Tequin Labeling Changes Reflect Continuing Reports of Dysglycemia

Yael Waknine

Disclosures

February 17, 2006

Feb. 17, 2006 — The US Food and Drug Administration (FDA) and Bristol-Myers Squibb Company have notified healthcare professionals via letter regarding safety labeling changes for gatifloxacin ( Tequin tablets and injection), according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

The changes reflect continuing reports of hypo- and hyperglycemia in patients receiving gatifloxacin therapy and include a contraindication for use in diabetic patients; a strengthened warning regarding the risk for these events; and information regarding related risk factors such as advanced age, renal insufficiency, and concomitant use of glucose-altering medications.

Since the approval of gatifloxacin in 1999, rare cases of life-threatening events have been reported globally in patients receiving the drug. Although appropriate treatment reversed the condition in most patients, a few had fatal outcomes.

According to the FDA, the agency will continue monitoring the safety of gatifloxacin to ensure that its benefits outweigh risks to patients.

Gatifloxacin is used for the treatment of infections due to susceptible strains of designated microorganisms. Specific indications include acute bacterial exacerbation of chronic bronchitis; acute sinusitis, community-acquired pneumonia, uncomplicated skin/skin structure infections, uncomplicated/complicated urinary tract infections, pyelonephritis, uncomplicated urethral/cervical gonorrhea, and uncomplicated rectal infections in women.

Adverse events related to use of gatifloxacin should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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