Glaxo Wellcome announced on October 27 that it is withdrawing its oral quinolone antibiotic grepafloxacin (Raxar) from the market worldwide with immediate effect. The withdrawal, which is voluntary, is a result of "emerging safety concerns."
Glaxo Wellcome said that a small number of severe cardiovascular events have been noted in patients taking the drug. "The company is no longer convinced that the benefits of Raxar outweigh the potential risk to patients, given the availability of alternative antibiotics," the company said.
A spokesman for Glaxo Wellcome said that seven deaths, probably related to cardiac arrhythmias, had been reported where a causal relationship with Raxar could not be excluded. No UK deaths associated with the drug have been reported.
Grepafloxacin was marketed in over 30 countries. It was launched in the UK in January, 1998, for treatment of a variety of infections, including pneumonia and bronchitis. The company is writing to pharmacists and doctors about the withdrawal. Pharmacists will be asked to return stocks through the usual channels.
Grepafloxacin was licensed from Japanese company Otsuka. It was not a big product for Glaxo Wellcome, with estimated sales worldwide of £5m for the first half of this year.