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The approval of gatifloxacin(TEQUIN) in October 2001 brought to nine the number of fluoroquinolone antibiotics on the market, and this drug joins sparfloxacin (ZAGAM) and moxifloxacin (AVELOX) as fluoroquinolones that can cause a dangerous abnormality in the heart’s electrical conduction known as QT prolongation that can lead to fatal heart rhythm disturbances such as torsade de pointes.
The European Agency for the Evaluation of Medicinal Products in a press release dated April 26, 2002,...
The approval of gatifloxacin(TEQUIN) in October 2001 brought to nine the number of fluoroquinolone antibiotics on the market, and this drug joins sparfloxacin (ZAGAM) and moxifloxacin (AVELOX) as fluoroquinolones that can cause a dangerous abnormality in the heart’s electrical conduction known as QT prolongation that can lead to fatal heart rhythm disturbances such as torsade de pointes.
The European Agency for the Evaluation of Medicinal Products in a press release dated April 26, 2002, indicated that a review of gatifloxacin “...was initiated because of safety and efficacy concerns.” The exact nature of these concerns was not revealed, but may involve the drug’s association with QT prolongation.
The QT interval is the length of time it takes the ventricles (large chambers of the heart) to discharge and recharge electrically. Prolongation of the QT interval can lead to disturbances (called cardiac arrhythmias) such as torsade de pointes. The QTc interval is measured on an electrocardiogram (EKG or ECG) in milliseconds (msec). The subscript “c” indicates that the QT interval has been corrected for the patient’s heart rate. Torsade de pointes is a French phrase that means “twisted point;” it describes the appearance of this type of rhythm disturbance on the EKG tracing.
The professional product labeling, or “package insert,” for gatifloxacin carries the bold-face warning in the box below:
WARNINGS THE SAFETY AND EFFECTIVENESS OF GATIFLOXACIN IN PEDIATRIC PATIENTS, ADOLESCENTS (LESS THAN 18 YEARS OF AGE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. GATIFLOXACIN MAY HAVE THE POTENTIAL TO PROLONG THE QTc INTERVAL OF THE ELECTROCARDIOGRAM IN SOME PATIENTS. DUE TO THE LACK OF CLINICAL EXPERIENCE, GATIFLOXACIN SHOULD BE AVOIDED IN PATIENTS WITH KNOWN PROLONGATION OF THE QTc INTERVAL, PATIENTS WITH UNCORRECTED HYPOKALEMIA (low blood potasium levels), AND PATIENTS RECEIVING CLASS 1A 9E.G., QUINIDINE, PROCAINAMIDE) OR CLASS III 9E.G., AMIODARONE, SOTALOL) ANTIARRHYTHMIC AGENTS. Gatafloxacin must not be used together with certain drugs given to treat heart rhythm disturbances. These are: amiodarone (CORDARONE); bretylium; disopyramide (NORPACE); moricizine (ETHMOZINE); procainamide (PROCANBID); quinidine (QUINAGLUTE DURA-TABS, QUINIDEX); and sotalol (BETAPACE). |
The professional product labeling for gatifloxacin also warns that it has not been studied in combination with other drugs that prolong the QT interval and should be used with caution when given with drugs such as cisapride (PROPULSID), erythromycin (EES), antipsychotic drugs such as thioridazine (MELLARIL), and tricyclic antidepressants such as amitriptyline (ELAVIL) and imipramine (TOFRANIL). We do not think it is worth the risk of taking gatifloxacin together with these drugs when there are other antibiotics just as effective and safer.
The editors of a highly respected independent source of drug information written for doctors and pharmacists, The Medical Letter on Drugs and Therapeutics, concluded their review of gatifloxacin by saying it may be more:
...active than levofloxacin [LEVAQUIN in a test tube] against pneumococci, but there is no evidence of any clinical advantage over the older drug. It is too early to tell whether any of the unexpected serious adverse effects that have limited use of some fluoroquinolones will occur with these new agents.
All fluoroquinolone antibiotics can cause inflammation of tendons and sometimes their rupture, most commonly in the Achilles tendon that connects the back of the heel to the calf muscle. Tendon rupture can require surgical repair or may result in prolonged disability. Gatifloxacin or any fluoroquinolone antibiotic should be stopped immediately if unexpected tendinitis occurs, and your doctor should be contacted as soon as possible. The Health Research Group petitioned the Food and Drug Administration (FDA) in 1996 to require a tendinitis and tendon rupture warning in the labeling of all fluoroquinolone antibiotics, and, as a result, all these drugs now carry this warning.
What You Can Do
There is no medical reason for you to be taking gatifloxacin. There are numerous other, safer antibiotics approved to treat the same infections as this drug.
