Diabetics warned against using antibiotic drug Tequin

Feb 16 2006

The Food and Drug Administration in the U.S. have issued strong warnings concerning the use of the antibiotic drug Tequin.

The antibiotic is used for the treatment of patients with pneumonia, bronchitis, gonorrhea, and various infections including infections of urinary tract, kidneys, and skin.

The labeling changes have resulted from continued reports of serious cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients receiving Tequin.

Since it's approval in 1999, Tequin has been associated with globally reported, though rare, cases of life-threatening events in patients treated with the drug.

Although most of these events were reversible when properly managed, a few apparently died.

The label changes are particularly relevant to diabetic patients, and though warnings about the risks of low blood sugar and high blood sugar were added to the labeling in 2002, the new changes strengthen the existing ones and carry an added contraindication for use in diabetic patients.

The new information identifies other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose altering medications while taking Tequin.

The FDA says it will continue monitoring Tequin's safety to ensure that its benefits outweigh the risks to patients.

Tequin manufacturer Bristol-Myers Squibb Co. has informed healthcare professionals of the labeling changes for Tequin and has updated the prescription information.