In a unanimous vote Tuesday, an FDA advisory panel recommended the approval of Optimer Pharmaceuticals’ fidaxomycin (Difficid) as a safe and effective treatment for diarrhea caused by the bacterium C. dificile. However, the panel is divided as to whether the oral antibiotic is safe for pregnant women and children and whether it can prevent the recurrence of the bacterial infection. Afflicting more than 700,000 Americans each year, C. dificile infection, which is very difficult to eradicate, occurs in the lining of the colon and can be life threatening.
ACSH's Dr. Josh Bloom is encouraged that the panel has recommended a new antibiotic and posits that if “the FDA does not approve this drug, then no other antibiotic stands a chance. This one seems to be a no-brainer.”
FDA panel recommends important new antibiotic
In a unanimous vote Tuesday, an FDA advisory panel recommended the approval of Optimer Pharmaceuticals’ fidaxomycin (Difficid) as a safe and effective treatment for diarrhea caused by the bacterium C. dificile. However, the panel is divided as to whether the oral antibiotic is safe for pregnant women and children and whether it can prevent the recurrence of the bacterial infection.
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