November 7, 1999
Letter To HealthCare Proffesionals
Announce the Withdrawal of RAXAR
Washington, DC (SafetyAlerts)
- In a recent letter to healthcare proffessionals, Richard S. Kent, MD, Vice President of
US Medical Operations for Glaxo Wellcome has announced the voluntarily withdrawal of all
licensed formulations of RAXAR and the product is no longer available from pharmacies.
RAXAR is a fluoroquinolone antibiotic indicated
for the treatment of infections caused by strains of bacteria susceptible to grepafloxacin
in community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis,
uncomplicated gonorrhea (urethral in males and endocervical and rectal in females) and
non-gonococcal urethritis and cervicitis.
According to the letter, Glaxo Wellcome has
recently concluded an extensive review of the safety of RAXAR and determined that due to
an effect of RAXAR on cardiac repolarization, manifested as QT interval prolongation on
the electrocardiogram (ECG), some patients may be at risk of a very rare but serious
ventricular arrhythmia known as torsade de pointes when treated with the product.
Although torsade de pointes has been reported very
rarely in patients taking RAXAR, it is considered by the Company that the therapeutic
benefit of treatment with RAXAR may be outweighed by the potential risk to patient safety,
especially given the availability of alternative treatments.
For patients already commenced on a course of
RAXAR, careful consideration should be given to switching the patient to an alternative
If you have any samples of RAXAR in your
possession, you may either contact Glaxo Wellcome to request self-addressed, postage-paid
boxes to facilitate returning samples to Glaxo Wellcome, or you may dispose of any
remaining RAXAR samples in the usual and customary way that you dispose of expired or
If you would like to request boxes, or for more
information, please contact the Glaxo Wellcome Customer Response Center at telephone
number 1-888-TALK-2-GW (888-825-5249).
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