin had been used to treat lung, sinus, skin, or urinary-tract infections, as well as certain sexually transmitted diseases.

Read more about Tequin on our Tequin Information Page >>