Pfizer's one-day Zithromax course squeaks through FDA advisory panel

Despite concerns about the potential for overuse, the US Food and DrugAdministration's Anti-Infective Drugs Advisory Committee on November 7 gave its backing to two shorter courses of Pfizer's Zithromax (azithromycin) for acute otitis media, as mentioned briefly in the last issue of the Marketletter.

The panel voted six-to-four to approve a single dose of 30mg/kg and seven-to-three for a three-day regimen of 10mg/kg a day. If approved by the agency, the shorter duration of therapy is likely to be much more attractive to physicians and parents coping with children who have the often-painful middle-ear infections.

However, the lure of a more convenient dose could lead to overprescribing, cautioned panelists, who added that another concern is that in the Pfizer studies, Zithromax did not work as well in children under the age of two. While panelists agreed that this younger age group tends to have more difficult-to-treat infections, they noted that there is a higher incidence in this population. That led some to vote against approval, saying they wanted to see pharmacokinetic or pharmacodynamic data, especially in those younger children.