FDA has concerns about expanding use of Gemifloxacin (FACTIVE)
Gemifloxacin (FACTIVE), proposed as a treatment for acute sinus infections, should be studied further due to serious skin reactions associated with its use according to FDA documents released on Sep 12, 2006.

Gemifloxacin (FACTIVE) for sinus infections is questioned

An FDA panel said Gemifloxacin (FACTIVE) is neither safe nor effective enough to treat acute sinus infections based on current data. FACTIVE is already approved to treat certain cases of pneumonia and bronchitis, and its maker is seeking FDA permission to expand the use of FACTIVE as a treatment of for bacterial sinusitis. The FDA has been concerned about a higher risk of skin rashes seen in clinical studies of FACTIVE since the drug was put on the market. While none of the skin rashes was life-threatening, FDA medical officers said they were concerned the rashes might indicate a risk for a high incidence of skin reactions if the drug were to be used more widely.

The FDA, which is expected to make its decision later this year, sought the advice of its outside experts on whether to approve the drug for sinusitis.

Source : http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4232B1-02-01-FDA-background.pdf