GW withdraws Raxar on safety concerns

Glaxo Wellcome says that it has voluntarily withdrawn itsfluoroquinolone antibiotic Raxar (grepafloxacin) from more than 30 countries worldwide because of "emerging safety concerns."

Although more than 2.5 million prescriptions have been written for the drug since its launch in 1997, GW says that a small number of severe cardiovascular events have been observed among patients which led it to make the decision. "While the reported incidence of such cardiovascular events is infrequent, the company is no longer convinced that the benefits of Raxar outweigh the potential risk to patients, given the availability of alternative antibiotics," it said.

A spokesman for GW told the Marketletter that, while the firm was unable to know the true number of cardiovascular events, there had been two confirmed and one non-confirmed report of non-fatal torsade de pointes, as well as seven deaths for which GW has not been able to exclude a link to Raxar. Most of the patients affected had underlying conditions and were reasonably elderly. Raxar is indicated for the treatment of a range of infections including pneumonia, bronchitis and some sexually-transmitted diseases.