Grepafloxacin
Encyclopedia
Grepafloxacin hydrochloride (trade name Raxar, Glaxo Wellcome) was a oral broad-spectrum quinoline
antibacterial agent used to treat bacteria
l infection
s. Grepafloxacin was withdrawn world wide from markets owing to its side effect of lengthening the QT interval
on the electrocardiogram
, leading to cardiac events and sudden death
.
GlaxoSmithKline marketed Raxar at doses of 200 milligrams, 400 milligrams and 600 milligrams. Records filed with the U.S. Food and Drug Administration (FDA) showed that Raxar was cited as a suspect in the reported deaths of 13 patients. There were four deaths associated with patients who took Raxar in 600-milligram doses within the clinical trials submitted with the New Drug Application (NDA) in 1997. The package insert approved by the FDA stated that "there were no deaths or permanent disabilities" among those who took Raxar in 400-milligram doses. It was the FDA’s position that none of the noted fatalities "was shown to be attributable to Raxar." On Oct. 27, 1999, GlaxoSmithKline removed Raxar from clinical use citing to the fact that Raxar's effect on "QT interval prolongation" was unacceptably risky.
Other drugs within this class (i.e. sparfloxacin, moxifloxacin, levofloxacin, gatifloxacin, gemifloxacin) have also been associated with QT interval prolongation, resulting in sudden death of the patient.
Quinoline
Quinoline is a heterocyclic aromatic organic compound. It has the formula C9H7N and is a colourless hygroscopic liquid with a strong odour. Aged samples, if exposed to light, become yellow and later brown...
antibacterial agent used to treat bacteria
Bacteria
Bacteria are a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria have a wide range of shapes, ranging from spheres to rods and spirals...
l infection
Infection
An infection is the colonization of a host organism by parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease...
s. Grepafloxacin was withdrawn world wide from markets owing to its side effect of lengthening the QT interval
QT interval
In cardiology, the QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the QT interval represents electrical depolarization and repolarization of the left and right ventricles...
on the electrocardiogram
Electrocardiogram
Electrocardiography is a transthoracic interpretation of the electrical activity of the heart over a period of time, as detected by electrodes attached to the outer surface of the skin and recorded by a device external to the body...
, leading to cardiac events and sudden death
Sudden death
In a sport or game, sudden death is a form of competition where play ends as soon as one competitor is ahead of the others, with that competitor becoming the winner. Sudden death is typically used as a tiebreaker when a contest is tied at the end of the normal playing time or the completion of...
.
GlaxoSmithKline marketed Raxar at doses of 200 milligrams, 400 milligrams and 600 milligrams. Records filed with the U.S. Food and Drug Administration (FDA) showed that Raxar was cited as a suspect in the reported deaths of 13 patients. There were four deaths associated with patients who took Raxar in 600-milligram doses within the clinical trials submitted with the New Drug Application (NDA) in 1997. The package insert approved by the FDA stated that "there were no deaths or permanent disabilities" among those who took Raxar in 400-milligram doses. It was the FDA’s position that none of the noted fatalities "was shown to be attributable to Raxar." On Oct. 27, 1999, GlaxoSmithKline removed Raxar from clinical use citing to the fact that Raxar's effect on "QT interval prolongation" was unacceptably risky.
Other drugs within this class (i.e. sparfloxacin, moxifloxacin, levofloxacin, gatifloxacin, gemifloxacin) have also been associated with QT interval prolongation, resulting in sudden death of the patient.