Sanofi-Aventis, the drug maker, said yesterday that it planned additional discussions with the Food and Drug Administration after an advisory panel to the agency said the company should not be allowed to continue marketing the antibiotic Ketek. Ketek is used in the treatment of acute bacterial worsening of bronchitis or acute bacterial sinusitis.
The F.D.A. advisory panel earlier supported continued sales of Ketek for treating pneumonia acquired outside a hospital. The drug has been under scrutiny after reports of liver failure, vision problems, and other possible side effects.
The panel of outside experts voted 16 to 3 to support continued sales of Ketek for treating pneumonia acquired outside of a hospital. But they voted 17 to 2 against allowing Sanofi to keep promoting the drug for acute bacterial worsening of bronchitis and acute bacterial sinusitis.
