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Withdrawal of Product: Raxar

Dear Health Care Provider:

Glaxo Wellcome has voluntarily withdrawn all licensed formulations of RAXAR and the product is no longer available from pharmacies.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 the following diseases: community-acquired pneumonia; acute bacterial exacerbations of chronic bronchitis; uncomplicated gonorrhea (urethral in males and endocervical and rectal in females); non-gonococcal urethritis and cervicitis.

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 antibiotic therapy.


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