U.S. Food and Drug Administation
DISCLAIMER: FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.
November 1, 1999
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Glaxo Wellcome has voluntarily withdrawn all licensed formulations of RAXAR and the product is no longer available from pharmacies.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.
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 damaged samples.
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).
Richard S. Kent, MD
Vice President - US Medical Operations
Glaxo Wellcome Inc.
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