Thursday, September 28, 2006

Sinus Antibiotic Causes Skin Rashes

The powerful antibiotic Factive (gemifloxacin) may cause serious skin reactions and its effects should be studied further before the U.S. Food and Drug Administration considers its approval to treat acute sinus infections, FDA advisors said in documents released Monday.
The FDA approved Factive in 2003 to treat pneumonia and acute bronchitis, the Associated Press reported. Maker Oscient Pharmaceuticals Corp. has applied for expanded FDA approval to treat acute bacterial sinusitis.
But Factive, in both real-world use and clinical testing, appeared to have a greater risk of skin rashes than similar antibiotics, the AP reported.
On Tuesday, an expert panel advising the FDA will consider whether Factive's benefits outweigh its risks in treating sinus infections. The full agency usually follows the recommendations of its advisory panels in granting or denying approval.