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Tequin Diabetes


On February 15, 2006, Bristol-Myers Squibb sent out a Dear Doctor letter indicating that post market data indicated serious cases of hypoglycemia and hyperglycemia. Therefore, the Tequin label was revised to include a Contraindication in diabetic patients. Additionally, the Warnings and Precautions were updated to identify other risk factors for dysglycemia (older age, renal insufficiency and concomitant glucose-altering medications) while on Tequin along with a recommendation for close monitoring of patients in these classes. Further, the label now indicates that dysglycemic events may occur in patients with no history of diabetes.

What Is TequinTequin Recall


Following concerns of blood sugar problems, Information about the possible risk of low blood sugar and high blood sugar was added to Tequin's label in 2002. In February 2006, the manufacturer proposed additional warnings after receiving additional postmarketing reports of serious cases of hyperglycemia and hypoglycemia. According to a recent Canadian study Tequin users had 17 times greater risk of developing serious diabetes and 4 times greater risk of being hospitalized with low blood sugar complications than patients using other antibiotics. Some observers have noted that the proposed warning may not be enough given the findings of a soon to be published study, which found potentially fatal elevated risk of blood-sugar swings even in patients without diabetes. The study also found 69 deaths attributable to high or low blood sugar levels.

In the United States, Tequin (gatifloxacin) has already undergone four labeling changes on the basis of case reports suggesting that it can dramatically alter blood glucose levels. No large-scale studies have examined clinical outcomes related to the dysglycemic effects of outpatient gatifloxacin therapy. Using the health care records of more than 1.4 million Ontario residents 66 years of age or older, it was found that gatifloxacin was strongly associated with subsequent hospital care for hypoglycemia and for hyperglycemia, some life-threatening or fatal. With the exception of a slight increase in the risk of hypoglycemia with levofloxacin, these risks were not shared by other fluoroquinolones. Dysglycemic events were not restricted to patients receiving drug treatment for diabetes. The relative absence of dysglycemia in association with the other fluoroquinolone antibiotics is consistent with the findings of previous reports and analyses from postmarketing surveillance in the United States and Canada and is not suggestive of a class effect for the fluoroquinolones. Thus, Tequin offers relatively few therapeutic advantages over alternative antibiotics with little or no increased risk of dysglycemia


Tequin is an antibiotic approved by the FDA in 1999. The antibiotic is typically used to treat adults with lung, sinus or urinary- tract infections and certain sexually transmitted diseases.

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