Stronger FDA Warnings for Tequin
February 16, 2006
Today, Bristol-Myers Squibb Co. announced labeling changes for Tequin (gatifloxacin),
an antibiotic indicated for the treatment of patients with pneumonia, bronchitis,
uncomplicated gonorrhea, and various infections including infections of urinary
tract, kidneys, and skin.
The labeling changes, announced by the Tequin manufacturer in a letter to healthcare
professionals, update the prescription information as a result of continued
reports of serious cases of hypoglycemia (low blood sugar) and hyperglycemia
(high blood sugar) in patients receiving Tequin. Since the approval of Tequin
in 1999, there have been rare cases of life-threatening events reported globally
in patients treated with the drug. Most of these events were reversible when
properly managed, but a few had fatal outcomes.
Information about the risks of low blood sugar and high blood sugar was added
to the warnings section of the U.S. labeling in 2002. Today's changes strengthen
the existing warning on hypoglycemia (low blood sugar) and hyperglycemia (high
blood sugar), add a Contraindication for use in diabetic patients, and include
information identifying 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 will continue monitoring Tequin's safety to ensure that its benefits
outweigh the risks to patients.
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